stay.safe® 050-95012Recalls & reported problems

Summary

The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 10840861100832), received between Aug 17, 2017 and Aug 6, 2026 — classified as 35 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (11 reports).

1 FDA recall record name this device's identifier, 1 still open.

1 other recall cover devices cleared under the same FDA submission (K083542); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Oct 10, 2023Class IIOpen, Classified

   Updating the labeling to include additional warnings and contraindications for potential side effects.

   Z-0507-2024 · Root cause: Labeling design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 48 reports, in the reporter's own words as published by the FDA.

• InjuryAug 6, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Abdominal Pain; Peritoneal effluent abnormal; Peritonitis

  MAUDE report 50168415 ↗
• InjuryMay 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PERITONEAL DIALYSIS (PD) PATIENT WAS DIAGNOSED WITH PERITONITIS. THE PATIENT WAS SEEN IN THE PD CLINIC ON (B)(6) 2026 DUE TO DRAINING ISSUES. DURING THE VISIT, THE PATIENT¿S PD EFFLUENT WAS NOTED TO BE CLOUDY. PD CULTURES WERE OBTAINED. THE PATIENT WAS DIAGNOSED WITH PERITONITIS. THE PATIENT WAS INITIATED ON ANTIBIOTIC THERAPY WITH INTRAPERITONEAL (IP) VANCOMYCIN 1G EVERY 4 DAYS. THE CULTURES WERE POSITIVE FOR ENTEROCOCCUS FAECALIS AND STAPHYLOCOCCUS EPIDERMIDIS. THE CAUSE OF THE PERITONITIS IS ATTRIBUTED TO THE PATIENT HAVING AN EXPOSED PD CATHETER CUFF. THIS HAS BEEN A KNOWN ISSUE FOR SEVERAL MONTHS; HOWEVER, WHEN THE PATIENT CAME TO THE CLINIC ON (B)(6) 2026, THE EXIT SITE WAS NOT COVERED, AND THE CUFF WAS PULLED UP. ADDITIONALLY, THE END OF THE PATIENT¿S PD CATHETER WAS INSIDE HER UNDERPANTS BETWEEN HER LEGS. PRIOR TO THE CLINIC VISIT, THE PATIENT REPORTEDLY HAD DIARRHEA AND ABDOMINAL PAIN FOR 1 MONTH WHICH SHE DID NOT REPORT. THE PDRN SAID THIS PATIENT HAS A HISTORY OF SOCIAL ISSUES IN THE HOME AND HAS BEEN KNOWN TO NOT HAVE THE PD CATHETER CAP ON SECURELY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Peritoneal effluent abnormal; Peritonitis

  MAUDE report 25162023 ↗
• InjuryMay 1, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PD PATIENT ON CONTINUOUS CYCLIC PD (CCPD) THERAPY UTILIZING THE LIBERTY SELECT CYCLER WAS HOSPITALIZED WITH PERITONITIS. THERE WAS NO SPECIFIC ALLEGATION THAT THIS EVENT WAS RELATED TO A DEFICIENCY OR MALFUNCTION OF ANY FRESENIUS DEVICE(S) OR PRODUCT(S) IN THE INITIAL REPORTING. UPON FOLLOW-UP WITH THE PATIENT¿S PDRN, IT WAS REPORTED THAT THIS PATIENT WAS INITIALLY HOSPITALIZED (B)(6) 2026 FOLLOWING AN UNRELATED GASTROINTESTINAL (GI) ILLNESS THAT WAS DETERMINED TO BE UNRELATED TO PD THERAPY OR THE USE OF ANY FRESENIUS PRODUCT(S) OR DEVICE(S). DURING THIS HOSPITAL STAY, THE PATIENT WAS ABLE TO UNDERGO CCPD THERAPY ON A HOSPITAL PROVIDED CYCLER (UNKNOWN BRAND AND MODEL) THAT WAS ASSISTED BY HOSPITAL STAFF. ON HOSPITAL DAY THREE, THE PATIENT BEGAN TO EXPERIENCE NAUSEA AND FEVER. IT WAS REPORTED THAT THE ADMITTING FACILITY DID NOT PROVIDE DIAGNOSTIC LABORATORY RESULTS IN RESPONSE TO THE PATIENT¿S SYMPTOMS. PER THE PATIENT¿S STATEMENT TO THE OUTPATIENT CLINIC, IT WAS REPORTED THAT THE HOSPITAL STAFF THAT WERE ASSISTING WITH PD THERAPY LEFT THE PATIENT¿S UNCAPPED AND EXPOSED PD CATHETER (NOT A FRESENIUS PRODUCT) FOR HOURS ON THE FIRST NIGHT OF ADMISSION. THE PAT

  Patient problems: Fever; Nausea; Peritonitis; Unspecified Gastrointestinal Problem

  MAUDE report 25057569 ↗
• InjuryJan 15, 2026Adverse Event Without Identified Device or Use Problem

  A PERITONEAL DIALYSIS REGISTERED NURSE (PDRN) REPORTED THAT THIS PATIENT ON CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD) HAD BEEN HOSPITALIZED SINCE (B)(6) 2026 DUE TO PERITONITIS. THE PATIENT CAME INTO THE CLINIC WITH NO STAY SAFE CAP ON THE PD CATHETER. ADDITIONAL INFORMATION WAS OBTAINED THROUGH FOLLOW-UP WITH THE PDRN. THE PATIENT WAS SEEN IN THE PD CLINIC ON (B)(6) 2026 DUE TO CLOUDY PD EFFLUENT AND MILD ABDOMINAL PAIN. THE PATIENT WAS NOTED TO HAVE NO STAY SAFE CAP ON THE PD CATHETER. THE PATIENT DID NOT KNOW WHY OR HOW THE CAP HAD GONE MISSING. A PD CULTURE WAS OBTAINED. THE PATIENT WAS DIAGNOSED WITH PERITONITIS. THE PATIENT WENT TO THE EMERGENCY ROOM (ER) THAT SAME DAY. THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2026. THE CULTURES WERE POSITIVE FOR KLEBSIELLA PNEUMONIAE. THE WHITE BLOOD CELL COUNT WAS 116,080 WITH 93% POLYMORPHONUCLEAR (PMN) CELLS. THE PATIENT WAS INITIATED ON ANTIBIOTIC THERAPY WITH INTRAPERITONEAL (IP) CEFTAZIDIME 1.5G DAILY (FOR 14 MORE DAYS). THE PATIENT REMAINS HOSPITALIZED. THE SUSPECTED CAUSE OF THE PERITONITIS EVENT IS THE MISSING STAY SAFE CAP. THE PATIENT DID NOT REQUIRE A PD CATHETER REMOVAL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Abdominal Pain; Peritoneal effluent abnormal; Peritonitis

  MAUDE report 24086960 ↗
• InjuryJan 15, 2026Adverse Event Without Identified Device or Use Problem

  A PERITONEAL DIALYSIS REGISTERED NURSE (PDRN) REPORTED THAT THIS PATIENT ON CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD) HAD BEEN HOSPITALIZED SINCE (B)(6) 2026 DUE TO PERITONITIS. THE PATIENT CAME INTO THE CLINIC WITH NO STAY SAFE CAP ON THE PD CATHETER. ADDITIONAL INFORMATION WAS OBTAINED THROUGH FOLLOW-UP WITH THE PDRN. THE PATIENT WAS SEEN IN THE PD CLINIC ON (B)(6) 2026 DUE TO CLOUDY PD EFFLUENT AND MILD ABDOMINAL PAIN. THE PATIENT WAS NOTED TO HAVE NO STAY SAFE CAP ON THE PD CATHETER. THE PATIENT DID NOT KNOW WHY OR HOW THE CAP HAD GONE MISSING. A PD CULTURE WAS OBTAINED. THE PATIENT WAS DIAGNOSED WITH PERITONITIS. THE PATIENT WENT TO THE EMERGENCY ROOM (ER) THAT SAME DAY. THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2026. THE CULTURES WERE POSITIVE FOR KLEBSIELLA PNEUMONIAE. THE WHITE BLOOD CELL COUNT WAS 116,080 WITH 93% POLYMORPHONUCLEAR (PMN) CELLS. THE PATIENT WAS INITIATED ON ANTIBIOTIC THERAPY WITH INTRAPERITONEAL (IP) CEFTAZIDIME 1.5G DAILY (FOR 14 MORE DAYS). THE PATIENT REMAINS HOSPITALIZED. THE SUSPECTED CAUSE OF THE PERITONITIS EVENT IS THE MISSING STAY SAFE CAP. THE PATIENT DID NOT REQUIRE A PD CATHETER REMOVAL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Abdominal Pain; Peritoneal effluent abnormal; Peritonitis

  MAUDE report 24086956 ↗
• InjuryJun 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PATIENT WITH END STAGE RENAL DISEASE (ESRD) ON CONTINUOUS CYCLIC PERITONEAL DIALYSIS [CC(PD)] UTILIZING A LIBERTY SELECT CYCLER AND LIBERTY CYCLER SET FOR RENAL REPLACEMENT THERAPY (RRT) WAS DIAGNOSED WITH PERITONITIS ON (B)(6) 2025. THE PATIENT¿S PD REGISTERED NURSE (PDRN) REPORTED THE PATIENT CONTRACTED PERITONITIS DUE TO USER ERROR, WHEN SHE FAILED TO UTILIZE A STAY SAFE END CAP AFTER COMPLETING TREATMENT. SUBSEQUENT ATTEMPTS TO OBTAIN ADDITIONAL CLINICAL INFORMATION (E.G., CAUSALITY, DISCHARGE SUMMARY, HOSPITAL RECORDS, MEDICATION RECORDS) WERE UNSUCCESSFUL.

  Patient problems: Peritonitis

  MAUDE report 22143033 ↗
• InjuryJun 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PATIENT WITH END STAGE RENAL DISEASE (ESRD) ON CONTINUOUS CYCLIC PERITONEAL DIALYSIS [CC(PD)] UTILIZING A LIBERTY SELECT CYCLER AND LIBERTY CYCLER SET FOR RENAL REPLACEMENT THERAPY (RRT) WAS DIAGNOSED WITH PERITONITIS ON (B)(6) 2025. THE PATIENT¿S PD REGISTERED NURSE (PDRN) REPORTED THE PATIENT CONTRACTED PERITONITIS DUE TO USER ERROR, WHEN SHE FAILED TO UTILIZE A STAY SAFE END CAP AFTER COMPLETING TREATMENT. SUBSEQUENT ATTEMPTS TO OBTAIN ADDITIONAL CLINICAL INFORMATION (E.G., CAUSALITY, DISCHARGE SUMMARY, HOSPITAL RECORDS, MEDICATION RECORDS) WERE UNSUCCESSFUL.

  Patient problems: Peritonitis

  MAUDE report 22143032 ↗
• InjuryApr 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PATIENT WITH END STAGE RENAL DISEASE (ESRD) ON CONTINUOUS CYCLIC PERITONEAL DIALYSIS [CC(PD)] UTILIZING A LIBERTY SELECT CYCLER AND LIBERTY CYCLER SET FOR RENAL REPLACEMENT THERAPY (RRT) WAS DIAGNOSED WITH PERITONITIS, DUE TO FAILING TO PLACE A STAYSAFE END CAP ON THE PD CATHETER (NOT A FRESENIUS PRODUCT) AT THE TERMINATION OF TREATMENT. FOLLOW-UP WITH THE PATIENTS¿ PD REGISTERED NURSE (PDRN) CONFIRMED THE PATIENT PRESENTED TO THE EMERGENCY ROOM ON (B)(6) 2025 WITH COMPLAINTS OF ABDOMINAL PAIN AND CLOUDY PERITONEAL EFFLUENT FLUID. A PERITONEAL EFFLUENT FLUID CULTURE AND CELL COUNT (WBC = 719 U/L, NEUTROPHILS = 62%) WERE COLLECTED, AND THE PATIENT WAS FORMALLY ADMITTED. THE PATIENT WAS DIAGNOSED WITH PERITONITIS AND WAS TREATED WITH INTRAPERITONEAL (IP) VANCOMYCIN AND CEFTAZIDIME FOR 14 DAYS. THE PATIENT¿S PERITONEAL EFFLUENT CULTURE RESULT RETURNED NEGATIVE FOR GROWTH; HOWEVER, THE PATIENT¿S VANCOMYCIN AND CEFTAZIDIME WERE CONTINUED. THE PATIENT CONTINUED TO UNDERGO CCPD WHILE HOSPITALIZED AND WAS DISCHARGED IN STABLE CONDITION ON (B)(6) 2025. THE PATIENT IS RECOVERING FROM THE SERIOUS ADVERSE EVENTS, AND RESUMED UTILIZING THE SAME LIBERTY SELECT CYCLER AT

  Patient problems: Abdominal Pain; Peritoneal effluent abnormal; Peritonitis

  MAUDE report 21927703 ↗
• InjuryApr 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PATIENT WITH END STAGE RENAL DISEASE (ESRD) ON CONTINUOUS CYCLIC PERITONEAL DIALYSIS [CC(PD)] UTILIZING A LIBERTY SELECT CYCLER AND LIBERTY CYCLER SET FOR RENAL REPLACEMENT THERAPY (RRT) WAS DIAGNOSED WITH PERITONITIS, DUE TO FAILING TO PLACE A STAYSAFE END CAP ON THE PD CATHETER (NOT A FRESENIUS PRODUCT) AT THE TERMINATION OF TREATMENT. FOLLOW-UP WITH THE PATIENTS¿ PD REGISTERED NURSE (PDRN) CONFIRMED THE PATIENT PRESENTED TO THE EMERGENCY ROOM ON (B)(6) 2025 WITH COMPLAINTS OF ABDOMINAL PAIN AND CLOUDY PERITONEAL EFFLUENT FLUID. A PERITONEAL EFFLUENT FLUID CULTURE AND CELL COUNT (WBC = 719 U/L, NEUTROPHILS = 62%) WERE COLLECTED, AND THE PATIENT WAS FORMALLY ADMITTED. THE PATIENT WAS DIAGNOSED WITH PERITONITIS AND WAS TREATED WITH INTRAPERITONEAL (IP) VANCOMYCIN AND CEFTAZIDIME FOR 14 DAYS. THE PATIENT¿S PERITONEAL EFFLUENT CULTURE RESULT RETURNED NEGATIVE FOR GROWTH; HOWEVER, THE PATIENT¿S VANCOMYCIN AND CEFTAZIDIME WERE CONTINUED. THE PATIENT CONTINUED TO UNDERGO CCPD WHILE HOSPITALIZED AND WAS DISCHARGED IN STABLE CONDITION ON (B)(6) 2025. THE PATIENT IS RECOVERING FROM THE SERIOUS ADVERSE EVENTS AND RESUMED UTILIZING THE SAME LIBERTY SELECT CYCLER AT

  Patient problems: Abdominal Pain; Peritoneal effluent abnormal; Peritonitis

  MAUDE report 21927692 ↗
• InjuryApr 15, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT HAD PERITONITIS WHILE SHE WAS AT THE HOSPITAL NOT THAT LONG AGO. ADDITIONAL INFORMATION WAS OBTAINED THROUGH FOLLOW-UP WITH THE PATIENT¿S PERITONEAL DIALYSIS REGISTERED NURSE (PDRN). THE PATIENT WENT TO THE HOSPITAL ON (B)(6) 2025 DUE TO ABDOMINAL PAIN. THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH A DIAGNOSIS OF PERITONITIS. PD CULTURES WERE OBTAINED. THE PATIENT WAS INITIATED ON ANTIBIOTIC THERAPY WITH INTRAPERITONEAL (IP) CEFEPIME (DOSE UNKNOWN) DAILY UNTIL (B)(6) 2025. THE PD CULTURES RESULTED POSITIVE FOR PSEUDOMONAS AERUGINOSA. THE PATIENT WAS DISCHARGED ON (B)(6) 2025. THE PATIENT IS CONTINUING WITH THE ANTIBIOTIC THERAPY DURING RECOVERY. THE CAUSE OF THE PERITONITIS WAS DETERMINED TO BE THE CAP FALLING OFF THE PD CATHETER SOME TIME SHORTLY PRIOR TO THE HOSPITALIZATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Abdominal Pain; Peritonitis

  MAUDE report 21839642 ↗
• InjuryJan 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 13/JAN/2025, FRESENIUS BECAME AWARE THIS PATIENT WITH END STAGE RENAL DISEASE (ESRD) ON CONTINUOUS CYCLIC PERITONEAL DIALYSIS [CC(PD)] UTILIZING A LIBERTY SELECT CYCLER, LIBERTY CYCLER SET AND STAY SAFE CAP FOR RENAL REPLACEMENT THERAPY (RRT) CONTRACTED PERITONITIS, AND HIS PD CATHETER (NOT A FRESENIUS PRODUCT) WAS REMOVED. NO ADDITIONAL INFORMATION WAS PROVIDED DURING THE INTAKE PROCESS. FOLLOW-UP WITH THE PATIENT¿S PD REGISTERED NURSE [(PD)RN] CONFIRMED THE PATIENT PRESENTED TO THE EMERGENCY ROOM ON (B)(6) 2025 WITH COMPLAINTS OF ABDOMINAL PAIN AND CLOUDY PERITONEAL EFFLUENT FLUID. A PERITONEAL EFFLUENT FLUID CULTURE AND CELL COUNT (RESULTS UNAVAILABLE) WERE COLLECTED, AND THE PATIENT WAS FORMALLY ADMITTED. THE PATIENT WAS DIAGNOSED WITH PERITONITIS AND TREATED WITH INTRAPERITONEAL (IP) VANCOMYCIN 2000 MG EVERY THREE DAYS AND CEFTAZIDIME 1500 MG DAILY FOR 14 DAYS. THE PATIENT¿S PERITONEAL EFFLUENT CULTURE RESULT RETURNED POSITIVE FOR METHICILLIN RESISTANT STAPHYLOCOCCUS AUREUS (MRSA) ON (B)(6) 2025, AND THE PATIENT¿S ANTIBIOTICS WERE CONTINUED. UPON RECEIVING THE PERITONEAL EFFLUENT FLUID CULTURE RESULTS, THE NEPHROLOGIST ORDERED THE REMOVAL OF THE PATIENT¿S PD CATHETER ON (B)

  Patient problems: Abdominal Pain; Peritonitis

  MAUDE report 21183173 ↗
• InjuryJan 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO FRESENIUS CUSTOMER SERVICE THAT A PERITONEAL DIALYSIS (PD) PATIENT WAS HOSPITALIZED DUE TO PERITONITIS. NO ADDITIONAL INFORMATION WAS PROVIDED DURING THE INITIAL REPORTING. FOLLOW-UP WITH THE PATIENT¿S PD REGISTERED NURSE (PDRN) CONFIRMED THE PATIENT PRESENTED TO THE EMERGENCY ROOM (ER) ON (B)(6) 2024 WITH COMPLAINTS OF ABDOMINAL PAIN, ABDOMINAL CRAMPING, AND CLOUDY PERITONEAL EFFLUENT FLUID. A PERITONEAL EFFLUENT FLUID CULTURE AND CELL COUNT (WBC = 9,278 U/L, POLYMORPH CELLS = 97%) WERE COLLECTED, AND THE PATIENT WAS DIAGNOSED WITH PERITONITIS. THE PATIENT WAS ADMITTED AND TREATED WITH INTRAPERITONEAL (IP) CEFTRIAXONE 1000 MG DAILY, ORAL LEVOFLOXACIN 250 MG EVERY 48 HOURS, AND ORAL FLUCONAZOLE 100 MG DAILY FOR 18 DAYS. THE PATIENT¿S PRELIMINARY PERITONEAL EFFLUENT CULTURE RESULT RETURNED POSITIVE FOR KLEBSIELLA OXYTOCA AND ENTEROBACTER CLOACAE ON (B)(6) 2024, AND THE PATIENT¿S ANTIBIOTICS WERE CONTINUED. THE PDRN ATTRIBUTED CAUSALITY TO A POORLY TIGHTENED END CAP WHICH BECAME DISLODGED AND LEAKED FLUID. THE PATIENT WRAPPED THE PD CATHETER (NOT A FRESENIUS PRODUCT) WITH NON-OCCLUSIVE PAPER TAPE WHICH WAS SATURATED UPON THEIR ARRIVAL TO THE ER. THE PATIENT WAS DIS

  Patient problems: Abdominal Cramps; Abdominal Pain; Peritonitis

  MAUDE report 21175422 ↗
• InjuryJan 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO FRESENIUS CUSTOMER SERVICE THAT A PERITONEAL DIALYSIS (PD) PATIENT WAS HOSPITALIZED DUE TO PERITONITIS. NO ADDITIONAL INFORMATION WAS PROVIDED DURING THE INITIAL REPORTING. FOLLOW-UP WITH THE PATIENT¿S PD REGISTERED NURSE (PDRN) CONFIRMED THE PATIENT PRESENTED TO THE EMERGENCY ROOM (ER) ON (B)(6) 2024 WITH COMPLAINTS OF ABDOMINAL PAIN, ABDOMINAL CRAMPING, AND CLOUDY PERITONEAL EFFLUENT FLUID. A PERITONEAL EFFLUENT FLUID CULTURE AND CELL COUNT (WBC = 9,278 U/L, POLYMORPH CELLS = 97%) WERE COLLECTED, AND THE PATIENT WAS DIAGNOSED WITH PERITONITIS. THE PATIENT WAS ADMITTED AND TREATED WITH INTRAPERITONEAL (IP) CEFTRIAXONE 1000 MG DAILY, ORAL LEVOFLOXACIN 250 MG EVERY 48 HOURS, AND ORAL FLUCONAZOLE 100 MG DAILY FOR 18 DAYS. THE PATIENT¿S PRELIMINARY PERITONEAL EFFLUENT CULTURE RESULT RETURNED POSITIVE FOR KLEBSIELLA OXYTOCA AND ENTEROBACTER CLOACAE ON (B)(6) 2024, AND THE PATIENT¿S ANTIBIOTICS WERE CONTINUED. THE PDRN ATTRIBUTED CAUSALITY TO A POORLY TIGHTENED END CAP WHICH BECAME DISLODGED AND LEAKED FLUID. THE PATIENT WRAPPED THE PD CATHETER (NOT A FRESENIUS PRODUCT) WITH NON-OCCLUSIVE PAPER TAPE WHICH WAS SATURATED UPON THEIR ARRIVAL TO THE ER. THE PATIENT WAS DIS

  Patient problems: Abdominal Cramps; Abdominal Pain; Peritonitis

  MAUDE report 21175417 ↗
• InjuryJan 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 13/JAN/2025, FRESENIUS BECAME AWARE THIS PATIENT WITH END STAGE RENAL DISEASE (ESRD) ON CONTINUOUS CYCLIC PERITONEAL DIALYSIS [CC(PD)] UTILIZING A LIBERTY SELECT CYCLER, LIBERTY CYCLER SET AND STAY SAFE CAP FOR RENAL REPLACEMENT THERAPY (RRT) CONTRACTED PERITONITIS, AND HIS PD CATHETER (NOT A FRESENIUS PRODUCT) WAS REMOVED. NO ADDITIONAL INFORMATION WAS PROVIDED DURING THE INTAKE PROCESS. FOLLOW-UP WITH THE PATIENT¿S PD REGISTERED NURSE [(PD)RN] CONFIRMED THE PATIENT PRESENTED TO THE EMERGENCY ROOM ON (B)(6)2025 WITH COMPLAINTS OF ABDOMINAL PAIN AND CLOUDY PERITONEAL EFFLUENT FLUID. A PERITONEAL EFFLUENT FLUID CULTURE AND CELL COUNT (RESULTS UNAVAILABLE) WERE COLLECTED, AND THE PATIENT WAS FORMALLY ADMITTED. THE PATIENT WAS DIAGNOSED WITH PERITONITIS AND TREATED WITH INTRAPERITONEAL (IP) VANCOMYCIN 2000 MG EVERY THREE DAYS AND CEFTAZIDIME 1500 MG DAILY FOR 14 DAYS. THE PATIENT¿S PERITONEAL EFFLUENT CULTURE RESULT RETURNED POSITIVE FOR METHICILLIN RESISTANT STAPHYLOCOCCUS AUREUS (MRSA) ON (B)(6)2025, AND THE PATIENT¿S ANTIBIOTICS WERE CONTINUED. UPON RECEIVING THE PERITONEAL EFFLUENT FLUID CULTURE RESULTS, THE NEPHROLOGIST ORDERED THE REMOVAL OF THE PATIENT¿S PD CATHETER ON (B)(6

  Patient problems: Abdominal Pain; Peritonitis

  MAUDE report 21169589 ↗
• InjuryJan 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED DURING FOLLOW UP THAT THIS PERITONEAL DIALYSIS (PD) PATIENT ON CONTINUOUS CYCLIC PD (CCPD) THERAPY UTILIZING THE LIBERTY SELECT CYCLER EXPERIENCED PERITONITIS. THERE WAS NO SPECIFIC ALLEGATION THESE ADVERSE EVENTS WERE DUE TO A DEFICIENCY OR MALFUNCTION OF ANY FRESENIUS PRODUCT(S) OR DEVICE(S) IN THE INITIAL REPORTING. UPON FOLLOW-UP WITH THIS PATIENT¿S PD REGISTERED NURSE, IT WAS REPORTED THIS PATIENT PRESENTED TO THE OUTPATIENT CLINIC ON (B)(6) 2024 FOLLOWING ABDOMINAL PAIN AND CLOUDY PERITONEAL EFFLUENT FLUID NOTED AT HOME. PERITONEAL EFFLUENT FLUID CULTURES AND A WHITE BLOOD CELL (WBC) COUNT TAKEN IN THE OUTPATIENT CLINIC ON (B)(6) 2024 PRESENTED WITH GRAM-NEGATIVE BACILLI (ORGANISM NOT REPORTED) IN THE CULTURE AND A WBC COUNT OF 1700/MM3. THE PATIENT WAS DIAGNOSED WITH PERITONITIS DUE TO A BREAK IN ASEPSIS TO HIS PD CATHETER (NOT A FRESENIUS PRODUCT). IT WAS EXPLAINED THE PATIENT WAS FOUND NOT TO HAVE THE STAY-SAFE CAP ON HIS CATHETER ON MULTIPLE OCCASIONS PRIOR TO THIS INFECTION. THERE WAS NO INDICATION OF AN ISSUE WITH THE PATIENT¿S CATHETER STAY-SAFE CAP, RATHER IT WAS DETERMINED THE CAP WAS NOT APPROPRIATELY REPLACED BY THE PATIENT FOLLOWING THERAPY. THE PA

  Patient problems: Abdominal Pain; Peritonitis

  MAUDE report 21103414 ↗
• InjuryJan 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED DURING FOLLOW UP THAT THIS PERITONEAL DIALYSIS (PD) PATIENT ON CONTINUOUS CYCLIC PD (CCPD) THERAPY UTILIZING THE LIBERTY SELECT CYCLER EXPERIENCED PERITONITIS. THERE WAS NO SPECIFIC ALLEGATION THESE ADVERSE EVENTS WERE DUE TO A DEFICIENCY OR MALFUNCTION OF ANY FRESENIUS PRODUCT(S) OR DEVICE(S) IN THE INITIAL REPORTING. UPON FOLLOW-UP WITH THIS PATIENT¿S PD REGISTERED NURSE, IT WAS REPORTED THIS PATIENT PRESENTED TO THE OUTPATIENT CLINIC ON (B)(6) 2024 FOLLOWING ABDOMINAL PAIN AND CLOUDY PERITONEAL EFFLUENT FLUID NOTED AT HOME. PERITONEAL EFFLUENT FLUID CULTURES AND A WHITE BLOOD CELL (WBC) COUNT TAKEN IN THE OUTPATIENT CLINIC ON (B)(6) 2024 PRESENTED WITH GRAM-NEGATIVE BACILLI (ORGANISM NOT REPORTED) IN THE CULTURE AND A WBC COUNT OF 1700/MM3. THE PATIENT WAS DIAGNOSED WITH PERITONITIS DUE TO A BREAK IN ASEPSIS TO HIS PD CATHETER (NOT A FRESENIUS PRODUCT). IT WAS EXPLAINED THE PATIENT WAS FOUND NOT TO HAVE THE STAY-SAFE CAP ON HIS CATHETER ON MULTIPLE OCCASIONS PRIOR TO THIS INFECTION. THERE WAS NO INDICATION OF AN ISSUE WITH THE PATIENT¿S CATHETER STAY-SAFE CAP, RATHER IT WAS DETERMINED THE CAP WAS NOT APPROPRIATELY REPLACED BY THE PATIENT FOLLOWING THERAPY. THE PA

  Patient problems: Abdominal Pain; Peritonitis

  MAUDE report 21103392 ↗
• InjuryNov 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PERITONEAL DIALYSIS REGISTERED NURSE [(PD)RN] REPORTED THAT THIS PD PATIENT WAS HOSPITALIZED FOR PERITONITIS. THE PATIENT REPORTEDLY ARRIVED AT THE CLINIC WITHOUT A STAY-SAFE CAP ON THE PD CATHETER (NOT A FRESENIUS PRODUCT). ADDITIONAL INFORMATION WAS OBTAINED THROUGH FOLLOW-UP WITH THE PDRN. THE PATIENT WAS SEEN IN THE CLINIC IN (B)(6) 2024 DUE TO ISSUES WITH THE PD CATHETER. WHEN THE PATIENT ARRIVED, THERE WAS NO STAY-SAFE CAP ON THE PD CATHETER. THE PATIENT¿S TRANSFER SET WAS CHANGED PER THE MD INSTRUCTIONS. THE PATIENT WAS SENT TO THE HOSPITAL FROM THE CLINIC. THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2024 FOR A NON-FUNCTIONING PD CATHETER AND PERITONITIS. THE PDRN DID NOT HAVE ANY CULTURE RESULTS OR ANTIBIOTIC INFORMATION AVAILABLE. THE PATIENT¿S ANTIBIOTICS WERE ADMINISTERED IN THE HOSPITAL. DURING THE HOSPITALIZATION, THE PATIENT¿S PD CATHETER WAS REMOVED, AND THE PATIENT WAS TRANSITIONED TO HEMODIALYSIS (HD). THE PATIENT WAS DISCHARGED ON (B)(6) 2024. THE PATIENT IS COMPLETING BACK-UP HD UNTIL DECEMBER WHEN THE PATIENT WILL RECEIVE A NEW PD CATHETER AND RETURN TO PD. THE CAUSE OF THE PERITONITIS HAS BEEN ATTRIBUTED TO NOT HAVING THE STAY SAFE CAP ON THE PD CATHET

  Patient problems: Peritonitis

  MAUDE report 20737057 ↗
• InjuryNov 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PERITONEAL DIALYSIS REGISTERED NURSE [(PD)RN] REPORTED THAT THIS PD PATIENT WAS HOSPITALIZED FOR PERITONITIS. THE PATIENT REPORTEDLY ARRIVED AT THE CLINIC WITHOUT A STAY-SAFE CAP ON THE PD CATHETER (NOT A FRESENIUS PRODUCT). ADDITIONAL INFORMATION WAS OBTAINED THROUGH FOLLOW-UP WITH THE PDRN. THE PATIENT WAS SEEN IN THE CLINIC IN (B)(6) 2024 DUE TO ISSUES WITH THE PD CATHETER. WHEN THE PATIENT ARRIVED, THERE WAS NO STAY-SAFE CAP ON THE PD CATHETER. THE PATIENT¿S TRANSFER SET WAS CHANGED PER THE MD INSTRUCTIONS. THE PATIENT WAS SENT TO THE HOSPITAL FROM THE CLINIC. THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2024 FOR A NON-FUNCTIONING PD CATHETER AND PERITONITIS. THE PDRN DID NOT HAVE ANY CULTURE RESULTS OR ANTIBIOTIC INFORMATION AVAILABLE. THE PATIENT¿S ANTIBIOTICS WERE ADMINISTERED IN THE HOSPITAL. DURING THE HOSPITALIZATION, THE PATIENT¿S PD CATHETER WAS REMOVED, AND THE PATIENT WAS TRANSITIONED TO HEMODIALYSIS (HD). THE PATIENT WAS DISCHARGED ON (B)(6) 2024. THE PATIENT IS COMPLETING BACK-UP HD UNTIL DECEMBER WHEN THE PATIENT WILL RECEIVE A NEW PD CATHETER AND RETURN TO PD. THE CAUSE OF THE PERITONITIS HAS BEEN ATTRIBUTED TO NOT HAVING THE STAY SAFE CAP ON THE PD CATHET

  Patient problems: Peritonitis

  MAUDE report 20725590 ↗
• InjuryJul 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 22/JUL/2024 DURING FOLLOW-UP, FRESENIUS BECAME AWARE THIS PATIENT WITH END STAGE RENAL DISEASE (ESRD) ON CONTINUOUS CYCLIC PERITONEAL DIALYSIS [CC(PD)] UTILIZING A LIBERTY SELECT CYCLER AND LIBERTY CYCLER SET FOR RENAL REPLACEMENT THERAPY (RRT) WAS HOSPITALIZED DUE TO DRAIN COMPLICATIONS AND PERITONITIS. NO ADDITIONAL INFORMATION WAS PROVIDED DURING INTAKE. DURING FOLLOW-UP, THE PATIENT¿S PD REGISTERED NURSE (PDRN) CONFIRMED THE PATIENT PRESENTED TO THE EMERGENCY ROOM (ER) ON 12/JUL/2024 WITH COMPLAINTS OF ABDOMINAL PAIN AND CLOUDY PERITONEAL EFFLUENT FLUID. A PERITONEAL EFFLUENT FLUID CULTURE AND CELL COUNT (RESULTS UNAVAILABLE) WERE COLLECTED, AND THE PATIENT WAS DIAGNOSED WITH PERITONITIS. THE PATIENT WAS ADMITTED AND TREATED WITH INTRAPERITONEAL (IP) VANCOMYCIN 2000 MG EVERY 3 DAYS, AND GENTAMYCIN 160 MG DAILY (DUE TO CEFTAZIDIME ALLERGY) FOR 21 DAYS. THE PATIENT¿S PERITONEAL EFFLUENT CULTURE RESULT RETURNED POSITIVE FOR STAPHYLOCOCCUS AUREUS ON 17/JUL/2024, AND THE PATIENT¿S GENTAMYCIN WAS DISCONTINUED. THE PATIENT CONTINUED TO UNDERGO CCPD THERAPY WHILE HOSPITALIZED AND IS RECOVERING FROM THE SERIOUS ADVERSE EVENTS. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2024 IN STABLE

  Patient problems: Abdominal Pain; Peritonitis

  MAUDE report 19827699 ↗
• InjuryJul 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2024 DURING FOLLOW-UP, FRESENIUS BECAME AWARE THIS PATIENT WITH END STAGE RENAL DISEASE (ESRD) ON CONTINUOUS CYCLIC PERITONEAL DIALYSIS [CC(PD)] UTILIZING A LIBERTY SELECT CYCLER AND LIBERTY CYCLER SET FOR RENAL REPLACEMENT THERAPY (RRT) WAS HOSPITALIZED DUE TO DRAIN COMPLICATIONS AND PERITONITIS. NO ADDITIONAL INFORMATION WAS PROVIDED DURING INTAKE. DURING FOLLOW-UP, THE PATIENT¿S PD REGISTERED NURSE (PDRN) CONFIRMED THE PATIENT PRESENTED TO THE EMERGENCY ROOM (ER) ON 12/JUL/2024 WITH COMPLAINTS OF ABDOMINAL PAIN AND CLOUDY PERITONEAL EFFLUENT FLUID. A PERITONEAL EFFLUENT FLUID CULTURE AND CELL COUNT (RESULTS UNAVAILABLE) WERE COLLECTED, AND THE PATIENT WAS DIAGNOSED WITH PERITONITIS. THE PATIENT WAS ADMITTED AND TREATED WITH INTRAPERITONEAL (IP) VANCOMYCIN 2000 MG EVERY 3 DAYS, AND GENTAMYCIN 160 MG DAILY (DUE TO CEFTAZIDIME ALLERGY) FOR 21 DAYS. THE PATIENT¿S PERITONEAL EFFLUENT CULTURE RESULT RETURNED POSITIVE FOR STAPHYLOCOCCUS AUREUS ON (B)(6) 2024, AND THE PATIENT¿S GENTAMYCIN WAS DISCONTINUED. THE PATIENT CONTINUED TO UNDERGO CCPD THERAPY WHILE HOSPITALIZED AND IS RECOVERING FROM THE SERIOUS ADVERSE EVENTS. THE PATIENT WAS DISCHARGED HOME ON 19/JUL/2024 IN STABLE

  Patient problems: Abdominal Pain; Peritonitis

  MAUDE report 19827623 ↗
• InjuryJul 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT WAS DIAGNOSED WITH A STAPHYLOCOCCUS AUREUS AND PERITONITIS INFECTION. FOLLOW-UP WITH THE PATIENT¿S PD REGISTERED NURSE (PDRN) REVEALED THE PATIENT PRESENTED TO THE OUTPATIENT HOME DIALYSIS CLINIC ON 14/JUN/2024 WITH COMPLAINTS OF ABDOMINAL PAIN, ABDOMINAL CRAMPING, AND CLOUDY PERITONEAL EFFLUENT FLUID. A PERITONEAL EFFLUENT FLUID CULTURE AND CELL COUNT (WBC = 412 U/L, NEUTROPHILS = 85%) WERE COLLECTED, AND THE PATIENT WAS DIAGNOSED WITH PERITONITIS. THE PATIENT WAS TREATED AS AN OUTPATIENT WITH INTRAPERITONEAL (IP) VANCOMYCIN 2000 MG EVERY 5 DAYS, AND FORTAZ 2000 MG DAILY FOR 21 DAYS. THE PATIENT¿S PERITONEAL EFFLUENT CULTURE RESULT RETURNED POSITIVE FOR STAPHYLOCOCCUS AUREUS ON 19/JUN/2024, AND THE PATIENT¿S VANCOMYCIN AND FORTAZ WERE DISCONTINUED AND REPLACED WITH CEFAZOLIN 2000 MG DAILY FOR 21 DAYS. THE PATIENT IS RECOVERING FROM THE SERIOUS ADVERSE EVENTS AND CONTINUES TO UNDERGO CCPD THERAPY AT HOME UTILIZING THE SAME LIBERTY SELECT CYCLER WITHOUT REPORTED ISSUE. THE PDRN ATTRIBUTED CAUSALITY TO A TOUCH CONTAMINATION EVENT, AS THE PATIENT REPORTED EXPERIENCING DIFFICULTY OPENING THE STAY-SAFE-CAP PACKAGING AND TOUCHED THE

  Patient problems: Abdominal Cramps; Abdominal Pain; Peritonitis

  MAUDE report 19666902 ↗
• InjuryJul 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT WAS DIAGNOSED WITH A STAPHYLOCOCCUS AUREUS AND PERITONITIS INFECTION. FOLLOW-UP WITH THE PATIENT¿S PD REGISTERED NURSE (PDRN) REVEALED THE PATIENT PRESENTED TO THE OUTPATIENT HOME DIALYSIS CLINIC ON (B)(6) 2024 WITH COMPLAINTS OF ABDOMINAL PAIN, ABDOMINAL CRAMPING, AND CLOUDY PERITONEAL EFFLUENT FLUID. A PERITONEAL EFFLUENT FLUID CULTURE AND CELL COUNT (WBC = 412 U/L, NEUTROPHILS = 85%) WERE COLLECTED, AND THE PATIENT WAS DIAGNOSED WITH PERITONITIS. THE PATIENT WAS TREATED AS AN OUTPATIENT WITH INTRAPERITONEAL (IP) VANCOMYCIN 2000 MG EVERY 5 DAYS, AND FORTAZ 2000 MG DAILY FOR 21 DAYS. THE PATIENT¿S PERITONEAL EFFLUENT CULTURE RESULT RETURNED POSITIVE FOR STAPHYLOCOCCUS AUREUS ON (B)(6) 2024, AND THE PATIENT¿S VANCOMYCIN AND FORTAZ WERE DISCONTINUED AND REPLACED WITH CEFAZOLIN 2000 MG DAILY FOR 21 DAYS. THE PATIENT IS RECOVERING FROM THE SERIOUS ADVERSE EVENTS AND CONTINUES TO UNDERGO CCPD THERAPY AT HOME UTILIZING THE SAME LIBERTY SELECT CYCLER WITHOUT REPORTED ISSUE. THE PDRN ATTRIBUTED CAUSALITY TO A TOUCH CONTAMINATION EVENT, AS THE PATIENT REPORTED EXPERIENCING DIFFICULTY OPENING THE STAY-SAFE-CAP PACKAGING AND TOUCHED THE

  Patient problems: Abdominal Cramps; Abdominal Pain; Peritonitis

  MAUDE report 19666678 ↗
• InjuryMay 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO FRESENIUS THAT A PATIENT WITH END STAGE RENAL DISEASE (ESRD) ON CONTINUOUS CYCLIC PERITONEAL DIALYSIS [CC(PD)] FOR RENAL REPLACEMENT THERAPY (RRT) WAS HOSPITALIZED FOR AN UNSPECIFIED INFECTION, AND TEMPORARILY TRANSITIONED TO HEMODIALYSIS (HD). DURING FOLLOW-UP, THE PATIENT¿S PD REGISTERED NURSE (PDRN) REPORTED THE PATIENT PRESENTED TO THE EMERGENCY ROOM ON (B)(6) 2024 WITH COMPLAINTS OF ABDOMINAL PAIN AND CLOUDY PERITONEAL EFFLUENT FLUID. A PERITONEAL EFFLUENT FLUID CULTURE AND CELL COUNT (WBC ELEVATED) WERE COLLECTED, AND THE PATIENT WAS DIAGNOSED WITH PERITONITIS. THE PATIENT WAS TREATED WITH INTRAPERITONEAL (IP) CEFTAZIDIME 1500 MG DAILY, AND VANCOMYCIN 2000 MG EVERY OTHER DAY FOR 21 DAYS. ON (B)(6) 2024, THE PATIENT¿S PERITONEAL EFFLUENT CULTURE RESULT RETURNED POSITIVE FOR STAPHYLOCOCCUS AUREUS, AND THE PATIENT¿S CEFTAZIDIME AND VANCOMYCIN WERE DISCONTINUED AND REPLACED WITH INTRAVENOUS (IV) ROCEPHIN (DOSAGE, FREQUENCY, DURATION NOT PROVIDED). THE PATIENT ENCOUNTERED PD CATHETER (NOT A FRESENIUS PRODUCT) ISSUES WHILE HOSPITALIZED AND REQUIRED A SURGICAL REVISION. THE PATIENT WAS TEMPORARILY TRANSITIONED TO HD TO ALLOW THE PATIENT¿S ABDOMEN TIME TO HEAL. THE

  Patient problems: Abdominal Pain; Peritonitis

  MAUDE report 19316099 ↗
• InjuryMay 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO FRESENIUS THAT A PATIENT WITH END STAGE RENAL DISEASE (ESRD) ON CONTINUOUS CYCLIC PERITONEAL DIALYSIS [CC(PD)] FOR RENAL REPLACEMENT THERAPY (RRT) WAS HOSPITALIZED FOR AN UNSPECIFIED INFECTION, AND TEMPORARILY TRANSITIONED TO HEMODIALYSIS (HD). DURING FOLLOW-UP, THE PATIENT¿S PD REGISTERED NURSE (PDRN) REPORTED THE PATIENT PRESENTED TO THE EMERGENCY ROOM ON (B)(6) 2024 WITH COMPLAINTS OF ABDOMINAL PAIN AND CLOUDY PERITONEAL EFFLUENT FLUID. A PERITONEAL EFFLUENT FLUID CULTURE AND CELL COUNT (WBC ELEVATED) WERE COLLECTED, AND THE PATIENT WAS DIAGNOSED WITH PERITONITIS. THE PATIENT WAS TREATED WITH INTRAPERITONEAL (IP) CEFTAZIDIME 1500 MG DAILY, AND VANCOMYCIN 2000 MG EVERY OTHER DAY FOR 21 DAYS. ON (B)(6) 2024, THE PATIENT¿S PERITONEAL EFFLUENT CULTURE RESULT RETURNED POSITIVE FOR STAPHYLOCOCCUS AUREUS, AND THE PATIENT¿S CEFTAZIDIME AND VANCOMYCIN WERE DISCONTINUED AND REPLACED WITH INTRAVENOUS (IV) ROCEPHIN (DOSAGE, FREQUENCY, DURATION NOT PROVIDED). THE PATIENT ENCOUNTERED PD CATHETER (NOT A FRESENIUS PRODUCT) ISSUES WHILE HOSPITALIZED AND REQUIRED A SURGICAL REVISION. THE PATIENT WAS TEMPORARILY TRANSITIONED TO HD TO ALLOW THE PATIENT¿S ABDOMEN TIME TO HEAL. THE

  Patient problems: Abdominal Pain; Peritonitis

  MAUDE report 19316093 ↗
• InjuryMar 13, 2023Material Disintegration; Material Disintegration

  A REGISTERED NURSE (RN) REPORTED THAT A PATIENT ON PERITONEAL DIALYSIS (PD) DEVELOPED AN INFECTION ON (B)(6) 2023 CHARACTERIZED BY FEVER, DIARRHEA, CRAMPING, POOR APPETITE AND HYPOTENSION. THE RN STATED THE INFECTION WAS CAUSED BY AN ISSUE WITH 2 LOTS OF THE FRESENIUS STAY SAFE CAPS. THE PATIENT WAS RECEIVING ANTIBIOTICS IN THE OUTPATIENT PD CLINIC. IN AN ADDITIONAL FOLLOW-UP CALL, THE REPORTING NURSE CONFIRMED THE PATIENT WAS EXPERIENCING SYMPTOMS (NOTED ABOVE) ON THE MORNING OF (B)(6) 2023. AS A RESULT, THE PATIENT WAS SEEN IN THE OUTPATIENT PD CLINIC AND HAD A PD CULTURE OBTAINED. PER THE NURSE, THE PD CULTURE YIELDED GROWTH OF THE ORGANISM PARACOCCUS YEEI. THE PATIENT WAS TREATED WITH INTRA-PERITONEAL (IP) VANCOMYCIN (PER CLINIC DOSING) ON AN OUTPATIENT BASIS. THE NURSE INDICATED THE PATIENT RECOVERED FROM THE PERITONITIS EVENT. THE PATIENT CONTINUES PD THERAPY WITH THE SAME CYCLER AND A NEW BOX OF STAY SAFE CAPS (PROVIDED BY THE OUTPATIENT PD CLINIC) WITHOUT FURTHER REPORTED ISSUES. THE NURSE STATED THE PERITONITIS IS NOT RELATED TO ANY FLUID LEAKS OR ANY ISSUES WITH THE FRESENIUS CYCLER/CYCLER SET. THE PATIENT HAS A FRESENIUS EXTENSION SET THAT IS ATTACHED TO THE PD CATHETER

  Patient problems: Cramp(s) /Muscle Spasm(s); Decreased Appetite; Diarrhea; Fever; Low Blood Pressure/ Hypotension; Peritonitis

  MAUDE report 16530448 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K083542. One submission often covers many models, so check the product and lot details in each record.

• Z-2090-2021 · Apr 28, 2021 · Terminated
  050-95012 Sterile Stay Safe Cap The Indications for Use/Intended Use for the Fresenius Sterile Stay Safe Cap is equivalent to that for the Fresenius Stay Safe Cap and is as follows