stay.safeRecalls & reported problems across all models

We found 8 models of stay.safe by Fresenius Medical Care Holdings, Inc. in the FDA's device registry (GUDID). Together they are named in 187 adverse event reports in the FDA's MAUDE database, received between Jun 15, 2017 and Aug 6, 2026 — classified as 97 injuries, 90 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (93 reports).

6 FDA recall records name at least one of these models by its device identifier, 6 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

stay.safe recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Jan 23, 2024Open, Classified

   The peroxide cross-linked tubing has leachables identified as NDL PCBAs.

   Z-1327-2024 · Root cause: Device Design · Recall details · FDA record ↗

2. Jan 23, 2024Open, Classified

   The peroxide cross-linked tubing has leachables identified as NDL PCBAs.

   Z-1326-2024 · Root cause: Device Design · Recall details · FDA record ↗

3. Jan 23, 2024Open, Classified

   The peroxide cross-linked tubing has leachables identified as NDL PCBAs.

   Z-1325-2024 · Root cause: Device Design · Recall details · FDA record ↗

4. Jan 23, 2024Open, Classified

   The peroxide cross-linked tubing has leachables identified as NDL PCBAs.

   Z-1324-2024 · Root cause: Device Design · Recall details · FDA record ↗

5. Jan 23, 2024Open, Classified

   The peroxide cross-linked tubing has leachables identified as NDL PCBAs.

   Z-1323-2024 · Root cause: Device Design · Recall details · FDA record ↗

6. Oct 10, 2023Open, 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 stay.safe problems

stay.safe models

8 models, most reported first. Each model has its own page with its reports, recalls and device details.

• stay.safe® 050-95012

  SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
  1 recall48 reports
• stay.safe® 050-95004

  SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
  1 recall43 reports
• stay.safe® 050-95005

  SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
  1 recall34 reports
• stay.safe® 050-95001

  SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
  1 recall20 reports
• stay.safe® 050-95003

  SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
  1 recall11 reports
• stay.safe® 050-95013

  SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
  1 recall2 reports
• stay.safe® 050-50758

  SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
  28 reports
• stay.safe® 026-20030

  SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
  1 report

Recent stay.safe adverse event reports

The 15 most recent reports across all models, 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 ↗
• MalfunctionJul 17, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25859906 ↗
• InjuryJun 11, 2026Material Puncture/Hole

  A NURSE REPORTED THAT THIS PATIENT ON CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD) THERAPY WAS IN THE HOSPITAL DUE TO PERITONITIS. THE PD CATHETER (NOT A FRESENIUS PRODUCT) WAS PLANNED TO BE PULLED AND REPLACED. ADDITIONAL INFORMATION WAS OBTAINED THROUGH FOLLOW-UP WITH THE PATIENT¿S PERITONEAL DIALYSIS REGISTERED NURSE (PDRN). THE PATIENT WAS SEEN IN THE PD CLINIC ON (B)(6) 2026 DUE TO ABDOMINAL PAIN AND CLOUDY EFFLUENT. THE PATIENT WAS FOUND TO HAVE A LARGE HOLE IN THE STAY SAFE/LUER LOCK CATHETER EXT SET. THE PATIENT DENIED KNOWING HOW THE SET GOT A HOLE IN IT. THE PATIENT DID NOT KNOW WHEN IT HAPPENED BUT STATED HE NOTICED FLUID DRIPPING FROM IT FOR AT LEAST A COUPLE OF DAYS. THE PATIENT NEVER REPORTED THE ISSUE TO THE CLINIC UNTIL HE WAS SEEN. THE EXTENSION SET WAS CHANGED OUT, AND THE DAMAGED ONE WAS DISCARDED. PD CULTURES WERE OBTAINED. ON (B)(6) 2026 THE CULTURES RETURNED POSITIVE FOR KLEBSIELLA PNEUMONIAE. THE PATIENT WAS THEN DIAGNOSED WITH PERITONITIS. THE WHITE BLOOD CELL (WBC) COUNT WAS 1255 WITH 72% POLYMORPHONUCLEAR (PMN) CELLS. THE PATIENT WAS PRESCRIBED ANTIBIOTICS WITH INTRAPERITONEAL (IP) CEFTAZIDIME 1G DAILY AND LEVAQUIN 500MG 1 TIME DOSE AND THEN 250MG DAIL

  Patient problems: Abdominal Pain; Peritoneal effluent abnormal; Peritonitis

  MAUDE report 25470739 ↗
• 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 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PERITONEAL DIALYSIS (PD) PATIENT REPORTED BEING HOSPITALIZED DUE TO PERITONITIS. 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) 2026 DUE TO ABDOMINAL PAIN. THE PATIENT HAD A CRACK IN THE PD CATHETER EXTENSION SET THAT WAS LEAKING DURING FILL AND DRAIN. THE CRACK WAS LOCATED NEAR THE DISTAL END AT THE BOTTOM PART OF THE BLUE HUB. THE PDRN STATED IT IS WHERE THE PATIENT IS HANDLING THE SET AND COULD HAVE OVER TWISTED IT CAUSING THE CRACK. THE PATIENT WAS ADMITTED TO THE HOSPITAL. PD CULTURES WERE OBTAINED. THE PATIENT WAS DIAGNOSED WITH PERITONITIS. THE PATIENT INITIATED ANTIBIOTIC THERAPY WITH INTRAPERITONEAL (IP) CEFEPIME 1G DAILY AND IP VANCOMYCIN EVERY 3-4 DAYS WITH DOSING BASED ON THE VANCO TROUGH. THE LAST VANCO DOSE THE PATIENT RECEIVED WAS ON (B)(6) 2026 AT 2G. THE CULTURE WAS POSITIVE FOR SERRATIA LIQUEFACIENS. THE PATIENT WAS DISCHARGED ON (B)(6) 2026. THE CAUSE OF THE PERITONITIS EVENT IS SUSPECTED TO BE THE CRACKED CATHETER EXTENSION SET. THE SET WAS CHANGED DURING THE HOSPITALIZATION AND IS NOT AVAILABLE FOR RETURN TO THE MANUFACTURE

  Patient problems: Abdominal Pain; Peritonitis

  MAUDE report 25161567 ↗
• 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 ↗
• InjuryMar 23, 2026Fluid/Blood Leak

  A PERITONEAL DIALYSIS (PD) PATIENT CONTACTED FRESENIUS CUSTOMER SERVICE AND REPORTED THAT THEY WERE DIAGNOSED WITH PERITONITIS. THE PATIENT STATED THEY WERE TAKING ANTIBIOTICS. ADDITIONAL INFORMATION WAS OBTAINED THROUGH FOLLOW-UP WITH THE PATIENT AND THE PATIENT¿S PERITONEAL DIALYSIS REGISTERED NURSE (PDRN). THE PATIENT WENT TO THE HOSPITAL ON (B)(6) 2026 DUE TO ABDOMINAL PAIN, CLOUDY PD EFFLUENT, AND MALAISE. THE PATIENT WAS ADMITTED TO THE HOSPITAL. THE PATIENT WAS DIAGNOSED WITH PERITONITIS. A PD CULTURE WAS OBTAINED (UNKNOWN DATE). THE PATIENT WAS INITIATED ON ANTIBIOTIC THERAPY WITH INTRAPERITONEAL (IP) CEFAZOLIN DAILY FOR 2 WEEKS (DOSE NOT PROVIDED). THE CULTURE RESULTS STATE GRAM-POSITIVE COCCI. NO ORGANISM WAS DOCUMENTED IN THE CLINIC FILES. THE WHITE BLOOD CELL (WBC) COUNT WAS NOT AVAILABLE. THE PATIENT CONTINUED CONTINUOUS CYCLIC PD (CCPD) THERAPY DURING RECOVERY. THE PATIENT WAS DISCHARGED ON (B)(6) 2026. THE CAUSE OF THE PERITONITIS WAS A FLUID LEAK. THE PATIENT STATED THAT THEY ATTEMPTED TO CHANGE A BANDAGE AT THEIR PD CATHETER SITE (DATE UNKNOWN). THEY USED A PAIR OF SCISSORS AND ACCIDENTALLY CUT THE LINE ON THE PD CATHETER EXTENSION SET, PUTTING A HOLE IN THE LINE.

  Patient problems: Abdominal Pain; Malaise; Peritoneal effluent abnormal; Peritonitis

  MAUDE report 24670832 ↗
• InjuryFeb 12, 2026Disconnection

  A PERITONEAL DIALYSIS (PD) PATIENT WITH END STAGE RENAL DISEASE (ESRD) ON CONTINUOUS CYCLIC PERITONEAL DIALYSIS [CC(PD)] UTILIZING A LIBERTY CYCLER SET AND STAY SAFE/LUER LOCK CATHETER EXTENSION FOR RENAL REPLACEMENT THERAPY (RRT) SINCE (B)(6) 2025 REPORTED BEING HOSPITALIZED (DATE NOT PROVIDED) AND DIAGNOSED WITH PERITONITIS. DURING FOLLOW-UP, THE PATIENT¿S PD REGISTERED NURSE (PDRN) REPORTED THE PATIENT EXPERIENCED A DISCONNECTION (INCLUDING FLUID LEAK) BETWEEN THE LIBERTY CYCLER SET (PATIENT LINE) AND THE STAY SAFE/LUER LOCK CATHETER EXTENSION ON (B)(6) 2026. THE PDRN REPORTED THE LIKELY CAUSE OF THE SEPARATION WAS DUE TO ¿TUGGING,¿ HOWEVER THE DEFINITIVE CAUSE IS UNKNOWN. THE PDRN REPORTED THE PATIENT WAS HOSPITALIZED SHORTLY AFTER THE DISCONNECTION AND WAS DIAGNOSED WITH PERITONITIS. AS OF (B)(6) 2026 THE PATIENT REMAINED HOSPITALIZED AND NO FURTHER INFORMATION WAS AVAILABLE. SUBSEQUENT ATTEMPTS TO OBTAIN ADDITIONAL CLINICAL INFORMATION (E.G., PATIENT DEMOGRAPHICS, DISCHARGE SUMMARY, HOSPITAL RECORDS, ORGANISM, MEDICATION RECORDS, CAUSALITY) WERE UNSUCCESSFUL.

  Patient problems: Peritonitis

  MAUDE report 24329219 ↗
• MalfunctionFeb 11, 2026Fluid/Blood Leak

  A PERITONEAL DIALYSIS (PD) PATIENT REPORTED HAVING A CATHETER THAT BROKE. THE PATIENT SAID IT WASN'T A CONNECTOR ISSUE BUT DID NOT PROVIDE ANY FURTHER DETAILS. IN A FOLLOW UP, A FACILITY ADMINISTRATOR REPORTED THAT THERE WAS A DISCONNECTION AND FLUID LEAK DURING THE PATIENT'S PD TREATMENT. THE PATIENT AWOKE TO FLUID IN THE BED. IT WAS DISCOVERED THAT THE TRANSFER SET HAD DISCONNECTED FROM THE PATIENT'S CATHETER. IT WAS UNKNOWN WHEN OR HOW THE DISCONNECTION HAPPENED. THE PATIENT WENT TO THE CLINIC AND HAD A NEW TRANSFER SET PUT ONTO THE CATHETER. THE PATIENT WAS GIVEN PROPHYLACTIC ANTIBIOTICS. THE PATIENT DID NOT HAVE ANY HARM, INTERVENTION OR ADVERSE EVENT ASSOCIATED WITH THE DISCONNECTION. THE PATIENT IS USING THE SAME CYCLER. THE TRANSFER SET WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24314784 ↗
• InjuryJan 29, 2026Use of Device Problem

  A PERITONEAL DIALYSIS (PD) PATIENT CONTACTED FRESENIUS TECHNICAL SUPPORT FOR ISSUES OF SLOW DRAINS AND AN M31 ALARM RECEIVED DURING TREATMENT WHILE UTILIZING THE LIBERTY SELECT CYCLER ON (b)(6)2026. THE PATIENT STATED HAVING ATTEMPTED TO PUSH IN THE PIN FOR DISCONNECTION AND THAT THE PIN KEPT TWISTING. THE PATIENT REPORTED A FLUID LEAK FROM THE PATIENT LINE EXTENDER. THE PATIENT CANCELED THE TREATMENT AND WAS ADVISED TO CONTACT THE PERITONEAL DIALYSIS REGISTERED NURSE (PDRN). ADDITIONAL DETAILS WERE OBTAINED DURING A FOLLOW-UP CALL WITH THE PATIENT¿S PDRN. THE PDRN CLARIFIED THAT THE PATIENT HAD MISTAKENLY ATTEMPTED TO CHANGE OUT THE PD CATHETER EXTENSION SET. THE EXTENSION SET HAD BEEN DELIVERED TO THE PATIENT¿S HOME SO THAT THE PATIENT COULD BRING IT INTO THE PD CLINIC FOR THE PDRN TO CHANGE IT OUT. THE PATIENT WAS INSTRUCTED NOT TO CHANGE IT, HOWEVER; THE PATIENT ATTEMPTED TO CHANGE IT. THE PATIENT WAS INITIALLY STARTED ON PROPHYLACTIC ANTIBIOTICS (ROUTE, DRUG, DOSE, FREQUENCY, AND DURATION NOT PROVIDED). PD CULTURES WERE OBTAINED AND WERE POSITIVE FOR GROWTH (NO ORGANISM PROVIDED). THE PATIENT WAS DIAGNOSED WITH PERITONITIS. THE PATIENT WAS TREATED WITH A COMPLETED ANTIBIOTIC R

  Patient problems: Peritonitis

  MAUDE report 24215275 ↗
• 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 ↗
• MalfunctionDec 12, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT IS IN THE HOSPITAL AT THIS TIME. THE PATIENT WAS DOING DIALYSIS TREATMENT ON THE MACHINE AND A PIECE OF THE TERMINAL BROKE. THE PATIENT CALLED HIS NURSE AND ADVISED THEM OF WHAT HAPPENED AND THEY TOLD HIM TO GO TO THE HOSPITAL. THE PATIENT COMPLETED HIS DIALYSIS TREATMENT IN THE HOSPITAL. THE PATIENT STATED THE PIECE HAD BEEN REPLACED. FOLLOW-UP WITH THE PATIENT¿S PD REGISTERED NURSE (PDRN) REVEALED THE PATIENT PRESENTED TO THE EMERGENCY ROOM (ER) ON (B)(6) 2025 WHERE IT WAS DISCOVERED THE PATIENT¿S PD CATHETER (NOT A FRESENIUS PRODUCT) HAD SEPARATED FROM THE PATIENT¿S 18¿ FRESENIUS EXTENSION SET. THE PATIENT WAS SEEN BY THE SURGEON WHILE IN THE ER, AND A NEW EXTENSION SET WAS APPLIED. THE PATIENT WAS TREATED WITH A SINGLE PROPHYLACTIC DOSE OF AN UNSPECIFIED ANTIBIOTIC (DRUG, DOSE, ROUTE NOT PROVIDED) AND WAS ABLE TO COMPLETE CCPD THERAPY PRIOR TO BEING RELEASED HOME. THE PATIENT WAS NEVER FORMALLY HOSPITALIZED AND WAS IN THE ER <24 HOURS. PERITONEAL EFFLUENT FLUID CULTURES WERE COLLECTED AT THE OUTPATIENT HOME DIALYSIS CLINIC ON (B)(6) 2025 AND THE PRELIMINARY RESULTS AS OF (B)(6) 2025 WERE NEGATIVE. THE PDRN REPORTED THE EXA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23795009 ↗
• MalfunctionNov 28, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A PERITONEAL DIALYSIS (PD) NURSE REPORTED THAT A PD PATIENT SAID THERE WAS A LEAK ASSOCIATED WITH PD TREATMENT. PATIENT REPORTED BEING ALL WET, AND DISCOVERED THAT THE CATHETER EXTENSION WAS LEAKING. IN A FOLLOW UP, THE PATIENT'S PD NURSE VERIFIED THE FLUID LEAK EVENT AND SAID THE LEAK WAS COMING FROM THE EXTENSION SET. THERE WAS NO HARM, INTERVENTION OR ADVERSE EVENT ASSOCIATED WITH THE LEAK. THE PATIENT WAS PUT ON PROPHYLACTIC ANTIBIOTICS FOR PRECAUTION. THE PATIENT DID GET A NEW EXTENSION SET AND IS DOING TREATMENTS WITH NO FURTHER ISSUES. THE EXTENSION SET IS AVAILABLE TO RETURN FOR INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23673818 ↗
• MalfunctionOct 15, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT DISCOVERED A FLUID LEAK ON THE FLOOR DURING THEIR PD TREATMENT. THE PATIENT REPORTED RECEIVING AN AIR DETECTED IN CASSETTE ALARM DURING DWELL 3 OF 3 OF TREATMENT. THE WARNING OCCURRED MULTIPLE TIMES. THE PATIENT STATED THAT THE BAXTER BAG CAME LOOSE AND FLUID LEAKED ONTO THE FLOOR. THE PATIENT NOTED THAT THE BAXTER BAG WAS EMPTY. THE PATIENT ELECTED TO CONTINUE WITH TREATMENT UNLESS THE ALARM OCCURRED AGAIN. UPON FOLLOW UP, THE PATIENT STATED THAT THE ADAPTOR HAS A POOR DESIGN AND DOES NOT ATTACH TO THE BAXTER BAG PROPERLY. THE ADAPTOR FELL OFF DURING TREATMENT CAUSING THE BAXTER BAG TO LEAK ALL OVER HIS FLOOR. THE PATIENT WAS ABLE TO COMPLETE TREATMENT. THERE WAS NO PATIENT SERIOUS INJURY OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THIS EVENT. THE ADAPTOR WAS DISCARDED AND NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23302897 ↗

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