stay.safe® 050-95004Recalls & reported problems

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 00840861100781), received between Jul 11, 2017 and Feb 12, 2026 — classified as 28 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (17 reports).

1 FDA recall record name this device's identifier, 1 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, 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. Jan 23, 2024Class IOpen, Classified

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

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

Most reported problems

Recent adverse event reports

The 25 most recent of 43 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• MalfunctionSep 16, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A PERITONEAL DIALYSIS (PD) PATIENT CONTACT STATED SOMETHING BROKE OFF ON THE PATIENT'S PD CATHETER. THE PATIENT WAS NOT CONNECTED AT THE TIME OF THE CALL. UPON FOLLOW-UP, THE PERITONEAL DIALYSIS REGISTERED NURSE (PDRN) STATED DURING THE PATIENT'S TREATMENT, THE PATIENT WAS SITTING IN A CHAIR AND REPORTED FEELING FLUID ON THEIR STOMACH AND NOTICED THE CATHETER EXTENSION SET HAD BROKEN OFF OF THE PATIENT'S PD CATHETER. A FLUID LEAK WAS SUBSEQUENTLY NOTED FROM BETWEEN THE CATHETER EXTENSION AND THE CATHETER. THE PDRN STATED THE CONNECTION SITE DID NOT LEAK DURING SETUP BUT BEGAN LEAKING DURING AN UNKNOWN PHASE AND CYCLE OF TREATMENT. THE CAUSE OF DISCONNECTION WAS UNKNOWN. THE PDRN CONFIRMED THERE WERE NO ISSUES REPORTED WITH THE CYCLER OR CYCLER SET ITSELF, AND NO FLUID CAME INTO CONTACT WITH THE CYCLER. THE PDRN CONFIRMED THERE WERE NO SYMPTOMS, ADVERSE EVENTS, OR INJURIES REQUIRING MEDICAL INTERVENTION REQUIRED AS A RESULT OF THE REPORTED EVENT. THE PDRN STATED THE PATIENT CLAMPED OFF THE PD CATHETER AND CAME INTO THE CLINIC THAT SAME MORNING HAD HAD THE 12" EXTENSION SET REPLACED. THE PATIENT WAS PROVIDED PROPHYLACTIC MEDICATION AS PART OF PROTOCOL DUE TO THE FLUID LEAK (2G VANCOM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23065893 ↗
• InjuryApr 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NURSE REPORTED A 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 PERITONITIS ON (B)(6) 2025 (CAUSE UNKNOWN). DURING FOLLOW-UP, THE PATIENT¿S PDRN CONFIRMED THE PATIENT PRESENTED TO THE EMERGENCY ROOM ON (B)(6) 2025 DUE TO ABDOMINAL PAIN AND HAZY (CLOUDY) PERITONEAL EFFLUENT FLUID. A PERITONEAL EFFLUENT FLUID CULTURE AND CELL COUNT (WBC = 81 U/L, MONONUCLEAR CELLS = 24%, POLYMORPHS = 76%) WERE COLLECTED, AND THE PATIENT WAS FORMALLY ADMITTED. THE PATIENT WAS DIAGNOSED WITH PERITONITIS AND WAS INITIALLY TREATED WITH INTRAPERITONEAL (IP) VANCOMYCIN AND CEFTAZIDIME (DOSAGES, DURATIONS, FREQUENCIES WERE UNKNOWN). HOWEVER, THE PATIENT¿S PD CATHETER CULTURE RESULTS RETURNED POSITIVE FOR CANDIDA PARAPSILOSIS (FUNGAL INFECTION), AND THE NEPHROLOGIST ORDERED THE REMOVAL OF THE PATIENT¿S PD CATHETER, WHILE SIMULTANEOUSLY RECEIVING A HD CATHETER (NOT A FRESENIUS PRODUCT). THE PATIENT¿S IP ANTIBIOTICS WERE REPORTEDLY ALTERED ONCE THE CULTURE RESULTS RETURNED POSITIVE, HOWEVER THE DRUG(S), DOSE(S), FREQUENCY(S), AND DURATION(S) WERE

  Patient problems: Abdominal Pain; Fungal Infection; Peritoneal effluent abnormal; Peritonitis

  MAUDE report 21790939 ↗
• MalfunctionDec 23, 2024Fluid/Blood Leak; Fluid/Blood Leak

  A PERITONEAL DIALYSIS (PD) PATIENT REPORTED THE CYCLER PROMPTED WITH A MAKE SURE HEATER BAG IS ON THE HEATER TRAY MESSAGE DURING FILL 4 OF 4 OF TREATMENT. THE PATIENT WAS CONNECTED DURING THE INCIDENT. THE PATIENT STATED THE CATHETER EXTENSION FELL OF THE CATHETER. THE PATIENT CANCELLED THE TREATMENT AND WAS REFERRED TO THE PERITONEAL DIALYSIS REGISTERED NURSE (PDRN). ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT RECEIVED TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20999986 ↗
• InjuryDec 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY A PERITONEAL DIALYSIS (PD) NURSE THAT THIS PATIENT ON PD THERAPY WAS HOSPITALIZED (ON (B)(6) 2024) WITH PERITONITIS. THERE WERE NO REPORTED ALLEGATIONS THAT THE EVENT WAS RELATED TO ANY ISSUES WITH FRESENIUS PRODUCTS. IN AN ADDITIONAL FOLLOW-UP CALL, THE REPORTING NURSE STATED THAT ON 20/NOV/2024 THE PATIENT WAS SEEN IN THE OUTPATIENT PD CLINIC FOR A REGULARLY SCHEDULED VISIT. THE NURSE STATES WHEN THE PATIENT ARRIVED IN THE CLINIC IT WAS DISCOVERED THAT THE PATIENT HAD CUT THE TRANSFER SET ON THE PD CATHETER. ADDITIONALLY, THE PATIENT HAD SYMPTOMS OF ABDOMINAL PAIN. AS A RESULT, THE PATIENT HAD A PD CULTURE OBTAINED. PER THE NURSE, THE PD CULTURE WAS POSITIVE FOR GROWTH OF THE BACTERIA ESCHERICHIA COLI. THE PATIENT WAS INITIATED ON ANTIBIOTIC THERAPY WITH VANCOMYCIN AND FORTAZ INTRA-PERITONEAL (IP) FOR PERITONITIS. FURTHERMORE, THE TRANSFER SET ON THE PD CATHETER WAS CHANGED AND THE PATIENT WAS SENT HOME FROM THE PD CLINIC. HOWEVER, LATER THAT EVENING THE PATIENT WENT TO THE HOSPITAL DUE TO THE PATIENT¿S ABDOMINAL PAIN. THE NURSE STATED THE PATIENT WAS ADMITTED FOR PERITONITIS. THE PATIENT HAD THE PD CATHETER (NOT A FRESENIUS PRODUCT) REMOVED AND THE PATIENT WAS

  Patient problems: Abdominal Pain; Peritonitis

  MAUDE report 20894786 ↗
• InjuryNov 26, 2024Unintended Movement; Unintended Movement

  A PERITONEAL DIALYSIS (PD) NURSE REPORTED THAT A PATIENT ON PD HAD PERITONITIS. THE PATIENT WAS SEEN IN THE OUTPATIENT PD CLINIC FOR SYMPTOMS OF ABDOMINAL PAIN AND CLOUDY PD EFFLUENT. IT WAS REPORTED THAT DURING THE CLINIC VISIT IT WAS OBSERVED THAT THE BLUE ADAPTOR ON THE PATIENT¿S STAY SAFE EXTENSION SET WAS LOOSE. THE ADAPTOR WAS PLACED ON (B)(6) 2024 AND IS SCHEDULED TO BE CHANGED EVERY SIX MONTHS. PER THE PD NURSE, THE PATIENT HAD A PD CULTURE OBTAINED (THE SAME DAY) WHICH GREW COAGULASE NEGATIVE STAPHYLOCOCCUS, AND THE PATIENT WAS DIAGNOSED WITH PERITONITIS. THE PATIENT WAS TREATED WITH INTRA-PERITONEAL (IP) VANCOMYCIN AND CEFTAZIDIME (PER CLINIC PROTOCOL). THE PATIENT HAS RECOVERED FROM THE EVENT. PER THE NURSE, THE CAUSE OF THE PERITONITIS CANNOT BE FIRMLY ESTABLISHED. IT WAS REPORTED THAT THE PATIENT PERFORMS MANUAL PD EXCHANGES ONLY AND DOES NOT USE A FRESENIUS CYCLER FOR PD TREATMENT. THE NURSE STATED THE PATIENT DOES SEVERAL PD EXCHANGES A DAY AND THAT THIS REQUIRES THE PATIENT TO HANDLE CONNECTION ENDS FREQUENTLY. HOWEVER, IT IS UNKNOWN IF THE PATIENT HAD A BREACH IN ASEPTIC TECHNIQUE. FURTHERMORE, THE PD NURSE STATED IT IS UNKNOWN WHY THE STAY SAFE EXTENSION SET WAS L

  Patient problems: Abdominal Pain; Peritonitis

  MAUDE report 20785838 ↗
• InjurySep 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PERITONEAL DIALYSIS (PD) PATIENT REPORTED HE IS CURRENTLY COMPLETING IN-CENTER HEMODIALYSIS (HD) DUE TO A PERITONEAL INFECTION. ADDITIONAL INFORMATION WAS OBTAINED THROUGH FOLLOW-UP WITH THE PD CLINIC. ON (B)(6) 2024 THE PERITONEAL DIALYSIS REGISTERED NURSE (PDRN) WENT TO THE PATIENT¿S HOME FOR A SCHEDULED VISIT. DURING THE VISIT IT WAS NOTED THAT THE PATIENT HAD CLOUDY PD EFFLUENT BAGS. A PD EFFLUENT CULTURE WAS OBTAINED AND SENT FOR TESTING. THE PATIENT WAS DIAGNOSED WITH PERITONITIS. PER THE LAB, THE SAMPLE WAS TOO OLD TO PROCESS FOR A PATHOGEN. HOWEVER, THE RESULTS OF THE PATIENT¿S PD EFFLUENT WERE HAZY IN APPEARANCE, COLORLESS, RED BLOOD CELLS (RBC) 9MM3, WHITE BLOOD CELL (WBC) 868MM3, MONONUCLEAR CELLS 20%, POLYMORPHONUCLEAR CELLS 76%, AND EOSINOPHILS 4%. THE PATIENT WAS INITIATED ON ANTIBIOTICS WITH MEROPENEM 1G INTRAPERITONEAL (IP) DAILY FOR 21 DAYS AND VANCOMYCIN 2G IP EVERY 5 DAYS. MEROPENEM WAS USED IN PLACE OF ANCEF DUE TO A PATIENT ALLERGY. THE LEADING DOSE OF MEROPENEM AND VANCOMYCIN WERE ADMINISTERED IN THE CLINIC. THE CAUSE OF THE PERITONITIS WAS CONTAMINATION CAUSED BY THE PATIENT DROPPING THE END CAP ONTO THE FLOOR, WIPING IT OFF, AND REU

  Patient problems: Peritonitis; Sepsis

  MAUDE report 20240053 ↗
• MalfunctionJun 26, 2024Fluid/Blood Leak; Fluid/Blood Leak

  A PERITONEAL DIALYSIS (PD) PATIENT REPORTED A FLUID LEAK WAS DISCOVERED DURING FILL 1 OF 4 OF TREATMENT. THE PATIENT WAS CONNECTED DURING THE INCIDENT. FLUID WAS NOTED TO BE LEAKING FROM THE PATIENT CONNECTOR PUSH PIN. THE PATIENT EXPLAINED THAT A PORTION OF THE CATHETER CONNECTION HAD BROKEN. THE PATIENT WAS REQUESTED TO RESET UP THE CYCLER AT AT STEP 7 THE PATIENT EXPLAINED THAT A PART OF THE CONNECTION ON HER CATHETER WAS BROKEN, THE PATIENT WAS ADVISED TO CONTACT THE ON-CALL REGISTERED NURSE (RN). THERE WAS NO PATIENT INJURY NOTED DURING INTAKE. UPON FOLLOW-UP, THE PERITONEAL DIALYSIS REGISTERED NURSE (PDRN) STATED THE PATIENT USED A 12-INCH STAY SAFE LUER LOCK CATHETER EXTENSION WHICH DISCONNECTED FROM THE TUBING LINE AND LUER LOCK DURING AN UNKNOWN PHASE AND CYCLE OF TREATMENT AND CAUSED A FLUID LEAK TO OCCUR. THE PATIENT WAS ABLE TO CLAMP OFF THE LINE AND WAS UNABLE TO COMPLETE THEIR REMAINING TREATMENT ON THE NIGHT OF THE REPORTED EVENT. PER PDRN THE PATIENT WAS REQUESTED TO COME INTO THE CLINIC THE FOLLOWING MORNING AND WAS PRESCRIBED PROPHYLACTIC MEDICATION (VANCOMYCIN, 2G, INTRAPERITONEAL (IP) AS A PRECAUTION. PER PDRN THE PATIENT'S EXTENSION SET WAS REPLACED. THE PATIEN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19611945 ↗
• InjuryMay 14, 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 PERITONITIS. THE PATIENT CONTACT CONFIRMED THAT THE PATIENT HAS BEEN ADMINISTERED ANTIBIOTICS THROUGH A 6-HOUR DWELL IN ADDITION TO THE REGULARLY SCHEDULED PD TREATMENTS. UPON FOLLOW UP, THE PATIENT¿S PD NURSE STATED THAT THE PATIENT WAS SEEN IN THE OUTPATIENT PD CLINIC (ON 26/APR/2024) AFTER THE PATIENT CUT THE CAP OF THE TRANSFER SET OFF WITH SCISSORS. THE PATIENT HAD A PD CULTURE OBTAINED (THE SAME DAY) WHICH GREW THE BACTERIA STAPHYLOCOCCUS EPIDERMIS, AND THE PATIENT WAS DIAGNOSED WITH PERITONITIS. THE PATIENT WAS INITIATED ON INTRA-PERITONEAL (IP) VANCOMYCIN AND CEFTAZIDIME (PER CLINIC PROTOCOL). THE NURSE INDICATED THAT THE PATIENT¿S FAMILY IS CURRENTLY PERFORMING PD TREATMENT FOR THE PATIENT WITH THE SAME CYCLER. THE PATIENT IS RECOVERING FROM THE EVENT. THE PD NURSE CONFIRMED THE PATIENT DID NOT HAVE ANY FLUID LEAKS OR ISSUES WITH FRESENIUS PRODUCTS IN RELATION TO THE PERITONITIS. THE NURSE REPORTED THAT THE PATIENT BEEN DECLINING IN HER MENTAL STATUS. IN ADDITION TO THE PATIENT CUTTING THE TRANSFER SET WITH SCISSORS, THE PATIENT WAS NOT PERFORMING ASEPTIC TECHNIQUE WITH HER PD TREATMENTS. AS A RESUL

  Patient problems: Peritonitis

  MAUDE report 19315819 ↗
• MalfunctionJan 31, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT DISCOVERED A FLUID LEAK ON THE PATIENT LINE THEIR CYCLER SET DURING FILL 1 OF 4 OF PD TREATMENT. FLUID WAS NOT DISCOVERED IN THE PUMP MODULE AREA OR ON THE EXTERNAL OF THE CASSETTE. THE PATIENT DISCOVERED A HOLE IN THE TUBING WHERE A FEW DROPS OF LIQUID WAS FOUND. THERE WERE NO ALARMS OR WARNINGS PRIOR TO THE LEAK. THE PATIENT WAS ASSISTED WITH CANCELING TREATMENT. IT WAS REPORTED THAT AN ALTERNATE TREATMENT OPTION WAS AVAILABLE. UPON FOLLOW UP, THE PATIENT CONFIRMED THAT THERE WAS NO HOLE IN THE PATIENT LINE TUBING OR SOLUTION BAG. THE PATIENT CONFIRMED THAT THERE IS A CATHETER PLACED AND A STAY SAFE LUER LOCK CATHETER EXTENSION THAT IS PLACED BETWEEN THE CATHETER AND THE PATIENT LINE OF THE CYCLER SET. THE LEAK OCCURRED FROM A LOOSE CONNECTION BETWEEN THIS EXTENSION SET AND PATIENT LINE OF THE CYCLER SET. AFTER RESETTING UP WITH NEW SUPPLIES THE CONNECTION WAS TIGHTENED, AND TREATMENT COMPLETED SUCCESSFULLY. THE PATIENT DID NOT DEVELOP ANY SYMPTOMS, ADVERSE EVENTS, INJURIES, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THE REPORTED EVENT. THE PATIENT IS CONTINUING WITH PERITONEAL DIALYSIS ON THE CYCLER WITHOUT ISSUE AND WI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18615122 ↗
• InjurySep 6, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY A REGISTERED NURSE (RN) THAT THIS PATIENT ON PERITONEAL DIALYSIS (PD) THERAPY INCURRED A LEAK ON (B)(6)2023 WHEN THE CONNECTION BETWEEN THE EXTENSION SET AND THE PATIENT¿S PD CATHETER BECAME LOOSE WHILE THE PATIENT WAS SLEEPING. IN ADDITIONAL FOLLOW-UP WITH THE PATIENT¿S PD NURSE, THE EVENT WAS CONFIRMED. THE PATIENT HAD THE TRANSFER SET REPLACED IN THE PD CLINIC AND THE OLD SET WAS DISCARDED (LOT # UNAVAILABLE). FURTHERMORE, IT WAS DISCOVERED THAT ON (B)(6)2023, THE PATIENT WAS NOTED TO HAVE CLOUDY PD EFFLUENT DURING A ROUTINE PD CLINIC APPOINTMENT. AS A RESULT, THE PATIENT HAD A PD CULTURE OBTAINED WHICH GREW STREPTOCOCCUS CANIS AND COAGULASE NEGATIVE STAPHYLOCOCCUS. THE PATIENT WAS INITIATED ON ANTIBIOTIC THERAPY WITH DAILY CEFTAZIDIME AND VANCOMYCIN (PER CLINIC PROTOCOL) INTRA-PERITONEAL (IP) ON AN OUTPATIENT BASIS. PER THE NURSE, THE PATIENT IS RECOVERING FROM THE PERITONITIS EVENT AND CONTINUES PD THERAPY WITH THE SAME CYCLER AND NEW TRANSFER SET WITHOUT ANY FURTHER ISSUES. THE NURSE STATED IT IS UNKNOWN WHAT CAUSED THE LOOSE CONNECTION BETWEEN THE FRESENIUS TRANSFER SET AND THE PD CATHETER (NOT A FRESENIUS PRODUCT). HOWEVER, THE NURSE INDICATED THAT IT WAS

  Patient problems: Peritonitis

  MAUDE report 17691040 ↗
• InjurySep 6, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY A REGISTERED NURSE (RN) THAT THIS PATIENT ON PERITONEAL DIALYSIS (PD) THERAPY INCURRED A LEAK ON (B)(6) 2023 WHEN THE CONNECTION BETWEEN THE EXTENSION SET AND THE PATIENT¿S PD CATHETER BECAME LOOSE WHILE THE PATIENT WAS SLEEPING. IN ADDITIONAL FOLLOW-UP WITH THE PATIENT¿S PD NURSE, THE EVENT WAS CONFIRMED. THE PATIENT HAD THE TRANSFER SET REPLACED IN THE PD CLINIC AND THE OLD SET WAS DISCARDED (LOT # UNAVAILABLE). FURTHERMORE, IT WAS DISCOVERED THAT ON (B)(6) 2023, THE PATIENT WAS NOTED TO HAVE CLOUDY PD EFFLUENT DURING A ROUTINE PD CLINIC APPOINTMENT. AS A RESULT, THE PATIENT HAD A PD CULTURE OBTAINED WHICH GREW STREPTOCOCCUS CANIS AND COAGULASE NEGATIVE STAPHYLOCOCCUS. THE PATIENT WAS INITIATED ON ANTIBIOTIC THERAPY WITH DAILY CEFTAZIDIME AND VANCOMYCIN (PER CLINIC PROTOCOL) INTRA-PERITONEAL (IP) ON AN OUTPATIENT BASIS. PER THE NURSE, THE PATIENT IS RECOVERING FROM THE PERITONITIS EVENT AND CONTINUES PD THERAPY WITH THE SAME CYCLER AND NEW TRANSFER SET WITHOUT ANY FURTHER ISSUES. THE NURSE STATED IT IS UNKNOWN WHAT CAUSED THE LOOSE CONNECTION BETWEEN THE FRESENIUS TRANSFER SET AND THE PD CATHETER (NOT A FRESENIUS PRODUCT). HOWEVER, THE NURSE INDICATED THAT IT W

  Patient problems: Peritonitis

  MAUDE report 17691011 ↗
• InjuryJun 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PERITONEAL DIALYSIS (PD) PATIENT ON CONTINUOUS CYCLING PERITONEAL DIALYSIS (CCPD) FOR RENAL REPLACEMENT THERAPY (RRT) CONTACTED TECHNICAL SUPPORT FOR ASSISTANCE AND DURING THE CALL THE PATIENT REPORTED THAT THEY HAD PERITONITIS AND HAS BEEN TAKING MEDICATION FOR CONSTIPATION AND STATED THAT THEIR PERITONITIS COULD BE THE REASON FOR THE DRAINING SLOWLY ALARMS THAT THEY HAVE RECEIVED. UPON FOLLOW UP, THE PDRN STATED THE PATIENT WAS SEEN IN THE PD CLINIC ON (B)(6) 2023 TO HAVE THEIR PD CATHETER (NOT A FRESENIUS PRODUCT) FLUSHED DUE TO NOT BEING ABLE TO DRAIN. WHEN THE PATIENT ARRIVED, THE PDRN NOTED A CLOUDY PD EFFLUENT BAG AND NO CAP OR PIN ON THE EXTENSION SET. THE MISSING CAP RESULTED IN CONTAMINATION. A PD EFFLUENT CULTURE WAS OBTAINED. THE PATIENT WAS ADMINISTERED INITIAL ONE-TIME DOSES OF ANTIBIOTICS WITH INTRAPERITONEAL (IP) CEFEPIME 1G AND IP VANCOMYCIN 1750MG. THE CULTURE RESULTED POSITIVE FOR STAPHYLOCOCCUS EPIDERMIDIS, AND THE PATIENT¿S WHITE BLOOD CELL COUNT WAS 254. THE PATIENT¿S ANTIBIOTICS WERE CHANGED. THE PATIENT WAS TO CONTINUE WITH IP VANCOMYCIN 1750MG FOR 5 DOSES. THE CAUSE OF THE PATIENT¿S PERITONITIS WAS ATTRIBUTED TO CONTAMINATION FROM THE MISSING CAP AND PIN

  Patient problems: Constipation; Peritonitis

  MAUDE report 17119860 ↗
• InjuryJun 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PERITONEAL DIALYSIS (PD) PATIENT ON CONTINUOUS CYCLING PERITONEAL DIALYSIS (CCPD) FOR RENAL REPLACEMENT THERAPY (RRT) CONTACTED TECHNICAL SUPPORT FOR ASSISTANCE AND DURING THE CALL THE PATIENT REPORTED THAT THEY HAD PERITONITIS AND HAS BEEN TAKING MEDICATION FOR CONSTIPATION AND STATED THAT THEIR PERITONITIS COULD BE THE REASON FOR THE DRAINING SLOWLY ALARMS THAT THEY HAVE RECEIVED. UPON FOLLOW UP, THE PDRN STATED THE PATIENT WAS SEEN IN THE PD CLINIC ON (B)(6) 2023 TO HAVE THEIR PD CATHETER (NOT A FRESENIUS PRODUCT) FLUSHED DUE TO NOT BEING ABLE TO DRAIN. WHEN THE PATIENT ARRIVED, THE PDRN NOTED A CLOUDY PD EFFLUENT BAG AND NO CAP OR PIN ON THE EXTENSION SET. THE MISSING CAP RESULTED IN CONTAMINATION. A PD EFFLUENT CULTURE WAS OBTAINED. THE PATIENT WAS ADMINISTERED INITIAL ONE-TIME DOSES OF ANTIBIOTICS WITH INTRAPERITONEAL (IP) CEFEPIME 1G AND IP VANCOMYCIN 1750MG. THE CULTURE RESULTED POSITIVE FOR STAPHYLOCOCCUS EPIDERMIDIS, AND THE PATIENT¿S WHITE BLOOD CELL COUNT WAS 254. THE PATIENT¿S ANTIBIOTICS WERE CHANGED. THE PATIENT WAS TO CONTINUE WITH IP VANCOMYCIN 1750MG FOR 5 DOSES. THE CAUSE OF THE PATIENT¿S PERITONITIS WAS ATTRIBUTED TO CONTAMINATION FROM THE MISSING CAP AND PIN

  Patient problems: Constipation; Peritonitis

  MAUDE report 17119858 ↗
• InjuryMar 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PERITONEAL DIALYSIS (PD) PATIENT ON CONTINUOUS CYCLING PERITONEAL DIALYSIS (CCPD) FOR RENAL REPLACEMENT THERAPY (RRT) CONTACTED CUSTOMER SUPPORT AND REPORTED THEY GOT PERITONITIS WHILE ON THE MACHINE. UPON FOLLOW UP, THE PERITONEAL DIALYSIS REGISTERED NURSE (PDRN) STATED THAT THE PATIENT PRESENTED TO THE OUTPATIENT HOME DIALYSIS UNIT ON (B)(6) 2023 WITH COMPLAINTS OF ABDOMINAL PAIN AND CLOUDY PERITONEAL EFFLUENT FLUID. A PERITONEAL EFFLUENT FLUID CULTURE AND CELL COUNT (WBC = 3305 U/L, POLYMORPHS = 88%) WERE COLLECTED, AND THE PATIENT WAS DIAGNOSED WITH PERITONITIS. THE PATIENT WAS TREATED AS AN OUTPATIENT WITH INTRAPERITONEAL (IP) VANCOMYCIN (PER VANCOMYCIN LEVEL) AND CEFTAZIDIME 1500 MG DAILY FOR 14-21 DAYS. THE PATIENT¿S PERITONEAL EFFLUENT CULTURE RESULT RETURNED NEGATIVE FOR GROWTH ON (B)(6) 2023, AND THE PATIENT¿S ANTIBIOTICS WERE CONTINUED. THE PATIENT CONTINUES TO UNDERGO CONTINUOUS CYCLIC PD (CCPD) UTILIZING THE SAME LIBERTY SELECT CYCLER AND IS RECOVERING FROM THE SERIOUS ADVERSE EVENTS. THE PDRN ATTRIBUTED CAUSALITY TO A DISCONNECTION EVENT, WHEN THE PATIENT¿S PD CATHETER EXTENSION SET DISCONNECTED FROM THE LIBERTY CYCLER SET DUE TO INADEQUATE TIGHTENING. THE PATIENT R

  Patient problems: Abdominal Pain; Peritonitis

  MAUDE report 16491560 ↗
• InjuryMar 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PERITONEAL DIALYSIS (PD) PATIENT ON CONTINUOUS CYCLING PERITONEAL DIALYSIS (CCPD) FOR RENAL REPLACEMENT THERAPY (RRT) CONTACTED CUSTOMER SUPPORT AND REPORTED THEY GOT PERITONITIS WHILE ON THE MACHINE. UPON FOLLOW UP, THE PERITONEAL DIALYSIS REGISTERED NURSE (PDRN) STATED THAT THE PATIENT PRESENTED TO THE OUTPATIENT HOME DIALYSIS UNIT ON (B)(6) 2023 WITH COMPLAINTS OF ABDOMINAL PAIN AND CLOUDY PERITONEAL EFFLUENT FLUID. A PERITONEAL EFFLUENT FLUID CULTURE AND CELL COUNT (WBC = 3305 U/L, POLYMORPHS = 88%) WERE COLLECTED, AND THE PATIENT WAS DIAGNOSED WITH PERITONITIS. THE PATIENT WAS TREATED AS AN OUTPATIENT WITH INTRAPERITONEAL (IP) VANCOMYCIN (PER VANCOMYCIN LEVEL) AND CEFTAZIDIME 1500 MG DAILY FOR 14-21 DAYS. THE PATIENT¿S PERITONEAL EFFLUENT CULTURE RESULT RETURNED NEGATIVE FOR GROWTH ON (B)(6) 2023, AND THE PATIENT¿S ANTIBIOTICS WERE CONTINUED. THE PATIENT CONTINUES TO UNDERGO CONTINUOUS CYCLIC PD (CCPD) UTILIZING THE SAME LIBERTY SELECT CYCLER AND IS RECOVERING FROM THE SERIOUS ADVERSE EVENTS. THE PDRN ATTRIBUTED CAUSALITY TO A DISCONNECTION EVENT, WHEN THE PATIENT¿S PD CATHETER EXTENSION SET DISCONNECTED FROM THE LIBERTY CYCLER SET DUE TO INADEQUATE TIGHTENING. THE PATIENT R

  Patient problems: Abdominal Pain; Peritonitis

  MAUDE report 16491535 ↗
• MalfunctionFeb 22, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT DISCOVERED A FLUID LEAK AS A RESULT OF THEIR STAY SAFE CONNECTOR BECOMING UNDONE DURING PD TREATMENT. THE PATIENT REPORTED RECEIVING A NOTICE: DRAINING SLOWLY MESSAGE DURING DRAIN 2 OF 4 OF TREATMENT AND THE TREATMENT WAS CANCELLED. IT IS UNKNOWN AT WHICH POINT IN THERAPY THE LEAK MAY HAVE BEGUN. THE CAUSE OF THE LEAK IS UNKNOWN. THE PATIENT WAS ASSISTED WITH CANCELLING THE TREATMENT AND WAS ADVISED TO FOLLOW UP WITH THEIR PERITONEAL DIALYSIS REGISTERED NURSE (PDRN). IT WAS NOT REPORTED IF AN ALTERNATE TREATMENT OPTION WAS AVAILABLE. UPON FOLLOW UP, THE PDRN STATED THE PATIENT IS TRAINED ON PERFORMING STAT DRAINS, AS WELL AS MANUAL PERITONEAL DIALYSIS THERAPY IF NEEDED, AND CONFIRMED THAT THE PATIENT WAS NOT ABLE TO COMPLETE PERITONEAL DIALYSIS TREATMENT ON THE DAY OF THE REPORTED EVENT. THE PATIENT DID NOT DEVELOP ANY SYMPTOMS, ADVERSE EVENTS, INJURIES, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THE REPORTED EVENT. PDRN CONFIRMED THAT THE TUBING THE PATIENT CONNECTS TO THE EXTENSION SET BECAME DISCONNECTED DURING TREATMENT. THE EXTENSION SET WAS DISCARDED AND IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16418753 ↗
• InjuryJan 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2023 THIS MALE PERITONEAL DIALYSIS (PD) PATIENT CONTACTED FRESENIUS CUSTOMER SERVICE. THE PATIENT STATED THAT HE THOUGHT HE HAD ORDERED STAY SAFE CAPS LAST YEAR FOR WHEN HE TRAVELED. HOWEVER, HE ENDED UP IN THE HOSPITAL FOR ELEVEN DAYS WITH A DIAGNOSIS OF PERITONITIS DUE TO NO CAPS. CUSTOMER SERVICE WAS UNABLE TO SUBSTANTIATE THE REPORT OF ORDERING CAPS. ADDITIONAL INFORMATION WAS OBTAINED THROUGH FOLLOW-UP WITH THE PATIENT¿S PERITONEAL DIALYSIS REGISTERED NURSE (PDRN). THE PATIENT WAS TRAVELING WHEN HE WENT TO THE HOSPITAL ON (B)(6) 2022 WITH REPORTS OF ABDOMINAL PAIN AND CLOUDY PD EFFLUENT. THE PATIENT WAS ADMITTED TO THE HOSPITAL. A PD EFFLUENT CULTURE WAS OBTAINED, AND THE PATIENT WAS INITIATED ON ANTIBIOTIC THERAPY. THE PATIENT WAS ADMINISTERED INTRAPERITONEAL (IP) VANCOMYCIN (DOSE, FREQUENCY, AND DURATION UNKNOWN). THE PD CULTURE RESULTED IN NO GROWTH. THE PATIENT WAS DISCHARGED ON (B)(6) 2022. UPON DISCHARGE, THE PATIENT¿S ANTIBIOTIC THERAPY WAS ADJUSTED. THE VANCOMYCIN WAS DISCONTINUED, AND THE PATIENT WAS PRESCRIBED IP CEFTAZIDIME DAILY FOR 12 DAYS (DOSE UNKNOWN). THE SUSPECTED CAUSE OF THE PERITONITIS IS THE PATIENT NOT HAVING THE STAY SAFE CAP FOR THE STAY SAFE

  Patient problems: Abdominal Pain; Peritonitis

  MAUDE report 16242489 ↗
• InjuryJan 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2023 THIS MALE PERITONEAL DIALYSIS (PD) PATIENT CONTACTED FRESENIUS CUSTOMER SERVICE. THE PATIENT STATED THAT HE THOUGHT HE HAD ORDERED STAY SAFE CAPS LAST YEAR FOR WHEN HE TRAVELED. HOWEVER, HE ENDED UP IN THE HOSPITAL FOR ELEVEN DAYS WITH A DIAGNOSIS OF PERITONITIS DUE TO NO CAPS. CUSTOMER SERVICE WAS UNABLE TO SUBSTANTIATE THE REPORT OF ORDERING CAPS. ADDITIONAL INFORMATION WAS OBTAINED THROUGH FOLLOW-UP WITH THE PATIENT¿S PERITONEAL DIALYSIS REGISTERED NURSE (PDRN). THE PATIENT WAS TRAVELING WHEN HE WENT TO THE HOSPITAL ON (B)(6) 2022 WITH REPORTS OF ABDOMINAL PAIN AND CLOUDY PD EFFLUENT. THE PATIENT WAS ADMITTED TO THE HOSPITAL. A PD EFFLUENT CULTURE WAS OBTAINED, AND THE PATIENT WAS INITIATED ON ANTIBIOTIC THERAPY. THE PATIENT WAS ADMINISTERED INTRAPERITONEAL (IP) VANCOMYCIN (DOSE, FREQUENCY, AND DURATION UNKNOWN). THE PD CULTURE RESULTED IN NO GROWTH. THE PATIENT WAS DISCHARGED ON (B)(6) 2022. UPON DISCHARGE, THE PATIENT¿S ANTIBIOTIC THERAPY WAS ADJUSTED. THE VANCOMYCIN WAS DISCONTINUED, AND THE PATIENT WAS PRESCRIBED IP CEFTAZIDIME DAILY FOR 12 DAYS (DOSE UNKNOWN). THE SUSPECTED CAUSE OF THE PERITONITIS IS THE PATIENT NOT HAVING THE STAY SAFE CAP FOR THE STAY SAFE

  Patient problems: Abdominal Pain; Peritonitis

  MAUDE report 16242484 ↗
• InjuryOct 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PERITONEAL DIALYSIS (PD) PATIENT CONTACTED FRESENIUS TECHNICAL SUPPORT DURING DWELL 3 OF 6 OF TREATMENT ON THE LIBERTY SELECT CYCLER TO REPORT THAT A HOLE WAS FOUND IN THEIR CATHETER LINE AND REQUEST ASSISTANCE WITH CANCELING TREATMENT TO GO TO THE EMERGENCY ROOM (ER). FRESENIUS TECHNICAL SUPPORT ASSISTED THE PATIENT WITH CANCELING TREATMENT ON THE CYCLER. UPON INITIAL FOLLOW-UP IT WAS REPORTED THAT THE PATIENT IS TEMPORARILY COMPLETING HEMODIALYSIS FOR APPROXIMATELY TWO WEEKS. NO ADDITIONAL INFORMATION WAS KNOWN RELATED TO THE ER VISIT OR ANY MEDICAL INTERVENTION THAT COULD HAVE BEEN PROVIDED TO THE PATIENT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE UNSUCCESSFUL.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 15670622 ↗
• InjuryOct 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PERITONEAL DIALYSIS (PD) PATIENT CONTACTED FRESENIUS TECHNICAL SUPPORT DURING DWELL 3 OF 6 OF TREATMENT ON THE LIBERTY SELECT CYCLER TO REPORT THAT A HOLE WAS FOUND IN THEIR CATHETER LINE AND REQUEST ASSISTANCE WITH CANCELING TREATMENT TO GO TO THE EMERGENCY ROOM (ER). FRESENIUS TECHNICAL SUPPORT ASSISTED THE PATIENT WITH CANCELING TREATMENT ON THE CYCLER. UPON INITIAL FOLLOW-UP IT WAS REPORTED THAT THE PATIENT IS TEMPORARILY COMPLETING HEMODIALYSIS FOR APPROXIMATELY TWO WEEKS. NO ADDITIONAL INFORMATION WAS KNOWN RELATED TO THE ER VISIT OR ANY MEDICAL INTERVENTION THAT COULD HAVE BEEN PROVIDED TO THE PATIENT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE UNSUCCESSFUL.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 15670458 ↗
• InjuryJul 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE INFORMATION IN THE COMPLAINT FILE HAS BEEN REVIEWED. ON (B)(6) 2022, DURING A FOLLOW UP, A PERITONEAL DIALYSIS REGISTERED NURSE [(PD)RN] REPORTED THIS PATIENT ON CONTINUOUS CYCLIC PD (CCPD) THERAPY ON THE LIBERTY SELECT CYCLER EXPERIENCED PERITONITIS. THERE WAS NO SPECIFIC ALLEGATION THIS ADVERSE EVENT WAS DUE TO A DEFICIENCY OR MALFUNCTION OF ANY FRESENIUS PRODUCT(S) OR DEVICE(S) IN THE INITIAL REPORTING. UPON FOLLOW UP WITH THE PATIENT¿S PDRN, IT WAS REPORTED THIS PATIENT PRESENTED TO THE OUTPATIENT CLINIC ON (B)(6) 2022 WITH ABDOMINAL PAIN AND CLOUDY PERITONEAL EFFLUENT FLUID. PERITONEAL EFFLUENT FLUID CULTURES AND A WHITE BLOOD CELL (WBC) COUNT TAKEN IN THE OUTPATIENT CLINIC ON (B)(6) 2022 PRESENTED WITH STAPHYLOCOCCUS EPIDERMIDIS AND A WBC COUNT OF 182/MM3. THE PATIENT WAS DIAGNOSED WITH PERITONITIS DUE TO TOUCH CONTAMINATION DURING CCPD THERAPY ON THE LIBERTY SELECT CYCLER AT HOME. IT WAS EXPLAINED THE PATIENT HAS POOR EYESIGHT, SO A CARETAKER TYPICALLY ASSISTS THE PATIENT WITH PD THERAPY. THE PATIENT¿S CARETAKER WAS UNAVAILABLE FOR A FEW PD TREATMENTS AND THE PATIENT DID NOT USE HIS ORGANIZER WHICH CAUSED CONTAMINATION TO HIS EXTENSION SET AND PATIENT LINE. THE PATIENT W

  Patient problems: Abdominal Pain; Peritonitis

  MAUDE report 15084765 ↗
• InjuryJul 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE INFORMATION IN THE COMPLAINT FILE HAS BEEN REVIEWED. ON (B)(6) 2022, DURING A FOLLOW UP, A PERITONEAL DIALYSIS REGISTERED NURSE [(PD)RN] REPORTED THIS PATIENT ON CONTINUOUS CYCLIC PD (CCPD) THERAPY ON THE LIBERTY SELECT CYCLER EXPERIENCED PERITONITIS. THERE WAS NO SPECIFIC ALLEGATION THIS ADVERSE EVENT WAS DUE TO A DEFICIENCY OR MALFUNCTION OF ANY FRESENIUS PRODUCT(S) OR DEVICE(S) IN THE INITIAL REPORTING. UPON FOLLOW UP WITH THE PATIENT¿S PDRN, IT WAS REPORTED THIS PATIENT PRESENTED TO THE OUTPATIENT CLINIC ON (B)(6) 2022 WITH ABDOMINAL PAIN AND CLOUDY PERITONEAL EFFLUENT FLUID. PERITONEAL EFFLUENT FLUID CULTURES AND A WHITE BLOOD CELL (WBC) COUNT TAKEN IN THE OUTPATIENT CLINIC ON (B)(6) 2022 PRESENTED WITH STAPHYLOCOCCUS EPIDERMIDIS AND A WBC COUNT OF 182/MM3. THE PATIENT WAS DIAGNOSED WITH PERITONITIS DUE TO TOUCH CONTAMINATION DURING CCPD THERAPY ON THE LIBERTY SELECT CYCLER AT HOME. IT WAS EXPLAINED THE PATIENT HAS POOR EYESIGHT, SO A CARETAKER TYPICALLY ASSISTS THE PATIENT WITH PD THERAPY. THE PATIENT¿S CARETAKER WAS UNAVAILABLE FOR A FEW PD TREATMENTS AND THE PATIENT DID NOT USE HIS ORGANIZER WHICH CAUSED CONTAMINATION TO HIS EXTENSION SET AND PATIENT LINE. THE PATIENT W

  Patient problems: Abdominal Pain; Peritonitis

  MAUDE report 15084699 ↗
• MalfunctionAug 27, 2021Fluid/Blood Leak; Fluid/Blood Leak

  A PERITONEAL DIALYSIS (PD) PATIENT¿S CONTACT REPORTED TO FRESENIUS TECHNICAL SUPPORT (TS) THAT A FLUID LEAK OCCURRED DURING THE PATIENT¿S DIALYSIS TREATMENT. THE FLUID LEAK WAS DISCOVERED IN DRAIN 2 OF 5. THE PATIENT CONTACT STATED FLUID LEAKED FROM THE PATIENT LINE AND INDICATED THAT IT WAS ONLY WET NEAR THE PATIENT CONNECTION. THIS WAS CONFIRMED UPON FOLLOW-UP WITH THE PATIENT CONTACT. THE FLUID LEAK WAS REPORTEDLY COMING FROM THE CONNECTION POINT OF THE PATIENT LINE TO THE CATHETER EXTENSION. THE PATIENT CONTACT WAS UNSURE WHAT CAUSED THE LEAK, BUT THEY WOULD NOT RULE OUT USE ERROR. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THE FLUID LEAK, NOR DID THEY REQUIRE ANY MEDICAL INTERVENTION. THE PATIENT¿S PD CLINIC WAS INFORMED OF THE EVENT, AND AS A PRECAUTION, THE PATIENT WAS GIVEN A ONE-TIME DOSE OF VANCOMYCIN. THE PATIENT CONTACT CONFIRMED THE PATIENT DID NOT DEVELOP ANY SYMPTOMS AND REPORTED THAT THE PATIENT¿S EFFLUENT HAD REMAINED CLEAR. THE PATIENT CONTACT COULD NOT RECALL IF THE PATIENT COMPLETED TREATMENT ON THE EVENT DATE. IT WAS CONFIRMED THAT THE PATIENT WAS TRAINED ON PERFORMING MANUAL PD THERAPY, AS WELL AS STAT DRAINS IF NECESSARY. THE LOT NUMBER FOR THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12378983 ↗