stay.safe® 050-95005Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 00840861100798), received between Mar 21, 2018 and Jul 17, 2026 — classified as 12 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (22 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-1326-2024 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 34 reports, in the reporter's own words as published by the FDA.

• 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 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionAug 12, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A PERITONEAL DIALYSIS (PD) PATIENT REPORTED A FLUID LEAK WAS DISCOVERED DURING DWELL 1 OF 4 OF TREATMENT. THE PATIENT WAS CONNECTED DURING THE INCIDENT. FLUID LEAKED FROM THE PATIENT CATHETER LINE. THERE WERE NO ALARMS OR WARNINGS PRIOR TO OR AFTER THE LEAK. FLUID WAS NOT DISCOVERED IN THE PUMP MODULE AREA OR ON THE EXTERNAL OF THE CASSETTE. THE PATIENT WAS ASSISTED WITH CANCELLING TREATMENT. THE PATIENT WAS TO CONTACT THE PERITONEAL DIALYSIS REGISTERED NURSE (PDRN). THERE WAS NO PATIENT INJURY NOTED AT INTAKE. UPON FOLLOW-UP, THE PDRN CONFIRMED THE REPORTED EVENT. THE PDRN STATED THE PATIENT USED A 18-INCH STAY SAFE LUER LOCK CATHETER EXTENSION WHICH BEGAN LEAKING FROM A PINHOLE IN THE TUBING LINE NEAR THE CONNECTION POINT TO THE PATIENT LINE OF THE CYCLER SET DURING AN UNKNOWN PHASE AND CYCLE OF TREATMENT. IT IS UNKNOWN HOW THE PINHOLE OR LEAK OCCURRED. THE PATIENT CLAMPED OFF THE EXTENSION SET AND DISCONTINUED TREATMENT FOR THE EVENING, AND CAME INTO THE CLINIC THE FOLLOWING MORNING FOR FLUID CULTURE AND REPLACEMENT OF THE CATHETER EXTENSIONS SET. PER PDRN THE PATIENT WAS PRESCRIBED PROPHYLACTIC MEDICATION (VANCOMYCIN, 2G, INTRAPERITONEAL (IP) AS A PRECAUTION. THE PATIENT FLUID

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22784221 ↗
• InjuryApr 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) PRESENTED TO THE OUTPATIENT HOME DIALYSIS CLINIC (OHDC) ON (B)(6) 2025 AFTER HIS STAY SAFE CATHETER EXTENSION SET DISLODGED. THE PD REGISTERED NURSE (PDRN) CONFIRMED THE PATIENT PRESENTED TO THE OHDC AFTER HIS STAY SAFE CATHETER EXTENSION SET BECAME CAUGHT IN HIS SHOWER CHAIR WHILE SHOWERING. THE PATIENT¿S STAY SAFE CATHETER EXTENSION SET BECAME SEVERED FROM THE ADAPTER, AFTER WHICH THE PATIENT CLAMPED THE PD CATHETER (NOT A FRESENIUS PRODUCT) TUBING AND WENT TO THE OHDC. THE PDRN REPORTED THAT THE PATIENT ARRIVED WITH A REDDENED PD CATHETER EXIT SITE (SKIN INTACT) AND NO DRESSING COVERING THE PD CATHETER/EXIT SITE. AS A RESULT, PERITONEAL EFFLUENT FLUID CULTURES WERE OBTAINED, AND THE PATIENT WAS TREATED PROPHYLACTICALLY WITH INTRAPERITONEAL (IP) VANCOMYCIN 2000 MG AND IP CEFEPIME 2000 MG. IT APPEARS THE PATIENT¿S PRELIMINARY PERITONEAL EFFLUENT FLUID CULTURE RETURNED POSITIVE FOR ENTEROCOCCUS FAECALIS ON (B)(6) 2025, AND THE PATIENT WAS HOSPITALIZED FOR PERITONITIS. IT I

  Patient problems: Peritonitis

  MAUDE report 21777702 ↗
• InjuryNov 12, 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 ADMITTED TO THE HOSPITAL DUE TO ABDOMINAL DISTENSION. UPON FOLLOW UP WITH THE PATIENT¿S PDRN, IT WAS REPORTED THIS PATIENT WAS HOSPITALIZED ON (B)(6) 2024 FOR FLUID RETENTION DUE TO NONCOMPLIANCE TO PD ORDERS. IT WAS EXPLAINED THE PATIENT BROKE THE BLUE CONNECTOR FROM HIS EXTENSION SET INTO HIS STAY-SAFE ORGANIZER WHEN APPLYING TOO MUCH FORCE AND NEGLECTED TO REPORT THIS EVENT TO THE OUTPATIENT CLINIC. AS A RESULT, THE PATIENT SKIPPED MULTIPLE PD TREATMENTS AND EXPERIENCED FLUID RETENTION WITH ABDOMINAL DISTENTION. IT WAS AFFIRMED THE PATIENT WAS TRAINED ON MANUAL EXCHANGES AND HAD THE APPROPRIATE SUPPLIES AT THE TIME OF THIS EVENT. THE PATIENT HAS BEEN ABLE TO UNDERGO CCPD THERAPY ON A HOSPITAL PROVIDED CYCLER (UNKNOWN BRAND AND MODEL) FOR THE DURATION OF THE ADMISSION. THE PATIENT WAS ALSO DIAGNOSED WITH HYPERGLYCEMIA DURING THIS ADMISSION THAT WAS ATTRIBUTED TO COMORBIDITIES UNRELATED TO PD THERAPY OR THE USE OF ANY FRESENIUS PRODUCT(S) OR DEVICE(S). ADDITIONALLY, IT WAS CONFIRMED THE PATIENT¿S FLUID RETENTION, ABDOMINAL DISTENTION AND ASSOCIATED HOSPITALIZATION WERE NOT DUE TO A DEFICIENCY OR MALFUNCTION OF ANY FRESENI

  Patient problems: Abdominal Distention; Hyperglycemia; Hypervolemia

  MAUDE report 20666824 ↗
• MalfunctionSep 23, 2024Disconnection; Disconnection

  A PERITONEAL DIALYSIS (PD) PATIENT'S CAREGIVER REPORTED THAT DURING THE PATIENT'S PD TREATMENT THERE WAS A DISCONNECTION. DURING FILL 1 OF 8 PART OF THE TUBING "POPPED OFF' FROM THE CATHETER LINE. IN A FOLLOW UP, THE PATIENT'S PD NURSE CLARIFIED THE EVENT. THE NURSE SAID THAT THE EXTENSION SET CONNECTOR CAME LOOSE FROM THE EXTENSION SET TUBING. THE PATIENT WAS ABLE TO COME TO THE CLINIC AND HAD A NEW EXTENSION SET CONNECTED. THERE WAS NO HARM, INTERVENTION OR ADVERSE EVENT. THE EXTENSION SET IS NOT AVAILABLE TO RETURN AS A SAMPLE PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20285233 ↗
• MalfunctionJun 19, 2024Fluid/Blood Leak; Fluid/Blood Leak

  A PERITONEAL DIALYSIS (PD) PATIENT STATED THE END OF THE CATHETER FELL OFF AND WAS NOW OPEN DURING DWELL 3 OF 4 OF TREATMENT. THE PATIENT WAS NOT CONNECTED AT THE TIME OF THE CALL AND THE REPORTED ISSUE WAS NOT A RESULT OF THE SUPPLIES. THE PATIENT KNEW HOW TO PERFORM MANUALS. THE PATIENT WAS RECOMMENDED GETTING IN TOUCH WITH THE PERITONEAL DIALYSIS REGISTERED NURSE (PDRN) OR GOING TO THE HOSPITAL. THE PATIENT CANCELLED TREATMENT ON THEIR OWN. UPON FOLLOW-UP, THE PDRN STATED THE CATHETER EXTENSION SET DISCONNECTED OFF FROM THE PATIENT'S PD CATHETER DURING TREATMENT, CAUSING A FLUID LEAK TO OCCUR. THE PDRN SUSPECTED THE PATIENT MAY HAVE INADVERTENTLY TWISTED OFF THE EXTENSION SET AT THE LUER-LOCK END FROM THE PD CATHETER ADAPTER BUT WAS UNABLE TO CONFIRM THIS. THE PATIENT IMMEDIATELY CLAMPED OFF THE EXTENSION SET AND PD CATHETER AND CONTACTED THE PDRN, WHO ADVISED FOR THE PATIENT TO GO TO THE EMERGENCY ROOM AND RECEIVED A REPLACEMENT BAXTER EXTENSION SET IN ORDER TO DIALYZE WHILE AT THE HOSPITAL. THE PATIENT WAS PRESCRIBED ANTIBIOTICS VIA VANCOMYCIN WHILE AT THE ER (ROUTE, DOSE, FREQUENCY, AND DURATION NOT PROVIDED). THE PATIENT WAS NOT FORMALLY ADMITTED TO THE HOSPITAL AND RETURNED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19566948 ↗
• InjuryJun 11, 2024Crack; Adverse Event Without Identified Device or Use Problem; Crack; Adverse Event Without Identified Device or Use Problem

  ON 3/JUN/2024 DURING FOLLOW-UP, FRESENIUS BECAME AWARE THIS PATIENT WITH END STAGE RENAL DISEASE (ESRD) ON CONTINUOUS CYCLIC PERITONEAL DIALYSIS [CC(PD)] UTILIZING A STAY SAFE CATHETER EXTENSION SET FOR RENAL REPLACEMENT THERAPY (RRT) CONTRACTED PERITONITIS AFTER DISCOVERING A CRACKED STAY SAFE CATHETER EXTENSION. NO ADDITIONAL INFORMATION WAS PROVIDED DURING INTAKE. FOLLOW-UP WITH THE PATIENT¿S PRIMARY PD REGISTERED NURSE (PDRN) REVEALED THE PATIENT WAS UNDERGOING CCPD ON 26/MAY/2024, WHEN HE NOTICED THE BED WAS WET. IT WAS DISCOVERED THE PD CATHETERS¿ (NOT A FRESENIUS PRODUCT) STAY SAFE EXTENSION SET HAD CRACKED AND WAS LEAKING DIALYSATE (REPLACED 27/MAY/2024). THE CAUSE OF THE CRACKED EXTENSION SET REMAINS UNKNOWN. THE PATIENT CALLED THE ON-CALL PDRN WHO INSTRUCTED THE PATIENT TO WRAP THE EXTENSION SET IN STERILE GAUZE AND REPORT TO THE CLINIC ON MONDAY 27/MAY/2024. THE PATIENT PRESENTED TO THE OUTPATIENT HOME DIALYSIS CLINIC WITH CLOUDY PERITONEAL EFFLUENT FLUID AND A PERITONEAL EFFLUENT FLUID CULTURE AND CELL COUNT WERE OBTAINED (WBC CELL COUNT = 2278 U/L, POLYMORPHS = 79%) AND THE PATIENT WAS DIAGNOSED WITH PERITONITIS. THE PATIENT WAS TREATED WITH INTRAPERITONEAL (IP) CEFEPI

  Patient problems: Abdominal Pain; Cramp(s) /Muscle Spasm(s); High Blood Pressure/ Hypertension; Peritonitis

  MAUDE report 19513644 ↗
• InjuryJun 11, 2024Crack; Adverse Event Without Identified Device or Use Problem; Crack; Adverse Event Without Identified Device or Use Problem

  ON 3/JUN/2024 DURING FOLLOW-UP, FRESENIUS BECAME AWARE THIS PATIENT WITH END STAGE RENAL DISEASE (ESRD) ON CONTINUOUS CYCLIC PERITONEAL DIALYSIS [CC(PD)] UTILIZING A STAY SAFE CATHETER EXTENSION SET FOR RENAL REPLACEMENT THERAPY (RRT) CONTRACTED PERITONITIS AFTER DISCOVERING A CRACKED STAY SAFE CATHETER EXTENSION. NO ADDITIONAL INFORMATION WAS PROVIDED DURING INTAKE. FOLLOW-UP WITH THE PATIENT¿S PRIMARY PD REGISTERED NURSE (PDRN) REVEALED THE PATIENT WAS UNDERGOING CCPD ON (B)(6) 2024, WHEN HE NOTICED THE BED WAS WET. IT WAS DISCOVERED THE PD CATHETERS¿ (NOT A FRESENIUS PRODUCT) STAY SAFE EXTENSION SET HAD CRACKED AND WAS LEAKING DIALYSATE (REPLACED (B)(6) 2024). THE CAUSE OF THE CRACKED EXTENSION SET REMAINS UNKNOWN. THE PATIENT CALLED THE ON-CALL PDRN WHO INSTRUCTED THE PATIENT TO WRAP THE EXTENSION SET IN STERILE GAUZE AND REPORT TO THE CLINIC ON MONDAY (B)(6) 2024. THE PATIENT PRESENTED TO THE OUTPATIENT HOME DIALYSIS CLINIC WITH CLOUDY PERITONEAL EFFLUENT FLUID AND A PERITONEAL EFFLUENT FLUID CULTURE AND CELL COUNT WERE OBTAINED (WBC CELL COUNT = 2278 U/L, POLYMORPHS = 79%) AND THE PATIENT WAS DIAGNOSED WITH PERITONITIS. THE PATIENT WAS TREATED WITH INTRAPERITONEAL (IP) CEFEPI

  Patient problems: Abdominal Pain; Cramp(s) /Muscle Spasm(s); High Blood Pressure/ Hypertension; Peritonitis

  MAUDE report 19513610 ↗
• MalfunctionJun 7, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT DISCOVERED A FLUID LEAK BETWEEN THE EXTENSION SET AND CATHETER DURING THEIR PD TREATMENT. FLUID WAS NOTED TO BE SQUIRTING FROM THE CATHETER AREA. NO FLUID CAME IN CONTACT WITH THE CYCLER. THE PATIENT REPORTED RECEIVING AN AIR DETECTED IN CASSETTE ALARM DURING DRAIN 1 OF 3 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 ADVISED TO DISCONTINUE THE USE OF THEIR CYCLER AND FOLLOW UP WITH THEIR PERITONEAL DIALYSIS NURSE (PDRN). IT WAS REPORTED THAT AN ALTERNATE TREATMENT OPTION WAS AVAILABLE. UPON FOLLOW UP, IT WAS CONFIRMED THAT 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 PERITONEAL DIALYSIS THERAPY WITH NO FURTHER ISSUES. THE CYCLER SET AND EXTENSION SET USED BY THE PATIENT WERE DISCARDED AND IS NOT AVAILABLE FOR RETURN FOR PHYSICAL EVALUATION BY THE MANUFACTURER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19487100 ↗
• MalfunctionFeb 23, 2024Fluid/Blood Leak; Fluid/Blood Leak

  A PERITONEAL DIALYSIS (PD) PATIENT REPORTED THE PATIENT BECAME DISCONNECTED FROM THE PATIENT LINE DURING AN UNKNOWN PHASE AND CYCLE OF TREATMENT. THE PATIENT'S PD CATHETER WAS STILL INTACT AND THE PATIENT WAS NO LONGER CONNECTED AT THE TIME OF THE CALL. THE PATIENT KNEW HOW TO PERFORM CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD) THERAPY. THE PATIENT WAS ADVISED TO CLOSE ALL CLAMPS AND LET THE PERITONEAL DIALYSIS REGISTERED NURSE (PDRN) KNOW THE SITUATION. UPON FOLLOW-UP, THE PDRN CONFIRMED THE REPORTED EVENT. THE PDRN STATED THE PATIENT USED A 18-INCH STAY SAFE LUER LOCK CATHETER EXTENSION WHICH DISCONNECTED FROM THE PATIENT LINE OF THE CYCLER SET DURING AN UNKNOWN PHASE AND CYCLE OF TREATMENT AND CAUSED A FLUID LEAK TO OCCUR. IT IS UNKNOWN HOW THE DISCONNECTION OCCURRED, BUT THE PDRN SUSPECTED THE PATIENT MAY NOT HAVE PROPERLY TIGHTENED THE CONNECTION. THE PATIENT REVERTED TO MANUALS TO COMPLETE THEIR REMAINING TREATMENT. PER PDRN THE PATIENT WAS REQUESTED TO COME INTO THE CLINIC THE SAME MORNING AND WAS PRESCRIBED PROPHYLACTIC MEDICATION (VANCOMYCIN, 2G, INTRAPERITONEAL (IP) AS A PRECAUTION. PER PDRN THE PATIENT'S EXTENSION SET WAS ALSO REPLACED AS A PRE-CAUTION. THE PATIENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18773351 ↗
• MalfunctionFeb 16, 2024Fluid/Blood Leak; Fluid/Blood Leak

  A PERITONEAL DIALYSIS (PD) PATIENT¿S PD NURSE REPORTED THAT DURING PD TREATMENT THERE WAS A FLUID LEAK ENCOUNTERED. TREATMENT WAS STOPPED AND A HOLE WAS DISCOVERED UNDER THE WHITE CLAMP ON THE EXTENSION SET. THE PATIENT WAS PRESCRIBED PROPHYLACTIC ANTIBIOTICS. IN A FOLLOW UP, THE NURSE SAID THERE WERE NO SYMPTOMS, ADVERSE EVENTS, OR INJURIES REQUIRING MEDICAL INTERVENTION AS A RESULT OF THE REPORTED EVENT.THE NURSE DID VERIFY THAT THE PROPHYLACTIC TREATMENT WAS ADMINISTERED. THE CYCLER SET IS AVAILABLE TO RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18727207 ↗
• InjuryAug 14, 2023Break; Break

  A VOLUNTARY MEDWATCH MW5119435 WAS RECEIVED. THE REPORT STATED THAT THE CATHETER EXTENSION SET WITH LUER-LOCK TIP FELL OFF. THE PATIENT NOTICED A LEAK AND AS A RESULT WAS HOSPITALIZED. ADDITIONAL INFORMATION WAS PROVIDED BY FOLLOW-UP WITH THE PERITONEAL DIALYSIS REGISTERED NURSE (PDRN). THE PATIENT WAS SEEN IN THE PD CLINIC ON (B)(6) 2023 AFTER THE CAP ON THE LUER-LOCK END OF THE CATHETER EXTENSION SET FELL OFF. THE PATIENT NOTED A LEAK AFTER THE CAP FELL OFF. THE PATIENT WAS NOT IN ACTIVE TREATMENT AT THE TIME OF THE CAP FALLING OFF. WHILE AT THE CLINIC, THE PATIENT¿S EXTENSION SET WAS EXCHANGED FOR A NEW ONE. THE EXTENSION SET WAS DISCARDED. THE PATIENT WAS ADMINISTERED ANTIBIOTICS (DRUG, ROUTE, AND DOSE NOT PROVIDED). ON (B)(6) 2023 THE PATIENT PRESENTED TO THE HOSPITAL WITH COMPLAINTS OF ABDOMINAL PAIN. THE PATIENT WAS ADMITTED WITH A DIAGNOSIS OF PERITONITIS. A PD EFFLUENT CULTURE RESULTED POSITIVE FOR STAPHYLOCOCCUS AUREUS. THE PATIENT WAS PRESCRIBED ANTIBIOTIC THERAPY WITH VANCOMYCIN (ROUTE, DOSE, FREQUENCY, AND DURATION UNKNOWN). THE PATIENT WAS DISCHARGED ON (B)(6) 2023.

  Patient problems: Abdominal Pain; Peritonitis

  MAUDE report 17541919 ↗
• InjuryAug 14, 2023Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  A VOLUNTARY MEDWATCH MW5119435 WAS RECEIVED. THE REPORT STATED THAT THE CATHETER EXTENSION SET WITH LUER-LOCK TIP FELL OFF. THE PATIENT NOTICED A LEAK AND AS A RESULT WAS HOSPITALIZED. ADDITIONAL INFORMATION WAS PROVIDED BY FOLLOW-UP WITH THE PERITONEAL DIALYSIS REGISTERED NURSE (PDRN). THE PATIENT WAS SEEN IN THE PD CLINIC ON 05/JUL/2023 AFTER THE CAP ON THE LUER-LOCK END OF THE CATHETER EXTENSION SET FELL OFF. THE PATIENT NOTED A LEAK AFTER THE CAP FELL OFF. THE PATIENT WAS NOT IN ACTIVE TREATMENT AT THE TIME OF THE CAP FALLING OFF. WHILE AT THE CLINIC, THE PATIENT¿S EXTENSION SET WAS EXCHANGED FOR A NEW ONE. THE EXTENSION SET WAS DISCARDED. THE PATIENT WAS ADMINISTERED ANTIBIOTICS (DRUG, ROUTE, AND DOSE NOT PROVIDED). ON 07/JUL/2023 THE PATIENT PRESENTED TO THE HOSPITAL WITH COMPLAINTS OF ABDOMINAL PAIN. THE PATIENT WAS ADMITTED WITH A DIAGNOSIS OF PERITONITIS. A PD EFFLUENT CULTURE RESULTED POSITIVE FOR STAPHYLOCOCCUS AUREUS. THE PATIENT WAS PRESCRIBED ANTIBIOTIC THERAPY WITH VANCOMYCIN (ROUTE, DOSE, FREQUENCY, AND DURATION UNKNOWN). THE PATIENT WAS DISCHARGED ON 10/JUL/2023.

  Patient problems: Abdominal Pain; Peritonitis

  MAUDE report 17541916 ↗
• MalfunctionJun 2, 2023Fluid/Blood Leak; Fluid/Blood Leak

  A PERITONEAL DIALYSIS (PD) PATIENT'S CAREGIVER REPORTED THAT DURING FILL 1 OF PD TREATMENT THERE WAS A FLUID LEAK ENCOUNTERED. FLUID WAS LEAKING FROM THE PATIENT'S CATHETER EXTENSION LINE SET. IN A FOLLOW UP WITH THE PATIENT'S PD NURSE IT WAS VERIFIED THAT THE FLUID LEAK WAS DUE TO A TEAR IN THE TUBING OF THE EXTENSION SET. THERE WAS NO HARM, ADVERSE EVENT OR INTERVENTION DUE TO THE TEAR. THE NURSE WENT TO THE PATIENT'S HOME THAT EVENING OF THE EVENT AND CHANGED OUT THE EXTENSION SET FOR A NEW ONE. THERE IS NO EXTENSION SET AVAILABLE TO RETURN AS A SAMPLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17050818 ↗
• MalfunctionMar 27, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT DISCOVERED A FLUID LEAK FROM THEIR PATIENT LINE DURING THEIR PD TREATMENT. THE PATIENT REPORTED THAT THEY WOKE UP TO THE PATIENT LINE BEING DISCONNECTED FROM THEIR CATHETER AND NOTICED THEIR BED WAS SOAKED. THE PATIENT REPORTED RECEIVING AN AIR DETECTED IN CASSETTE ALARM DURING DRAIN 1 OF 4 OF TREATMENT AND THE TREATMENT WAS CANCELLED. FLUID WAS NOT DISCOVERED IN THE PUMP MODULE AREA. FLUID WAS NOT DISCOVERED ON THE EXTERNAL OF THE CASSETTE. IT IS UNKNOWN AT WHICH POINT IN THERAPY THE LEAK MAY HAVE BEGUN. THE CAUSE OF THE LEAK IS UNKNOWN. 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¿S EXTENSION SET WAS REPLACED IN THE CLINIC FOLLOWING THE INCIDENT. THE PATIENT DID NOT DEVELOP ANY SYMPTOMS, ADVERSE EVENTS, INJURIES, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THE REPORTED EVENT. THE EXTENSION SET WAS DISCARDED AND IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16620627 ↗
• MalfunctionMar 2, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT DISCOVERED FLUID LEAKING BETWEEN THE CATHETER AND TRANSFER SET. THE PATIENT REPORTED RECEIVING AN M31 AIR DETECTED IN CASSETTE ALARM DURING AN UNKNOWN FILL STAGE OF TREATMENT. THE CYCLER WAS REBOOTED AND PATIENT RECEIVED THE MWD WATCHDOG TIMER ERROR. IT IS UNKNOWN AT WHICH POINT IN THERAPY THE LEAK MAY HAVE BEGUN. UPON FOLLOW UP, THE PDRN REPORTED THE LEAK WAS DUE TO A LOOSE TRANSFER SET. THE PATIENT REPORTED THE LEAK WAS FROM THE CATHETER NOT THE CYCLER SET CASSETTE. IT WAS CONFIRMED THAT THE PATIENT WAS ABLE TO COMPLETE PERITONEAL DIALYSIS TREATMENT. THE PATIENT DID NOT DEVELOP ANY SYMPTOMS, ADVERSE EVENTS, INJURIES, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THE REPORTED EVENT. THE PATIENT WAS PRESCRIBED 1750 MG VANCOMYCIN AND 2000 MG CEFTAZIDIME ONE TIME ORDERS AS A PRECAUTION. THE PATIENT IS CONTINUING PERITONEAL DIALYSIS THERAPY WITH NO FURTHER ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13656258 ↗
• MalfunctionJan 6, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT DISCOVERED A FLUID LEAK FROM THE STAY SAFE PATIENT LINE CONNECTOR DURING FILL 1 OF THEIR PD TREATMENT. THE PATIENT CONTACT REPORTED RECEIVING A PATIENT LINE IS BLOCKED SOFT ALARM DURING FILL 1 OF 4 OF TREATMENT. IT IS UNKNOWN AT WHICH POINT IN THERAPY THE LEAK MAY HAVE BEGUN. THE PATIENT CONTACT REPORTED THAT THE FLUID LEAK WAS CAUSED BY A LOOSE CONNECTION. THE CATHETER IS NOT CONNECTING TIGHTLY TO THE PATIENT LINE CONNECTOR. THE PATIENT CONTACT ALSO REPORTED THAT THIS OCCURRED TWICE TONIGHT WITH TWO CASSETTES FROM THE SAME LOT NUMBER. FLUID DID NOT COME IN CONTACT WITH THE CYCLER. THE PATIENT CONTACT WAS ADVISED TO CANCEL THE PATIENT¿S TREATMENT AND FOLLOW UP WITH THEIR PERITONEAL DIALYSIS NURSE (PDRN). UPON FOLLOW UP, THE PDRN STATED THE PATIENT IS TRAINED ON PERFORMING STAT DRAINS, AS WELL AS MANUAL PERITONEAL DIALYSIS THERAPY IF NEEDED. THE PDRN STATED THAT THE PATIENT CANCELLED THEIR TREATMENT. THE PDRN STATED THAT THE FLUID LEAK OCCURRED FROM THE PATIENT LINE OF THE EXTENSION SET. THE PATIENT DID NOT DEVELOP ANY SYMPTOMS, ADVERSE EVENTS, INJURIES, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THE REPORTED EVENT. THE PAT

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11128790 ↗
• MalfunctionJan 6, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT DISCOVERED A FLUID LEAK FROM THE STAY SAFE PATIENT LINE CONNECTOR DURING FILL 1 OF THEIR PD TREATMENT. THE PATIENT CONTACT REPORTED RECEIVING A PATIENT LINE IS BLOCKED SOFT ALARM DURING FILL 1 OF 4 OF TREATMENT. IT IS UNKNOWN AT WHICH POINT IN THERAPY THE LEAK MAY HAVE BEGUN. THE PATIENT CONTACT REPORTED THAT THE FLUID LEAK WAS CAUSED BY A LOOSE CONNECTION. THE CATHETER IS NOT CONNECTING TIGHTLY TO THE PATIENT LINE CONNECTOR. THE PATIENT CONTACT ALSO REPORTED THAT THIS OCCURRED TWICE TONIGHT WITH TWO CASSETTES FROM THE SAME LOT NUMBER. FLUID DID NOT COME IN CONTACT WITH THE CYCLER. THE PATIENT CONTACT WAS ADVISED TO CANCEL THE PATIENT¿S TREATMENT AND FOLLOW UP WITH THEIR PERITONEAL DIALYSIS NURSE (PDRN). UPON FOLLOW UP, THE PDRN STATED THE PATIENT IS TRAINED ON PERFORMING STAT DRAINS, AS WELL AS MANUAL PERITONEAL DIALYSIS THERAPY IF NEEDED. THE PDRN STATED THAT THE PATIENT CANCELLED THEIR TREATMENT. THE PDRN STATED THAT THE FLUID LEAK OCCURRED FROM THE PATIENT LINE OF THE EXTENSION SET. THE PATIENT DID NOT DEVELOP ANY SYMPTOMS, ADVERSE EVENTS, INJURIES, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THE REPORTED EVENT. THE PAT

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11128755 ↗
• InjuryJan 30, 2020Adverse 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 INITIAL COMPLAINT DETAILS ALLEGED THAT THERE WAS AN UNSPECIFIED INFECTION. UPON FOLLOW UP ON (B)(6) 2020, THE INITIAL REPORTER, THE PATIENT¿S PD CLINIC¿S PROGRAM MANAGER (PM), REPORTED THAT THE PATIENT HAD PRESENTED TO THE LOCAL EMERGENCY ROOM ON (B)(6) 2019 FOR CLOUDY PD EFFLUENT AND ABDOMINAL PAIN. A PD EFFLUENT CULTURE WAS OBTAINED, AND THE PATIENT HAD A COMPUTED TOMOGRAPHY (CT) SCAN WITHOUT CONTRAST. NO MEDICATION WAS ADMINISTERED TO THE PATIENT AND THEY WERE DISCHARGED WITHIN 24 HOURS. ON (B)(6) 2019 THE PATIENT WAS SEEN AT THE PD CLINIC. THE PATIENT WAS ASYMPTOMATIC, AND IT WAS NOTED THAT THE PATIENT¿S PD EFFLUENT WAS SLIGHTLY CLOUDY. THE PATIENT WAS GIVEN ANTIBIOTICS VANCOMYCIN 1G AND GENTAMYCIN 100MG VIA INTRAPERITONEAL (IP) ADMINISTRATION AND INSTRUCTED TO SWELL FOR 6 HOURS. ON (B)(6) 2019 THERE WAS NO GROWTH AND NO ORGANISM SEEN ON THE CULTURE AFTER TWO DAYS. ON (B)(6) 2020 THE PATIENT WAS SEEN AT THE CLINIC FOR A FOLLOW-UP APPOINTMENT. PATIENT WAS ASYMPTOMATIC AND THEIR PD EFFLUENT WAS CLEAR. ANOTHER CULTURE WAS OBTAINED. THE PATIENT REPORTED THAT HIS PD CATHETER (COVIDIEN PRODUCT

  Patient problems: Abdominal Pain; Peritonitis

  MAUDE report 9646060 ↗