Safe-Lock® 050-95018Recalls & reported problems

Summary

The FDA's MAUDE database contains 509 adverse event reports that list this exact device (DI 00840861100811), received between Sep 8, 2017 and Aug 26, 2026 — classified as 21 injuries, 488 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (484 reports).

2 FDA recall records name this device's identifier.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Apr 28, 2021Terminated

   Exposed to freezing temperatures due to refrigerated truck malfunctions

   Z-2089-2021 · Root cause: Environmental control · FDA record ↗

2. Apr 28, 2021Terminated

   Exposed to freezing temperatures due to refrigerated truck malfunctions

   Z-2088-2021 · Root cause: Environmental control · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 509 reports, in the reporter's own words as published by the FDA.

• InjuryAug 26, 2026Fluid/Blood Leak

  A peritoneal dialysis (PD) patient contact reported to Fresenius Medical Care (FME) Technical Service (TS) on (b)(6) 2026 that the Liberty cycler alarmed with an M31 Air Detected in Cassette warning in Fill 5 of 5. The patient (PT) was connected during incident and fluid was seen. Upon follow-up conducted on (b)(6) 2026 the patient contact stated that on (b)(6) 2026 the patient¿s liberty cycler started to alarm with M31 Air Detected in Cassette warning in Fill 5 of 5. The patient contact stated that after disconnecting the patient from the cycler with the assistance of the Fresenius Technical support the patient noticed that there was some fluid on the floor. The contact confirmed that the patient uses and that they were using a 7.25% Baxter solution bag (lot unknown) for the last fill. The contact stated that the fluid leaked from the connection of the LUER LOCK CONNECTOR to the cassette. Per patient contact there were no external leaks from the Fresenius solution bag or any connections prior, during, or after the event. The patient contact also confirmed that there was no fluid intrusion inside the cycler as the result of the reported event. The contact stated that they did not k

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50458030 ↗
• MalfunctionMar 25, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT DISCOVERED A FLUID LEAK UNDERNEATH WHERE THE LAST BAG (LB) WAS HANGING DURING DWELL 3 OF 4 OF THEIR PD TREATMENT. THE PATIENT REPORTED RECEIVING AN AIR DETECTED IN CASSETTE ALARM DURING DWELL 3 OF 4 OF TREATMENT PRIOR TO THE LEAK AND THE TREATMENT WAS CANCELLED. THE PATIENT STATED HE HAD NOTICED "EXTRA CONDENSATION" THAN NORMAL, BUT HE DIDN'T THINK ANYTHING OF IT AT THE TIME OF SET UP. THE CAUSE OF THE LEAK IS UNKNOWN. TECHNICAL SUPPORT ASSISTED THE PATIENT WITH RE-SETUP OF THE CYCLER WITH NEW SUPPLIES AND STARTING TREATMENT FROM THE BEGINNING. THE PATIENT WAS ADVISED TO FOLLOW UP WITH THEIR PERITONEAL DIALYSIS NURSE (PDRN). UPON FOLLOW UP, THE PATIENT CONFIRMED THAT MOISTURE WAS FOUND ON THE BAXTER LB WHEN THE BAG WAS REMOVED FROM THE OUTER WRAP. THE PATIENT COULD NOT CONFIRM EXACTLY WHERE THE LEAK OCCURRED BUT FOUND A PUDDLE UNDERNEATH WHERE THE LB WAS HANGING. THE PATIENT DID NOT DEVELOP ANY SYMPTOMS, ADVERSE EVENTS, INJURIES, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THE REPORTED EVENT. THE PATIENT WAS ABLE TO COMPLETE PERITONEAL DIALYSIS TREATMENT USING NEW SUPPLIES AND THE CYCLER. THE PATIENT IS CONTINUING WITH PERI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21687275 ↗
• MalfunctionNov 27, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT CONTACT DISCOVERED A FLUID LEAK DURING AN UNKNOWN PHASE OF TREATMENT. THE PATIENT WAS CONNECTED DURING THE INCIDENT. FLUID WAS NOT DISCOVERED IN THE PUMP MODULE AREA OR ON THE EXTERNAL OF THE CASSETTE. FLUID LEAKED FROM AN UNKNOWN LOCATION, BUT PER THE PATIENT CONTACT, THE UNUSED LINES WERE UNCLAMPED. UPON FOLLOW UP, THE PATIENT CONTACT CONFIRMED THE REPORTED EVENT. THE PATIENT CONTACT STATED WAKING UP IN THE MIDDLE OF THE NIGHT TO FIND THE CYCLER CASSETTE DOOR BEING OPEN AND SOLUTION WAS ALL OVER THE CARPET. THERE WAS NO FLUID INSIDE THE CYCLER CASSETTE DOOR. THE PATIENT CONTACT THEN CHECKED THE EXTERNEAL BAXTER LAST BAG AND FOUND THAT 1/4 CUP OF FLUID HAD LEAKED FROM INNER BAG TO OUTER WRAP WITH ADDITIONAL FLUID LEAKING ONTO THE CARPET. THE PATIENT CONTACT COULD NOT CONFIRM IF THE LEAK WAS FROM THE BAG ITSELF OR THE ADAPTER CONNECTION. THE PATIENT CONTACT CONFIRMED THERE WAS NO LEAKING FROM THE FRESENIUS SOLUTION BAGS. THE PATIENT CONTACT STATED THAT THE PATIENT DID NOT DEVELOP ANY SYMPTOMS, ADVERSE EVENTS, INJURIES, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THE REPORTED EVENT. THE PATIENT CONTACT STATED THAT THE PATIEN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20796573 ↗
• MalfunctionJun 4, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT DISCOVERED A FLUID LEAK DURING PD TREATMENT. THE PATIENT REPORTED NOTICING FLUID DRIPPING AT THE ADAPTER SET CONNECTION DURING FILL FOUR OF TREATMENT. IT IS UNKNOWN AT WHICH POINT IN THERAPY THE LEAK MAY HAVE BEGUN. FLUID WAS NOT DISCOVERED ON THE CASSETTE INSIDE THE CASSETTE DOOR AND THERE WAS NO FLUID IN THE PUMP MODULE AREA OF THE CYCLER. UPON FOLLOW UP, THE PATIENT REPORTED THAT THERE WERE NOT ANY SYMPTOMS, ADVERSE EVENTS, INJURIES, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THE REPORTED EVENT. THE PATIENT WAS ABLE TO COMPLETE TREATMENT THAT NIGHT. THE ADAPTER IS NOT AVAILABLE FOR RETURN FOR PHYSICAL EVALUATION BY THE MANUFACTURER. THE PATIENT IS USING THE SAME CYCLER WITH NO FURTHER ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19462992 ↗
• MalfunctionMay 16, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT DISCOVERED A FLUID LEAK ON THE ADAPTER CONNECTION AFTER READJUSTING THE LAST BAG DURING THEIR PD TREATMENT. THE PATIENT REPORTED RECEIVING A SUPPLY BAG LINES ARE BLOCKED ALARM DURING DWELL 5 OF 5 OF TREATMENT. THERE WERE AIR BUBBLES IN THE SUPPLY BAG (SB) LINE. IT IS UNKNOWN AT WHICH POINT IN THERAPY THE LEAK MAY HAVE BEGUN. THE CAUSE OF THE LEAK WAS A CRACK ON THE ADAPTER. THE PATIENT CANCELLED TREATMENT. IT WAS REPORTED THAT AN ALTERNATE TREATMENT OPTION WAS NOT AVAILABLE. UPON FOLLOW UP, THE PD NURSE REPORTED IT IS UNKNOWN IF THERE WERE ANY LEAKS ON THE CYCLER SET OR CYCLER. THE PATIENT DOES USE BAXTER FOR THE LAST BAG OF TREATMENT. THERE HAVE BEEN NO FURTHER ISSUES WITH ANY FRESENIUS PRODUCTS REPORTED SINCE THE INCIDENT. THERE WAS NO CHANGE IN THE PATIENT'S STATUS. THE PATIENT COMPLETED TREATMENT ON THE DAY OF THE EVENT ON THE CYCLER WITHOUT THE LAST BAG OPTION. THE PATIENT HAS RECOVERED FROM THE INCIDENT. THE PATIENT DISCARDED THE SAFE LOCK ADAPTER AND IT IS NO LONGER AVAILABLE FOR PHYSICAL ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19332957 ↗
• MalfunctionMay 13, 2024Fluid/Blood Leak; Fluid/Blood Leak

  A PERITONEAL DIALYSIS (PD) PATIENT CONTACTED FRESENIUS TECHNICAL SUPPORT TO REPORT THE LIBERTY SELECT CYCLER WAS ALARMING WITH THE M31 AIR DETECTED IN CASSETTE WARNING DURING DWELL 4 OF 4 OF TREATMENT THE PATIENT WAS CONNECTED DURING INCIDENT. FLUID WAS SEEN ON THE FLOOR NEXT TO THE SUPPLY BAG. THE PATIENT BELIEVED FLUID WAS LEAKING FROM THE LAST BAG AT THE BAXTER ADAPTER CONNECTOR. THE LAST BAG WAS EMPTY AND THE SUPPLY BAG WAS HANGING. THE PATIENT LINE DID PRIME ALL THE WAY TO THE END AND THE UNUSED LINES WERE CLAMPED. THE PATIENT CANCELLED THE TREATMENT AND CONTINUED WITH CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD) THERAPY. UPON FOLLOW UP, IT WAS CONFIRMED THE PATIENT WAS ABLE TO COMPLETE TREATMENT ON THE REPORTED DAY. THE PATIENT STOPPED THE TREATMENT ON THE CYCLER AND WAS ABLE TO COMPLETE PERITONEAL DIALYSIS TREATMENT USING CAPD. NO PATIENT SERIOUS INJURIES WERE EXPERIENCED. PATIENT DID NOT SUFFER ANY ADVERSE EVENTS AND NO MEDICAL INTERVENTION WAS REQUIRED. THE PATIENT CONFIRMED FLUID WAS COMING FROM THE ADAPTER CONNECTOR. UPON FOLLOW-UP WITH THE PERITONEAL DIALYSIS REGISTERED NURSE (PDRN), THE PDRN CONFIRMED THE REPORTED EVENT AND STATED THE PATIENT CONTACTED THE ON-CALL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19299428 ↗
• MalfunctionApr 9, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT CONTACT DISCOVERED A FLUID LEAK NEAR THE LAST BAG DURING THEIR PD TREATMENT. THE PATIENT REPORTED RECEIVING AN AIR DETECTED IN CASSETTE ALARM DURING DWELL 4 OF 4 OF TREATMENT. FLUID LEAKED FROM SOMEWHERE ON THE ICODEXTRIN BAG OR THE LAST BAG LINE. THE CAUSE OF THE LEAK IS UNKNOWN. THE PATIENT WAS ADVISED TO FOLLOW UP WITH THEIR PERITONEAL DIALYSIS NURSE (PDRN). IT WAS REPORTED THAT AN ALTERNATE TREATMENT OPTION WAS AVAILABLE. UPON FOLLOW UP, THE PATIENT CONTACT CONFIRMED THE REPORTED FLUID LEAK EVENT OCCURRED WITH A BAXTER ICODEXTRIN LAST BAG. THE PATIENT ALSO USES A FRESENIUS SAFE LOCK ADAPTER TO CONNECT TO THE LAST BAG. THE PATIENT CONTACT HAD NOTICED FLUID ON THE FLOOR BUT COULD NOT CONFIRM IF THE FLUID CAME FROM THE BAG ITSELF, THE ADAPTER CONNECTION, OR THE LAST BAG LINE ON THE CYCLER SET. THE PATIENT CONTACT CONFIRMED THERE WAS NO FLUID IN OR AROUND THE CYCLER. THE PATIENT CONTACT STATED THAT THE PATIENT DID NOT DEVELOP ANY SYMPTOMS, ADVERSE EVENTS, INJURIES, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THE REPORTED EVENT. THE PATIENT CONTACT STATED THE PATIENT SKIPPED THE REMAINDER OF TREATMENT WITH THE LAST BAG IN TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19075931 ↗
• MalfunctionJan 18, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT DISCOVERED A FLUID LEAK ON THE CONNECTION TO THE LAST BAG DURING THEIR PD TREATMENT. THE PATIENT REPORTED RECEIVING AN AIR DETECTED IN CASSETTE ALARM DURING DWELL 4 OF 4 OF TREATMENT. THE PATIENT REPORTED THE LAST BAG CONNECTION WAS NOT TIGHT ENOUGH. FLUID WAS ALSO SEEN ON THE CART SHELF. FLUID WAS NOT DISCOVERED IN THE PUMP MODULE AREA OR ON THE EXTERNAL OF THE CASSETTE. THE PATIENT WAS ADVISED ON HOW 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, THE PATIENT CONFIRMED THE REPORTED FLUID LEAK EVENT OCCURRED AT THE CONNECTION BETWEEN THE SAFE LOCK ADAPTER AND BAXTER BAG DURING THE LAST FILL OF TREATMENT. THE PATIENT TIGHTENED THE CONNECTION AS MUCH AS POSSIBLE, BUT IT STILL FELT AS IF IT WAS NOT FULLY TIGHTENED. THE PATIENT DID NOT DEVELOP ANY SYMPTOMS, ADVERSE EVENTS, INJURIES, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THE REPORTED EVENT. THE PATIENT SKIPPED THE REMAINDER OF PERITONEAL DIALYSIS TREATMENT IN THE ABSENCE OF THE CYCLER. THE PATIENT IS CONTINUING WITH PERITONEAL DIALYSIS ON THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18539269 ↗
• MalfunctionNov 28, 2023Fluid/Blood Leak; Fluid/Blood Leak

  A PERITONEAL DIALYSIS (PD) PATIENT REPORTED TO FRESENIUS TECHNICAL SERVICE ON 11/22/2023 THAT A FLUID LEAK HAD OCCURRED DURING THEIR PD TREATMENT. THE PATIENT REPORTED THE CYCLER HAD AN AIR DETECTED IN CASSETTE MESSAGE DURING DWELL 4 OF 4 PRIOR TO THE FLUID LEAK. TWO SOLUTION BAGS WERE HANGING AND ONE LYING FLAT. PATIENT LINE, HEATER BAG, AND SOLUTION BAG WERE SECURELY CONNECTED. FLUID WAS NOT DISCOVERED IN THE PUMP MODULE AREA, HOWEVER FLUID WAS DISCOVERED ON THE EXTERNAL OF THE CASSETTE. FLUID LEAKED FROM BELOW THE CONNECTION OF THE LAST BAG. UPON FOLLOW UP, THE PERITONEAL DIALYSIS REGISTERED NURSE (PDRN) CONFIRMED THE REPORTED EVENT THROUGH TREATMENT DATA. THE PDRN STATED THAT THE PATIENT DID NOT DEVELOP ANY SYMPTOMS, ADVERSE EVENTS, INJURIES, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THE REPORTED EVENT PER THE TREATMENT DATA. THE PDRN STATED THAT THE PATIENT IS TRAINED ON PERFORMING STAT DRAINS, AS WELL AS MANUAL PERITONEAL DIALYSIS THERAPY IF NEEDED, HOWEVER COULD NOT CONFIRM IF THE PATIENT WAS ABLE TO COMPLETE PERITONEAL DIALYSIS TREATMENT USING CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD). THE PDRN CONFIRMED THAT THE PATIENT USES THE APD LUER LOCK ADAPTER WITH BAXTE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18222139 ↗
• MalfunctionNov 28, 2023Fluid/Blood Leak; Fluid/Blood Leak

  A PERITONEAL DIALYSIS (PD) PATIENT'S CAREGIVER REPORTED A FLUID LEAK DISCOVERED FROM A BAXTER BAG CONNECTION DURING DWELL 4 OF 4 OF TREATMENT. THE CONTACT REPORTED THE CYCLER PROMPTED WITH AN M31 AIR DETECTED IN CASSETTE WARNING MESSAGE DURING DWELL 4 OF 4 OF TREATMENT AND PRIOR TO THE OBSERVATION OF THE FLUID LEAK. THE PATIENT WAS CONNECTED DURING THE INCIDENT. FLUID WAS FLUID WAS NOT DISCOVERED IN THE PUMP MODULE AREA OR ON THE EXTERNAL OF THE CASSETTE. FLUID LEAKED FROM A BAXTER BAG CONNECTION. TREATMENT WAS CANCELLED AND THE PATIENT KNEW HOW TO PERFORM CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD) THERAPY. UPON FOLLOW-UP, THE CONTACT CONFIRMED THE REPORTED EVENT AND STATED THE PATIENT DID NOT DEVELOP ANY SYMPTOMS, ADVERSE EVENTS, INJURIES, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THE REPORTED EVENT. THE CONTACT STATED THE PATIENT IS TRAINED ON PERFORMING STAT DRAINS, AS WELL AS MANUAL PERITONEAL DIALYSIS THERAPY IF NEEDED AND COMPLETED PERITONEAL DIALYSIS TREATMENT USING CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD) THE FOLLOWING MORNING VIA TWO MANUAL EXCHANGES. THE CONTACT STATED THE PATIENT USED AN APD LUER LOCK ADAPTER WITH A BAXTER SOLUTION BAG AS THE LAST BAG

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18220644 ↗
• MalfunctionJul 21, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT DISCOVERED A FLUID LEAK DURING DWELL 4 OF THEIR PD TREATMENT. THE FLUID LEAKED FROM THE BAXTER ADAPTER CONNECTION. THERE WERE NO ALARMS PRIOR TO DISCOVERING THE LEAK. 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). ADDITIONAL INFORMATION WAS REQUESTED, HOWEVER TO DATE HAS NOT BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17371648 ↗
• MalfunctionAug 26, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT DISCOVERED THAT THE LAST BAG HAD DISCONNECTED FROM THE LAST BAG LINE DURING THEIR PD TREATMENT. IT WAS REPORTED THAT THE CONNECTION MAY HAVE BEEN SLIGHTLY LOOSE. THE PATIENT REPORTED RECEIVING AN AIR DETECTED IN CASSETTE WARNING DURING DWELL 4 OF 4 OF TREATMENT. THE PATIENT WAS ADVISED TO DISCONTINUE THE USE OF THEIR CYCLER AND FOLLOW UP WITH THEIR PERITONEAL DIALYSIS NURSE (PDRN). UPON FOLLOW UP, THE PATIENT STATED THAT THEY RECEIVED AN AIR DETECTED IN CASSETTE WARNING DURING DWELL 4 OF 4 AND UPON LOOKING AROUND TO SEE WHAT WAS CAUSING THE ALARM THE PATIENT NOTICED THAT THE BAXTER BAG WAS DISCONNECTED AND LEAKING. THE PATIENT STATED THAT THEY WERE NOT SURE WHY THE BAXTER BAG CAME DISCONNECTED. THE PATIENT STATED THAT NO FLUID GOT IN OR NEAR THE CYCLER. THE PATIENT STATED THAT THERE WAS NO ISSUE WITH THE LIBERTY CYCLER SET AND STATED THAT ONLY THE BAXTER BAG LINE HAD LEAKED. THE PATIENT IS TRAINED ON PERFORMING STAT DRAINS, AS WELL AS MANUAL PERITONEAL DIALYSIS THERAPY IF NEEDED. THE CYCLER HAS BEEN WORKING WELL AND THE PATIENT IS CONTINUING PERITONEAL DIALYSIS THERAPY WITH NO FURTHER ISSUES. THE PATIENT DID NOT DEVELOP ANY SY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15303233 ↗
• MalfunctionMay 9, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT DISCOVERED A FLUID LEAK FROM THE GREEN CLAMP LINE DURING THEIR PD TREATMENT. IT WAS REPORTED THAT THE CONNECTION MAY HAVE BEEN SLIGHTLY LOOSE. THE PATIENT REPORTED RECEIVING A SUPPLY BAG LINES ARE BLOCKED MESSAGE DURING DWELL 5 OF 5 OF TREATMENT. 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). UPON FOLLOW UP, THE PATIENT STATED THAT THEY RECEIVED AN AIR DETECTED IN CASSETTE MESSAGE AND SUPPLY BAG LINES ARE BLOCKED MESSAGE DURING DWELL 5 OF 5 AND UPON LOOKING AROUND TO SEE WHAT WAS CAUSING THE ALARM THE PATIENT NOTICED THAT THE BAXTER BAG WAS DISCONNECTED AND LEAKING. THE PATIENT STATED THAT THEY WERE NOT SURE WHY THE BAXTER BAG CAME DISCONNECTED. THE PATIENT STATED THAT NO FLUID GOT IN OR NEAR THE CYCLER. THE PATIENT IS TRAINED ON PERFORMING STAT DRAINS, AS WELL AS MANUAL PERITONEAL DIALYSIS THERAPY IF NEEDED, AND CONFIRMED THAT THEY WERE ABLE TO COMPLETE PERITONEAL DIALYSIS TREATMENT USING CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD) IN THE ABSENCE OF

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14340564 ↗
• MalfunctionApr 14, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT DISCOVERED FLUID LEAKING FROM THE CONNECTION OF THE PATIENT'S BAXTER SOLUTION BAG TO SAFE LOCK APD LUER LOCK CONNECTOR AFTER ENDING THEIR PD TREATMENT. THE PATIENT REPORTED RECEIVING AN AIR DETECTED IN CASSETTE ALARM DURING DWELL 4 OF 4 OF TREATMENT. IT IS UNKNOWN AT WHICH POINT IN THERAPY THE LEAK MAY HAVE BEGUN. THE CAUSE OF THE LEAK IS UNKNOWN. FLUID WAS NOT DISCOVERED WITHIN THE PUMP MODULE AREA OF THE CYCLER, AND NO FLUID WAS FOUND ON THE EXTERNAL OF THE CASSETTE. THE PATIENT WAS ADVISED TO DISCONTINUE THE USE OF THEIR CYCLER AND FOLLOW UP WITH THEIR PERITONEAL DIALYSIS NURSE (PDRN). A NEW CYCLER WAS ISSUED TO THE PATIENT. IT WAS REPORTED THAT AN ALTERNATE TREATMENT OPTION WAS AVAILABLE. UPON FOLLOW UP THE PDRN DECLINED TO PROVIDE ADDITIONAL INFORMATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT TO DATE HAS NOT BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14115351 ↗
• MalfunctionMar 30, 2022Fluid/Blood Leak; Fluid/Blood Leak

  THE PERITONEAL DIALYSIS (PD) PATIENT REPORTED TO FRESENIUS VIA A CUSTOMER SURVEY RESPONSE THAT THEIR BAXTER BAG COMES UNDONE VERY OFTEN AND LEAKS ONTO THEIR CARPET FLOOR. THE PATIENT¿S CAREGIVER ENSURES THE CONNECTION IS TIGHT, HOWEVER THE BAG STILL FALLS OFF AND LEAKS. THEY STATED THAT THEY HAVE TOLD FRESENIUS THAT THE BAXTER CONNECTION COMES UNDONE AND THEN THE REST OF THE CAPS WILL BE FINE FOR MONTHS AND THEN IT WILL LEAK BY FALLING OFF. ADDITIONAL INFORMATION WAS REQUESTED, HOWEVER A RESPONSE WAS NOT RECEIVED. IT WAS NOT REPORTED THAT THE PATIENT EXPERIENCED A SERIOUS INJURY, ADVERSE EVENT, OR REQUIRED MEDICAL INTERVENTION AS A RESULT OF THE REPORTED ISSUE. NO PARTS WERE RETURNED TO THE MANUFACTURER FOR A PHYSICAL EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13957375 ↗
• MalfunctionMar 30, 2022Fluid/Blood Leak; Fluid/Blood Leak

  THE PERITONEAL DIALYSIS (PD) PATIENT REPORTED TO FRESENIUS VIA A CUSTOMER SURVEY RESPONSE THAT THEIR BAXTER BAG COMES UNDONE VERY OFTEN AND LEAKS ONTO THEIR CARPET FLOOR. THE PATIENT¿S CAREGIVER ENSURES THE CONNECTION IS TIGHT, HOWEVER THE BAG STILL FALLS OFF AND LEAKS. THEY STATED THAT THEY HAVE TOLD FRESENIUS THAT THE BAXTER CONNECTION COMES UNDONE AND THEN THE REST OF THE CAPS WILL BE FINE FOR MONTHS AND THEN IT WILL LEAK BY FALLING OFF. ADDITIONAL INFORMATION WAS REQUESTED, HOWEVER A RESPONSE WAS NOT RECEIVED. IT WAS NOT REPORTED THAT THE PATIENT EXPERIENCED A SERIOUS INJURY, ADVERSE EVENT, OR REQUIRED MEDICAL INTERVENTION AS A RESULT OF THE REPORTED ISSUE. NO PARTS WERE RETURNED TO THE MANUFACTURER FOR A PHYSICAL EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13957327 ↗
• MalfunctionMar 11, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT DISCOVERED THAT THE BAXTER BAG WAS LEAKING FROM THE TUBING ADAPTER. THE PATIENT REPORTED RECEIVING AN AIR DETECTED IN CASSETTE ALARM DWELL 5 OF 6 OF TREATMENT. THE ALARM OCCURRED THREE TIMES AND HAD NOT OCCURRED PREVIOUSLY. THE CAUSE OF THE LEAK IS UNKNOWN. THE CYCLER WAS REBOOTED AND TREATMENT CANCELLED. THE PATIENT COMPLETED END OF TREATMENT STEPS AND FOUND NO MOISTURE ON THE CASSETTE. THE PATIENT WAS ADVISED TO FOLLOW UP WITH THEIR PERITONEAL DIALYSIS NURSE (PDRN). UPON FOLLOW UP, THE PATIENT IS TRAINED ON PERFORMING STAT DRAINS, AS WELL AS MANUAL PERITONEAL DIALYSIS THERAPY IF NEEDED. 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 CONNECTOR USED BY THE PATIENT WAS DISCARDED AND IS NOT AVAILABLE FOR RETURN FOR PHYSICAL EVALUATION BY THE MANUFACTURER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13739022 ↗
• MalfunctionFeb 28, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT DISCOVERED A FLUID LEAK COMING FROM THE SAFE LOCK CONNECTOR THAT WAS CONNECTED TO THE BAXTER BAG DURING THEIR PD TREATMENT. THE PATIENT REPORTED RECEIVING AN AIR DETECTED IN CASSETTE ALARM DURING DWELL 3 OF 4 OF TREATMENT AND THE TREATMENT WAS CANCELLED. THE CAUSE OF THE LEAK IS UNKNOWN. FLUID DID NOT COME IN CONTACT WITH THE CYCLER. IT WAS REPORTED THAT AN ALTERNATE TREATMENT OPTION WAS AVAILABLE. UPON FOLLOW UP, THE PATIENT CONFIRMED BEING TRAINED ON PERFORMING STAT DRAINS, AS WELL AS MANUAL PERITONEAL DIALYSIS THERAPY IF NEEDED. 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 ADAPTOR USED BY THE PATIENT WAS DISCARDED AND IS NOT AVAILABLE FOR RETURN FOR PHYSICAL EVALUATION BY THE MANUFACTURER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13619850 ↗
• MalfunctionFeb 23, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT DISCOVERED A FLUID LEAK FROM THE ADAPTER FOR THE BAXTER BAG DURING THEIR PD TREATMENT. THE PATIENT REPORTED RECEIVING AN AIR DETECTED IN CASSETTE ALARM DURING THEIR TREATMENT. 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 FOLLOW UP WITH THEIR PERITONEAL DIALYSIS NURSE (PDRN). A NEW CYCLER WAS ISSUED TO THE PATIENT. 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 DID NOT COMPLETE THEIR TREATMENT. THE PDRN STATED THAT THE FLUID LEAK OCCURRED FROM THE ADAPTER AND DID NOT COME IN CONTACT WITH THE CYCLER. 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 CONNECTOR USED BY THE PATIENT WAS DISCARDED AND IS NOT AVAILABLE FOR RETURN FOR PHYSICAL EVALUATION BY THE MANUFACTURER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13586673 ↗
• MalfunctionDec 28, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT DISCOVERED A FLUID DRIPPING FROM THE LAST BAG ONTO THEIR FLOOR DURING DWELL 5 OF 5 OF THEIR PD TREATMENT. THE PATIENT REPORTED RECEIVING AN AIR DETECTED IN CASSETTE ALARM PRIOR TO DISCOVERING THE LEAK. 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). A NEW CYCLER WAS ISSUED TO THE PATIENT. IT WAS REPORTED THAT AN ALTERNATE TREATMENT OPTION WAS AVAILABLE. UPON FOLLOW UP, THE PATIENT CONFIRMED THE REPORTED FLUID LEAK EVENT. THE PATIENT STATED THAT THE FLUID LEAK OCCURRED ON 12/23/2021. THERE WERE AIR DETECTED IN CASSETTE MESSAGES DURING DWELL 5 OF 5 OF TREATMENT AND UPON LOOKING AROUND, THE PATIENT NOTICED THAT THE LUER LOCK CONNECTOR WAS LEAKING ONTO THEIR FLOOR. THE PATIENT STATED THAT THE TUBING OF THE LUER LOCK CONNECTER WAS LEAKING AND CONFIRMED THAT NO FLUID GOT IN OR NEAR THE CYCLER AND HAD ONLY GOTTEN ONTO THEIR FLOOR. THE PATIENT STATED THAT THE BAXTER BAG WAS NOT LEAKING OR DAMAGED AND CONFIRMED THAT ONLY THE LUER LOCK CONNECTOR WAS LEAKING. THE PATIENT STATED THAT THE TUBING WAS LEAKING, BUT THEY COULD NOT FIND T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13097102 ↗
• InjuryDec 17, 2021Adverse 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 INITIALLY ADMITTED TO THE HOSPITAL WITH ABDOMINAL PAIN AND CLOUDY PD EFFLUENT. THE PATIENT WAS DIAGNOSED WITH PERITONITIS. THE PATIENT WAS DISCHARGED ON (B)(6) 2021. THE HOSPITAL COURSE IS UNKNOWN. ON (B)(6) 2021 THE PATIENT WAS SEEN AT THE PD CLINIC WITH SEVERE ABDOMINAL PAIN AND CLOUDY PD EFFLUENT. CULTURES WERE OBTAINED WHICH RESULTED POSITIVE FOR STENOTROPHOMONAS MALTOPHILIA. IT WAS DETERMINED THE PATIENT HAD NOT RECOVERED FROM THE INITIAL PERITONITIS HOSPITALIZATION AND WAS DIAGNOSED WITH PERITONITIS (RELAPSING). THE PATIENT¿S ANTIBIOTIC THERAPY IS UNKNOWN. ON (B)(6) 2021 THE PATIENT WAS HOSPITALIZED FOR THE REMOVAL OF THE PD CATHETER (NOT A FRESENIUS PRODUCT) AND IS CURRENTLY COMPLETING IN-CENTER HEMODIALYSIS (HD). IT WAS DETERMINED THE CAUSE OF THE PERITONITIS WAS THE PATIENT REUSING THE SAME FRESENIUS APD LUER-LOCK ADAPTER MULTIPLE TIMES. NO ADDITIONAL INFORMATION WAS OBTAINED.

  Patient problems: Abdominal Pain; Peritonitis

  MAUDE report 13026529 ↗
• MalfunctionNov 30, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT DISCOVERED A FLUID LEAK FROM THE APD LUER LOCK CONNECTION DURING DWELL 1 OF 4 OF THEIR PD TREATMENT. THERE WERE NO ALARMS ASSOCIATED WITH THE FLUID LEAK. 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 CANCEL TREATMENT AND RE-SETUP THE CYCLER WITH NEW SUPPLIES. UPON FOLLOW UP, THE PATIENT STATED THEY DID NOT COMPLETE TREATMENT ON THE NIGHT OF THE FLUID LEAK. THE PATIENT DID NOT DEVELOP ANY SYMPTOMS, ADVERSE EVENTS, INJURIES, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THE REPORTED EVENT. THE PATIENT CONFIRMED THEY ARE CONTINUING PERITONEAL DIALYSIS THERAPY WITH NO FURTHER ISSUES. THE LUER LOCK CONNECTOR USED BY THE PATIENT WAS DISCARDED AND IS NOT AVAILABLE FOR RETURN FOR PHYSICAL EVALUATION BY THE MANUFACTURER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12893966 ↗
• MalfunctionOct 22, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT¿S CONTACT DISCOVERED A FLUID LEAK FROM THE LUER LOCK APD ADAPTER DURING THEIR PD TREATMENT. THE PATIENT¿S CONTACT REPORTED THAT THE LUER LOCK APD ADAPTER WAS BENT AND LEAKING. THE PATIENT REPORTED RECEIVING AN AIR DETECTED IN CASSETTE ALARM DURING DWELL 5 OF 5 OF TREATMENT. 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). ADDITIONAL INFORMATION HAS BEEN REQUESTED, HOWEVER TO DATE HAS NOT BEEN RECEIVED. THERE WAS NO ADVERSE EVENT, SERIOUS INJURY, NOR MEDICAL INTERVENTION ATTRIBUTED TO THE REPORTED EVENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12681232 ↗
• MalfunctionSep 21, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT DISCOVERED A FLUID LEAK THE SAFE LOCK APD LUER LOCK CONNECTOR DURING THEIR PD TREATMENT. THE PATIENT REPORTED RECEIVING A SUPPLY BAG LINES ARE BLOCKED MESSAGE DURING DWELL 6 OF 6 OF TREATMENT. 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, THE PATIENT STATED THAT THE FLUID LEAK OCCURRED ON (B)(6)2021. THERE WERE SUPPLY BAG LINES ARE BLOCKED MESSAGES DURING DWELL 6 OF 6 OF TREATMENT AND UPON LOOKING AROUND, THE PATIENT NOTICED THAT THE LUER LOCK CONNECTOR WAS LEAKING. THE PATIENT STATED THAT THE TUBING OF THE LUER LOCK CONNECTER WAS LEAKING AND CONFIRMED THAT NO FLUID GOT IN OR NEAR THE CYCLER AND HAD ONLY GOTTEN ONTO THEIR FLOOR. THE PATIENT STATED THAT THE BAXTER BAG WAS NOT LEAKING OR DAMAGED AND CONFIRMED THAT ONLY THE LUER LOCK CONNECTOR WAS LEAKING. THE PATIENT STATED THAT THE TUBING WAS LEAKING, BUT THEY COULD NOT FIND THE HOLE IT WAS LEAKING FROM. THE CAUSE OF THE LEAK

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12506973 ↗
• InjuryJun 10, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THIS PATIENT ON PERITONEAL DIALYSIS (PD) WAS HOSPITALIZED WITH PERITONITIS. DURING ADDITIONAL FOLLOW-UP, THE PATIENT¿S PD NURSE STATED THAT ON (B)(6) 2021 THE PATIENT WAS HOSPITALIZED WITH SYMPTOMS OF ABDOMINAL PAIN. IT WAS REPORTED THE PATIENT WAS ADMITTED WITH PERITONITIS AS THE PATIENT¿S PD CULTURE (DATE UNKNOWN) WHICH YIELDED GROWTH OF THE ORGANISM KLEBSIELLA. DURING HOSPITALIZATION, THE PATIENT WAS TREATED WITH THE ANTIBIOTIC ROCEPHIN INTRA-PERITONEAL (IP). ADDITIONALLY, IT WAS REPORTED THE PATIENT INITIALLY CONTINUED PD IN THE HOSPITAL. HOWEVER, THE PATIENT WAS NOT ABLE TO CONTINUE PD HERSELF DUE TO OVERALL MALAISE FROM THE PERITONITIS INFECTION AND AS A RESULT THE PATIENT WAS SUBSEQUENTLY TRANSITIONED TO HEMODIALYSIS. ON (B)(6) 2021, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL TO A REHABILITATION FACILITY. THE PATIENT REMAINS ON HEMODIALYSIS CURRENTLY AND IS RECOVERING FROM THE PERITONITIS INFECTION, PER THE NURSE. THE NURSE REPORTED THAT ON AN UNKNOWN DATE (PRIOR TO HOSPITALIZATION) THE CONNECTION BETWEEN THE FRESENIUS APD ADAPTOR AND THE BAXTER ICODEXTRAN PD SOLUTION (NOT A FRESENIUS PRODUCT BECAME LOOSE AND CAUSED A FLUID LEAK. IT WAS ALSO REPORTED T

  Patient problems: Abdominal Pain; Peritonitis

  MAUDE report 11974804 ↗