CombiSet Twister 03-2794-0Recalls & reported problems

Summary

The FDA's MAUDE database contains 91 adverse event reports that list this exact device (DI 00840861100316), received between May 25, 2017 and Jul 1, 2026 — classified as 1 death, 1 injury, 89 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (87 reports).

3 other recalls cover devices cleared under the same FDA submission (K022536); they may or may not involve this specific model.

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

Most reported problems

Recent adverse event reports

The 25 most recent of 91 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 1, 2026Fluid/Blood Leak

  A USER FACILITY REGISTERED NURSE (RN) REPORTED A HEMODIALYSIS (HD) PATIENT WAS DIALYZING AND FINISHING TREATMENT. WHILE RINSING BACK THE SALINE LINE DISCONNECTED FROM BLOOD TUBING, RESULTING IN BLOOD LEAK AND THE PATIENT WAS UNABLE TO BE RINSED BACK. THE ESTIMATED BLOOD LOSS (EBL) WAS UNKNOWN. THE SAMPLE WAS REPORTEDLY AVAILABLE TO BE RETURNED FOR EVALUATION. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT RECEIVED TO DATE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25684158 ↗
• MalfunctionMay 8, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THIS PATIENT ON HEMODIALYSIS EXPERIENCED BLOOD LOSS (A FULL HEMODIALYSIS CIRCUIT; APPROXIMATELY 300 ML) REQUIRING HEMOGLOBIN MONITORING. IT WAS REPORTED THAT THE TWISTER APPARATUS ON THE FRESENIUS ACCESS FLOW COMBISET BLOOD LINES DISSECTED UPON ROTATION OF THE DEVICE. IN ADDITIONAL FOLLOW-UP VIA EMAIL AND A CALL WITH A HEMODIALYSIS NURSE. IT WAS DISCOVERED THAT WITH IN ONE HOUR OF THE TREATMENT, THE PATIENT WAS HAVING AN ACCESS FLOW TEST PERFORMED AND WHEN THE TWISTER APPARATUS ON THE FRESENIUS COMBISET WAS ROTATED THE DEVICE CRACKED. IT WAS CONFIRMED THAT THERE WERE NO INTERNAL BLOOD LEAKS AND NO ALLEGATIONS AGAINST THE FRESENIUS HEMODIALYSIS MACHINE OR DIALYZER. IT WAS STATED A VISIBLE CRACK WAS OBSERVED WITH VISIBLE BLOOD LEAK ON THE FRESENIUS COMBISET. AS A RESULT, THE PATIENT¿S TREATMENT WAS ENDED. THE PATIENT WAS NOT RETURNED THEIR BLOOD IN THE HEMODIALYSIS CIRCUIT. THE HEMODIALYSIS NURSE REPORTED THAT THERE WAS NO CHANGE IN THE PATIENT¿S BLOOD PRESSURE. THE PATIENT WAS RESET UP WITH NEW SUPPLIES AND RECEIVED 250ML OF SALINE FROM THE NEWLY PRIMES DIALYSIS CIRCUIT (STANDARD OF CARE). THE NURSE CONFIRMED THAT THE PATIENT DID NOT REQUIRE ANY MEDICAL INTERVEN

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25129160 ↗
• MalfunctionMar 11, 2026Fluid/Blood Leak

  A USER FACILITY REGISTERED NURSE (RN) REPORTED THAT A COMBISET BLOOD LEAK OCCURRED DURING A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE RN NOTICED BLOOD LEAKING FROM THE HEPARIN LINE APPROXIMATELY FIFTEEN MINUTES INTO THE TREATMENT. THEY SUSPECTED THAT THE CAP ON THE END OF THE HEPARIN LINE WAS NOT SECURE BECAUSE IT POPPED OFF ONCE PRESSURE STARTED TO BUILD UP WITHIN THE CIRCUIT. THE HEPARIN LINE ALSO WAS NOT CLAMPED, AND AS A RESULT, BLOOD LEAKED OUT OF THE LINE WHEN THE CAP CAME OFF. THERE WERE NO ALARMS FROM THE MACHINE, A FRESENIUS 2008T. THE RN WAS ABLE TO STOP THE LEAK BY CLAMPING THE LINE, AND THE PATIENT¿S TREATMENT WAS CONTINUED USING THE SAME SUPPLIES. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS 100 ML. THE RN CONFIRMED THERE WAS NO PATIENT SERIOUS INJURY, NO ADVERSE EFFECTS WERE EXPERIENCED, AND NO MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THE REPORTED EVENT. THE PATIENT COMPLETED THEIR FULL TREATMENT ON THE MACHINE. THE SAMPLE WAS NOT AVAILABLE TO BE RETURNED FOR MANUFACTURER EVALUATION AS IT WAS REPORTEDLY DISCARDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24576443 ↗
• MalfunctionMar 3, 2026Fluid/Blood Leak

  A USER FACILITY FACILITY ADMINISTRATOR (FA) REPORTED ON (B)(6) 2026 A HEMODIALYSIS (HD) PATIENT WAS FORTY-FIVE MINUTES INTO DIALYSIS TREATMENT ON A FRESENIUS 2008T (S/N (B)(6)) MACHINE WHEN THE MACHINE PROMPTED WITH AN AIR LEAK DETECTED MESSAGE, AND STAFF NOTICED MICROBUBBLES IN THE BLOOD PUMP SECTION OF THE DIALYSIS TUBING LINE ON THE DIALYSIS MACHINE. TREATMENT WAS HALTED AND UPON REMOVAL OF THE TUBING, THE STAFF REPORTED BLOOD LEAK FROM A SMALL HOLE IN THE LINE OF THE TUBING. THE FA STATED THE MACHINE WAS NOT AFFECTED OR REMOVED FROM SERVICE AS THE LEAK WAS OBSERVED FROM THE TUBING LINE ITSELF. NO FURTHER DAMAGE AND/OR DEFECTS WERE NOTED. THE FA STATED THE BLOOD PUMP ROTOR WAS INSPECTED WITH NO NOTED ISSUES AND INDICATED THE MACHINE REMAINED IN SERVICE. A FRESENIUS 180NRE DIALYZER WAS USED FOR TREATMENT AND THE PATIENT'S BLOOD WAS PARTIALLY RETURNED FROM THE ARTERIAL SIDE OF THE SYSTEM. THE FA STATED THAT THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS BETWEEN 150-300 ML. THE FA STATED THERE WAS NO PATIENT INJURY, ADVERSE EVENTS, OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THE REPORTED EVENT. FOLLOWING THE EVENT, THE FA STATED THE PATIENT WAS RESTARTED ON THE SAME MACHINE AND T

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24503682 ↗
• MalfunctionFeb 13, 2026Fluid/Blood Leak

  A USER FACILITY¿S CLINIC MANAGER (CM) REPORTED THAT A FRESENIUS COMBISET BLOODLINE CAUSED A SALINE BAG TO BACKFILL WITH BLOOD THREE HOURS AND FORTY-FIVE MINUTES AFTER THE INITIATION OF A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. ALL OF THE CLAMPS ON THE SALINE BAG WERE CLAMPED AND BLOOD PULLED FROM THE BLOODLINES BACK INTO THE EMPTY SALINE BAG. THE BACKFILL WAS VISUALLY OBSERVED. THE MACHINE, A FRESENIUS 2008T MACHINE, ALARMED APPROPRIATELY WITH AN AIR DETECTOR ALARM. THERE WERE NO FILLING PROGRAMS ON THE MACHINE. THE CM REPORTED THAT THERE WERE NO QUICK DISCONNECTS ON THE DRAIN LINE AND THAT THE DRAIN LINE LENGTH AND HEIGHT WERE WITHIN SPECIFICATION. THE MACHINE WAS NOT REMOVED FROM SERVICE FOLLOWING THIS INCIDENT AND HAS NOT EXPERIENCED A RECURRENCE OF THE ISSUE. A FRESENIUS DIALYZER WAS ALSO IN USE. FOLLOWING THE INCIDENT, THE PATIENT¿S BLOOD WAS RETURNED; HOWEVER THE BLOOD THAT BACKED UP IN TO THE SALINE BAG COULD NOT BE RETURNED. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 50ML. THE PATIENT WAS RESTARTED ON THE SAME MACHINE AND TREATMENT COMPLETED SUCCESSFULLY WITH NEW SUPPLIES. THERE WAS NO PATIENT SERIOUS INJURY OR MEDICAL INTERVENTION REQUIRED DUE TO THIS EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24334144 ↗
• MalfunctionFeb 13, 2026Fluid/Blood Leak

  A USER FACILITY¿S CLINIC MANAGER (CM) REPORTED THAT ON (B)(6) 2026, A FRESENIUS COMBISET BLOODLINE CAUSED A SALINE BAG TO BACKFILL WITH BLOOD ONE HOUR AFTER THE INITIATION OF A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. ALL OF THE CLAMPS ON THE SALINE BAG WERE CLAMPED AND BLOOD PULLED FROM THE BLOODLINES BACK INTO THE EMPTY SALINE BAG. THE BACKFILL WAS VISUALLY OBSERVED. THE MACHINE, A FRESENIUS 2008T MACHINE, ALARMED APPROPRIATELY WITH AN AIR DETECTOR ALARM. THERE WERE NO FILLING PROGRAMS ON THE MACHINE. THE CM REPORTED THAT THERE WERE NO QUICK DISCONNECTS ON THE DRAIN LINE AND THAT THE DRAIN LINE LENGTH AND HEIGHT WERE WITHIN SPECIFICATION. THE MACHINE WAS NOT REMOVED FROM SERVICE FOLLOWING THIS INCIDENT AND HAS NOT EXPERIENCED A RECURRENCE OF THE ISSUE. A FRESENIUS DIALYZER WAS ALSO IN USE. FOLLOWING THE INCIDENT, THE PATIENT¿S BLOOD WAS RINSED BACK; HOWEVER, THE BLOOD THAT BACKED UP IN TO THE SALINE BAG COULD NOT BE RETURNED. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 50ML. THE PATIENT WAS RESTARTED ON THE SAME MACHINE AND TREATMENT COMPLETED SUCCESSFULLY WITH NEW SUPPLIES. THERE WAS NO PATIENT SERIOUS INJURY OR MEDICAL INTERVENTION REQUIRED DUE TO THIS EVENT. THE C

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24334135 ↗
• MalfunctionFeb 5, 2026Fluid/Blood Leak

  A REGISTERED NURSE (RN) /CLINICAL COORDINATOR (CC) FROM A USER FACILITY REPORTED THAT A COMBISET BLOOD LEAK OCCURRED DURING A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE CC SAID AN AIR DETECTOR MESSAGE WENT OFF ABOUT ONE AND A HALF HOURS INTO THE TREATMENT. THE TECHNICIAN OPERATING THE MACHINE COULD NOT CLEAR THE ALARM, SO THEY DECIDED TO RETURN THE PATIENT¿S BLOOD AND RE-STRING THE MACHINE. AS THE PATIENT¿S BLOOD WAS BEING REINFUSED, THE TECHNICIAN NOTICED BLOOD ON THE MACHINE AND SAW THAT IT WAS COMING FROM THE HEPARIN LINE T-CONNECTOR, JUST BELOW THE BLOOD PUMP ON THE ARTERIAL SIDE. THE BLOOD WAS LEAKING FROM THE CONNECTION POINT OF THE MAIN LINE TO THE T-CONNECTOR. AS THE SUPPLIES WERE BEING REMOVED, THE MAIN LINE COMPLETELY SEPARATED FROM THE CONNECTOR. THE CC SAID THE PATIENT¿S BLOOD HAD ALREADY BEEN RETURNED AND BLOOD LOSS FROM THE LEAK WAS MINIMAL. ESTIMATED BLOOD LOSS (EBL) FROM THE LEAK WAS LESS THAN 5 ML. PRIOR TO THE LEAK, THERE WERE NO KNOWN LOOSE CONNECTIONS ON THE COMBISET LINES. THE CC SAID THERE WERE NO LEAKS NOTICED DURING THE PRIMING PHASE. IN ADDITION, THERE WERE NO CHANGES OR DISRUPTIONS IN PRESSURE THAT COULD HAVE CONTRIBUTED TO THE FAILURE. THE CC CONFIRMED TH

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24274126 ↗
• MalfunctionDec 19, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED TO FRESENIUS THAT A BLOOD LEAK OCCURRED DURING THE PATIENT¿S HEMODIALYSIS (HD) TREATMENT WITH THE COMBISET BLOODLINES. A HOLE OCCURRED IN THE BLOOD PUMP TUBING SEGMENT THAT ALLOWED AIR TO ENTER THE CIRCUIT AND RESULTED IN A BLOOD LEAK. ADDITIONAL INFORMATION WAS OBTAINED DURING FOLLOW-UP. THE REPORTED ISSUE OCCURRED APPROXIMATELY TWO HOURS AFTER TREATMENT INITIATION. A PINHOLE WAS DETECTED IN THE BLOOD PUMP TUBING SEGMENT OF THE FRESENIUS BLOODLINES. AIR HAD FILLED THE SYSTEM. THE 2008T MACHINE ALARMED WITH AN AIR DETECTOR ALARM. THE VENOUS LINE COULD NOT BE RETURNED. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 200 ML. NO SERIOUS INJURY OR REQUIRED MEDICAL INTERVENTION RESULTED FROM THE REPORTED ISSUE. TREATMENT WAS RESETUP ON THE SAME MACHINE AND COMPLETED WITH NEW SUPPLIES. THE SAMPLE WAS DISCARDED AND IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. THE MACHINE WAS PULLED FROM SERVICE FOLLOWING TREATMENT. AN EVALUATION WAS PERFORMED AND NO ISSUES WERE IDENTIFIED. THE MACHINE WAS RETURNED TO SERVICE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23854416 ↗
• MalfunctionDec 19, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED TO FRESENIUS THAT A BLOOD LEAK OCCURRED DURING THE PATIENT¿S HEMODIALYSIS (HD) TREATMENT WITH THE COMBISET BLOODLINES. A HOLE OCCURRED IN THE BLOOD PUMP TUBING SEGMENT THAT ALLOWED AIR TO ENTER THE CIRCUIT AND RESULTED IN A BLOOD LEAK. ADDITIONAL INFORMATION WAS OBTAINED DURING FOLLOW-UP. THE REPORTED ISSUE OCCURRED APPROXIMATELY TWO HOURS AFTER TREATMENT INITIATION. A BLOOD LEAK WAS VISUALLY OBSERVED BY THE CLINIC STAFF. TREATMENT WAS PAUSED. THE PATIENT¿S BLOOD WAS RETURNED. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS NOT QUANTIFIED. NO SERIOUS INJURY OR REQUIRED MEDICAL INTERVENTION RESULTED FROM THE REPORTED ISSUE. TREATMENT WAS RESETUP ON THE SAME MACHINE AND COMPLETED WITH NEW SUPPLIES. THE SAMPLE WAS DISCARDED AND IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. THE MACHINE WAS PULLED FROM SERVICE FOLLOWING TREATMENT. AN EVALUATION WAS PERFORMED AND NO ISSUES WERE IDENTIFIED. THE MACHINE WAS RETURNED TO SERVICE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23854415 ↗
• MalfunctionNov 25, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE CLINIC MANAGER (CM) FOR A USER FACILITY REPORTED TO FRESENIUS THAT A BLOOD LEAK OCCURRED WITH THE COMBISET BLOODLINES DURING THE PATIENT'S HEMODIALYSIS (HD) TREATMENT. THE BIOMEDICAL TECHNICIAN (BIOMED) SETUP TREATMENT ON THE 2008T MACHINE AND COMPLETED ACCESS FLOW TESTING WITH USE OF THE BLOODLINES AS WELL AS TESTING AND RECIRCULATION ON THE 2008T MACHINE WITH NO EVIDENCE OF LEAKING. TREATMENT WAS INITIATED AND WITHIN 15 MINUTES THE BLOODLINES BEGAN LEAKING AT THE SWITCH. THE REGISTERED NURSE (RN) VISUALLY OBSERVED BLOOD "POURING." THE BLOOD PUMP WAS STOPPED. THE SWITCH WAS ABLE TO BE TURNED IN ORDER TO RETURN THE PATIENT'S BLOOD. THE PATIENT'S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 100 ML. NO SERIOUS INJURY OR REQUIRED MEDICAL INTERVENTION RESULTED FROM THE REPORTED ISSUE. TREATMENT WAS RESTARTED AND SUCCESSFULLY COMPLETED ON THE SAME MACHINE WITH NEW SUPPLIES. NO DAMAGE OR DEFECT WAS NOTED TO THE SAMPLE. THE SAMPLE WAS DISPOSED AND IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. IT WAS NOTED THAT OTHER BLOODLINE SETS FROM THE SAME BOX HAVE BEEN USED WITHOUT REOCCURRENCE OF THE REPORTED ISSUE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23646152 ↗
• MalfunctionNov 24, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY¿S REGISTERED NURSE (RN) REPORTED THAT A FRESENIUS COMBISET BLOODLINE LEAKED THIRTY MINUTES AFTER THE INITIATION OF A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE MACHINE, A FRESENIUS 2008T MACHINE, DID NOT ALARM, BUT WAS NOT EXPECTED TO. THE LEAK ORIGINATED FROM THE TWISTER CONNECTION. THERE WERE NO LOOSE CONNECTIONS OR ISSUES DURING PRIMING. THERE WERE NO CHANGES IN PRESSURE OR BLOOD FLOW RATE DURING TREATMENT. A FRESENIUS DIALYZER WAS ALSO IN USE. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 250ML. THERE WAS NO PATIENT SERIOUS INJURY OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THIS EVENT. THE PATIENT WAS RESTARTED ON THE SAME MACHINE AND TREATMENT COMPLETED SUCCESSFULLY WITH NEW SUPPLIES. THE COMPLAINT DEVICE WAS REPORTED TO BE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23638436 ↗
• MalfunctionNov 11, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY¿S REGISTERED NURSE (RN) REPORTED THAT A FRESENIUS COMBISET BLOODLINE DISCONNECTED AT THE TWISTER CONNECTOR ONE AND A HALF HOURS AFTER THE INITIATION OF A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE MACHINE, A FRESENIUS 2008T MACHINE, ALARMED APPROPRIATELY. FRESENIUS BLOODLINES WERE ALSO IN USE. THERE WERE NO ISSUES NOTED DURING PRIMING. THERE WERE NO CHANGES IN PRESSURE OF BLOOD FLOW RATE DURING THE TREATMENT. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 100ML. THERE WAS NO PATIENT SERIOUS INJURY OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THIS EVENT. THE PATIENT OPTED TO END TREATMENT TWO AND A HALF HOURS EARLY. THE PATIENT DID NOT HAVE ANY ISSUES AS A RESULT OF ENDING TREATMENT EARLY. THE COMPLAINT DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23525141 ↗
• MalfunctionOct 28, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY¿S REGISTERED NURSE (RN) REPORTED THAT A FRESENIUS COMBISET BLOODLINE'S TWISTER RACKED DURING A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) IS UNKNOWN. IT IS UNKNOWN IF THE COMPLAINT DEVICE IS AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. MULTIPLE ATTEMPTS HAVE BEEN MADE TO CONTACT THE CUSTOMER TO OBTAIN ADDITIONAL INFORMATION RELATED TO THE REPORTED EVENT. AT THIS TIME, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23404978 ↗
• MalfunctionOct 20, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY¿S REGISTERED NURSE (RN) REPORTED THAT A FRESENIUS COMBISET BLOODLINE LEAKED FORM THE TWISTER ONE HOUR AFTER THE INITIATION OF A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE MACHINE, A FRESENIUS 2008T MACHINE, DID NOT ALARM, BUT WAS NOT EXPECTED TO. A FRESENIUS DIALYZER WAS ALSO IN USE. THERE WERE NO ISSUES NOTED DURING PRIMING. THERE WAS NO DEFECT OR DAMAGE NOTED ON THE BLOODLINE. THERE WERE NO CHANGES IN PRESSURE OR BLOOD FLOW RATE DURING TREATMENT. THE PATIENT¿S BLOOD WAS RETURNED FOLLOWING THE REPORTED EVENT. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 20ML. THERE WAS NO PATIENT SERIOUS INJURY OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THIS EVENT. THE PATIENT WAS RESTARTED ON THE SAME MACHINE AND TREATMENT COMPLETED SUCCESSFULLY WITH NEW SUPPLIES. THE COMPLAINT DEVICE WAS REPORTED TO BE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23337339 ↗
• MalfunctionAug 19, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY¿S CLINIC MANAGER (CM) REPORTED THAT A FRESENIUS COMBISET BLOODLINE LEAKED FROM A SLIT IN THE BLOOD PUMP SEGMENT THREE HOURS AFTER THE INITIATION OF A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE MACHINE, A FRESENIUS 2008T MACHINE, ALARMED APPROPRIATELY WITH AN ¿AIR IN LINE¿ MESSAGE. A FRESENIUS DIALYZER WAS ALSO IN USE. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 300ML. THERE WAS NO PATIENT SERIOUS INJURY OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THIS EVENT. THE PATIENT WAS RESTARTED ON A NEW MACHINE AND TREATMENT COMPLETED SUCCESSFULLY WITH NEW SUPPLIES. FOLLOWING THE ISSUE, THE MACHINE WAS REMOVED FROM SERVICE. THE BIOMEDICAL TECHNICIAN (BMT) DID NOT FIND ANY ISSUES AND THE MACHINE WAS RETURNED TO SERVICE WITHOUT ANY REPAIRS OR ADJUSTMENTS. THE COMPLAINT DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22841181 ↗
• MalfunctionJul 30, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY¿S REGISTERED NURSE (RN) REPORTED THAT A FRESENIUS COMBISET BLOODLINE LEAKED FROM THE ACCESS DIAL IMMEDIATELY AFTER THE INITIATION OF THE PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE MACHINE, A FRESENIUS 2008T MACHINE, DID NOT ALARM, BUT WAS NOT EXPECTED TO. A FRESENIUS DIALYZER WAS ALSO IN USE. AFTER THE BLOODLINE WAS REMOVED IT WAS NOTED THAT THE ACCESS DIAL WOULD NOT TURN. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 300ML. THERE WAS NO PATIENT SERIOUS INJURY OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THIS EVENT. THE PATIENT WAS RESTARTED ON THE SAME MACHINE AND TREATMENT COMPLETED SUCCESSFULLY WITH NEW SUPPLIES. THE COMPLAINT DEVICE WAS REPORTED TO BE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. LOT NUMBER: NOT AVAILABLE. MULTIPLE ATTEMPTS HAVE BEEN MADE TO CONTACT THE CUSTOMER TO OBTAIN ADDITIONAL INFORMATION RELATED TO THE REPORTED EVENT. AT THIS TIME, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22667720 ↗
• InjuryJul 18, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE FACILITY ADMINISTRATOR (FA) REPORTED TO FRESENIUS THAT A BLOOD LEAK OCCURRED DURING THE PATIENT'S HEMODIALYSIS (HD) TREATMENT. THE VENOUS LINE BROKE OFF FROM THE TWIST DURING THE MIDDLE OF PATIENT TREATMENT. ADDITIONAL INFORMATION WAS RECEIVED DURING FOLLOW-UP. THE REPORTED ISSUE WAS DISCOVERED UPON COMPLETION OF THE PATIENT'S THREE-HOUR TREATMENT. THE BLOOD LEAK WAS VISUALLY OBSERVED. NO ALARMS WERE RECEIVED ON THE 2008T MACHINE. THERE WERE NO CHANGES OR DISRUPTIONS IN PRESSURE THAT COULD HAVE CAUSED THE ISSUE AND/OR MAY HAVE CAUSED THE MACHINE TO ALARM. NO LOOSE CONNECTION, DEFECT, OR DAMAGE WAS NOTED TO THE BLOODLINES PRIOR TO THE EVENT. ADDITIONALLY NO ISSUES WERE ENCOUNTERED WHILE PRIMING THE SETUP FOR THIS TREATMENT. THE PATIENT'S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 700 ML. THE PATIENT WAS SENT TO THE EMERGENCY DEPARTMENT AS A PRECAUTIONARY MEASURE. TESTING WAS CARRIED OUT UPON ADMISSION, PRESUMABLY TO ASCERTAIN ANY LEVEL OF ANEMIA OR ADVERSE EFFECTS ATTRIBUTED TO THE BLOOD LOSS. THE PATIENT WAS ADMITTED TO THE HOSPITAL ON THE SAME DAY AND PROVIDED A WHOLE BLOOD TRANSFUSION WHILE HOSPITALIZED. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2025. THERE WAS

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22545713 ↗
• MalfunctionJun 4, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY¿S CLINIC MANAGER (CM) REPORTED THAT A FRESENIUS BLOODLINE LEAKED FIFTEEN MINUTES INTO A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE LEAK WAS DUE TO FAULTY TWIST LINES THAT HAD NOT YET BEEN SWITCHED FOR ACCESS TESTING. THE MACHINE, A FRESENIUS 2008T MACHINE, DID NOT ALARM, BUT WAS NOT EXPECTED TO. A FRESENIUS DIALYZER WAS ALSO IN USE. THERE WERE NO LOOSE CONNECTIONS, CHANGES IN PRESSURE AND NO DAMAGE WAS SEEN ON THE BLOODLINE. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 50ML. THERE WAS NO PATIENT SERIOUS INJURY OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THIS EVENT. THE PATIENT WAS RESTARTED ON A NEW MACHINE AND TREATMENT COMPLETED SUCCESSFULLY WITH NEW SUPPLIES. THE COMPLAINT DEVICE WAS REPORTED TO BE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22141428 ↗
• MalfunctionApr 21, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY CLINICAL MANAGER (CM) REPORTED THAT A COMBISET BLOOD LEAK OCCURRED DURING A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. ADDITIONAL DETAILS WERE OBTAINED THROUGH FOLLOW-UP WITH THE FACILITY¿S CHARGE NURSE (CN). THE CN WAS UNSURE HOW LONG AFTER THE START OF TREATMENT THAT THE BLOOD LEAK WAS FIRST OBSERVED. THE LEAK WAS REPORTEDLY COMING FROM THE COMBISET TWISTER COMPONENT OF THE BLOODLINES. THE CN STATED THAT NO OBVIOUS DEFECT OR DAMAGE WAS NOTED AT THE LEAK LOCATION. THE CN SAID THE TWISTER COMPONENT HAD NOT YET BEEN ROTATED WHEN THE LEAKING WAS NOTICED. THERE WERE NO LOOSE CONNECTIONS NOTED. THE CN ALSO SAID THE MACHINE DID NOT ALARM. ONCE THE LEAK WAS NOTICED, THE PATIENT¿S BLOOD WAS NOT RETURNED. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS 300 ML. THE CN CONFIRMED THERE WAS NO PATIENT SERIOUS INJURY, NO ADVERSE EFFECTS WERE EXPERIENCED, AND NO MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THE REPORTED EVENT. THE PATIENT COMPLETED THEIR TREATMENT AFTER BEING RE-SETUP WITH NEW SUPPLIES ON THE SAME MACHINE. THE SAMPLE WAS NOT AVAILABLE TO BE SENT BACK FOR EVALUATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21877009 ↗
• MalfunctionMar 31, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY'S CLINIC MANAGER (CM) REPORTED THAT A FRESENIUS BLOODLINE HAD A CRACK IN IT DURING A PATIENT'S HEMODIALYSIS (HD) TREATMENT. THE MACHINE, A FRESENIUS 2008T MACHINE, ALARMED APPROPRIATELY WITH AN AIR DETECTOR ALARM. A FRESENIUS DIALYZER WAS ALSO IN USE. THE LEAK WAS NOTED TO ORIGINATE AT THE TWISTER LINE JUNCTION. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 300 ML. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THIS EVENT. THE PATIENT WAS RESTARTED ON THE SAME MACHINE AND TREATMENT COMPLETED SUCCESSFULLY WITH NEW SUPPLIES. NO ISSUES WERE NOTED DURING PRIMING. THE COMPLAINT DEVICE WAS REPORTED TO BE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21733354 ↗
• MalfunctionMar 17, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY¿S CLINIC MANAGER (CM) REPORTED THAT FRESENIUS BLOODLINE LEAKED DURING A PATIENT¿S HEMODIALYSIS (HD) TREATMENT DUE TO A PINHOLE IN THE VENOUS TRANSDUCER TUBING. THE MACHINE, A FRESENIUS 2008T MACHINE, ALARMED APPROPRIATELY WITH AN AIR DETECTOR ALARM. A FRESENIUS DIALYZER WAS ALSO IN USE. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 300ML. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THIS EVENT. THE PATIENT WAS RESTARTED ON A NEW MACHINE AND TREATMENT COMPLETED SUCCESSFULLY WITH NEW SUPPLIES. THE COMPLAINT DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21619573 ↗
• MalfunctionMar 4, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A PATIENT CARE TECHNICIAN (PCT) FROM A HEMODIALYSIS (HD) USER FACILITY REPORTED THAT A COMBI SET BLOOD LEAK OCCURRED DURING A PATIENT¿S HD TREATMENT. THE BLOOD LEAK OCCURRED WHEN THE FLOW LINE WAS REVERSED. IT WAS REPORTED THAT THE SAMPLE WAS NOT AVAILABLE TO BE RETURNED FOR EVALUATION. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION, AND THUS FAR NO FURTHER DETAILS HAVE BEEN PROVIDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21516833 ↗
• MalfunctionDec 24, 2024Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY CLINICAL MANAGER (CM) REPORTED THAT A COMBI SET BLOODLINE SEPARATED DURING A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE SEPARATION OCCURRED THREE HOURS INTO THE PATIENT¿S THREE-AND-A-HALF-HOUR TREATMENT. THE SALINE LINE REPORTEDLY ¿POPPED OFF¿ AT THE T-CONNECTION TO THE ARTERIAL BLOODLINE. THE CM STATED IT WAS ALMOST AS IF THE LINE WAS NOT PROPERLY ADHERED TO THE CONNECTOR. A STAFF MEMBER WAS AT THE MACHINE WHEN THIS OCCURRED, AND THEY WERE ABLE TO IMMEDIATELY CLAMP OFF THE LINES. THE PATIENT¿S TREATMENT WAS DISCONTINUED. THERE WERE NO MACHINE ALARMS THAT OCCURRED, AND THERE WERE NO OTHER KNOWN ISSUES LEADING UP TO THE EVENT. THE CM STATED THAT EVERYTHING ELSE SEEMED NORMAL. THE PATIENT¿S BLOOD WAS NOT RETURNED. BETWEEN BLOOD THAT LEAKED DUE TO THE SEPARATION AND BLOOD CONTAINED WITHIN THE CIRCUIT, THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS 325 ML. THE CM CONFIRMED THERE WAS NO PATIENT INJURY, NO ADVERSE EFFECTS WERE EXPERIENCED, AND NO MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THE REPORTED EVENT. IT WAS CONFIRMED THAT THE SAMPLE WAS AVAILABLE TO BE RETURNED FOR MANUFACTURER EVALUATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21013975 ↗
• MalfunctionNov 29, 2024Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY BIOMEDICAL TECHNICIAN REPORTED THAT THE ACCESS FLOW TWISTER ON A COMBI SET BLOODLINE SNAPPED WHILE IN USE RESULTING IN BLOOD LOSS. ADDITIONAL INFORMATION WAS PROVIDED UPON FOLLOW-UP WITH THE FACILITY ADMINISTRATOR (FA) FROM THE UNIT. THE FA REPORTED THAT ACCESS FLOW TESTING WAS BEING PERFORMED WHEN THE PRODUCT FAILURE OCCURRED. THE INCIDENT OCCURRED WITHIN THE FIRST THIRTY MINUTES OF HEMODIALYSIS (HD) TREATMENT. WHEN THE STAFF TWISTED THE TWISTER COMPONENT, IT SNAPPED AND BLOOD STARTED LEAKING OUT. THERE WERE NO MACHINE ALARMS. THERE WERE NO KNOWN CHANGES OR DISRUPTIONS IN PRESSURE THAT COULD HAVE CAUSED THE FAILURE. ONCE THE LEAK WAS IDENTIFIED, THE TREATMENT WAS IMMEDIATELY STOPPED, AND THE LINES WERE CLAMPED. THE PATIENT'S BLOOD WAS NOT RETURNED; ESTIMATED BLOOD LOSS (EBL) DUE TO THE EVENT WAS 250 ML. THE FA CONFIRMED THERE WAS NO PATIENT INJURY, NO ADVERSE EFFECTS WERE EXPERIENCED, AND NO MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THE REPORTED EVENT. THE PATIENT COMPLETED THEIR TREATMENT AFTER BEING RE-SETUP WITH NEW SUPPLIES ON THE SAME MACHINE. THE COMBI SET WAS NOT AVAILABLE TO BE RETURNED FOR EVALUATION AS IT WAS REPORTEDLY DISCARDED. PHOTOS OF THE DEF

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20811072 ↗
• MalfunctionAug 12, 2024Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY CLINIC MANAGER (CM) REPORTED A COMBISET BLOODLINE BROKE AT THE VENOUS LINE AT THE TOP OF TWIST PORT, CAUSING A BLOOD LEAK TO OCCUR. A PHOTO WAS PROVIDED FOR THE INVESTIGATION. UPON FOLLOW-UP, THE CM STATED STATED A BLOOD LEAK OCCURRED FROM A BREAKAGE IN THE WHITE TWIST PORT CONNECTED TO THE VENOUS LINE APPROXIMATELY TWENTY MINUTES AFTER INITIATION OF TREATMENT. THE MACHINE, A 2008T, ALARMED WITH AN AN ARTERIAL BLOOD LEAK ALERT. PER CM IT WAS UNKNOWN WHAT CAUSED THE PORT TO BREAK OFF. A FRESENIUS 2008T HEMODIALYSIS MACHINE AND FRESENIUS DIALYZER WERE BEING USED DURING THE INCIDENT. BLOOD TEST STRIPS WERE NOT REQUIRED OR USED. THE PATIENT'S BLOOD WAS RETURNED FROM THE ARTERIAL SIDE OF THE SET AND THE ESTIMATED BLOOD LOSS (EBL) WAS 300ML. IMMEDIATELY FOLLOWING THE EVENT, THE TREATMENT WAS HALTED AND THE PATIENT WAS RE-SETUP WITH A NEW DIALYZER AND BLOODLINES, AND COMPLETED THEIR TREATMENT ON THE SAME MACHINE. THE CM CONFIRMED THERE WAS NO PATIENT INJURY, NO ADVERSE EFFECTS WERE EXPERIENCED, AND NO MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THE REPORTED EVENT. THE COMBISET WAS DISCARDED AND WAS NO LONGER AVAILABLE TO BE RETURNED FOR EVALUATION. A PHOTO WAS PROVIDE

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19964234 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K022536. One submission often covers many models, so check the product and lot details in each record.

• Z-1047-2015 · Dec 19, 2014 · Terminated
  Fresenius Crit Line in a Clip (CLiC) with SW version 2.51 Model Number: CL10041001. A continuous real-time monitor for non-invasive hematocrit, oxygen saturation and percent chang
• Z-0860-2009 · Nov 25, 2008 · Terminated
  CombiSet True Flow Series, Hemodialysis Blood Tubing with Priming Set and Transducer Protectors, with Access Flow Reversing Connector (Twister) Product Code: 03-2794-0 Bonded Comb
• Z-0859-2009 · Nov 25, 2008 · Terminated
  CombiSet True Flow Series, Hemodialysis Blood Tubing with Priming Set and Transducer Protectors, with Access Flow Reversing Connector (Twister) Product Code: 03-2994-6 24 sets /