CombiSet 03-2522-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 214 adverse event reports that list this exact device (DI 00840861102402), received between Nov 27, 2023 and Sep 23, 2026 — classified as 6 injuries, 208 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (177 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Jul 29, 2026Open, Classified

   Communication to recommend reviewing the IFU and ensuring that all treatment preparation and handling steps are performed as instructed.

   Z-3225-2026 · Root cause: Use error · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 214 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Incomplete or Inadequate Connection

  A user facility¿s registered nurse (RN) reported that a FME Combiset bloodline experienced transducer issues from the venous line during a patient¿s hemodialysis (HD) treatment. The machine, a FME 2008T machine, alarmed appropriately with trans-membrane pressure (TMP and venous pressure alarms. There were no loose connections or issues noted during priming. There were no changes in pressure or blood flow rate (BFR) during treatment. The patient completed treatment on the same machine after they replaced the transducer protector. There was no patient injury or medical intervention required due to the reported event. The complaint device is not available to be returned to the manufacturer for evaluation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50870270 ↗
• MalfunctionSep 23, 2026Incomplete or Inadequate Connection

  A user facility¿s registered nurse (RN) reported that a FME Combiset bloodline experienced transducer issues from the venous line during a patient¿s hemodialysis (HD) treatment. The machine, a FME 2008T machine, alarmed appropriately with trans-membrane pressure (TMP and venous pressure alarms. There were no loose connections or issues noted during priming. There were no changes in pressure or blood flow rate (BFR) during treatment. The patient completed treatment on the same machine after they replaced the transducer protector. There was no patient injury or medical intervention required due to the reported event. The complaint device is not available to be returned to the manufacturer for evaluation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50870268 ↗
• MalfunctionSep 15, 2026Fluid/Blood Leak

  A user facility Registered Nurse (RN) reported a blood leak from the venous line. Upon follow-up, the RN stated a blood leak occurred from a small hole on the venous line tubing thirty minutes after initiation of hemodialysis (HD) treatment. The machine, a 2008T, did not alarm as the blood leak was visually detected and treatment was immediately halted. A Fresenius FX CorAL 60 dialyzer was being used during the incident. Blood test strips were not required or used. The patient's blood was not returned and the estimated blood loss (EBL) was 300 mL. The RN confirmed there was no patient injury, no adverse effects were experienced, and no medical intervention was required as a result of the reported event. Following the event, the patient was re-setup with new supplies on a different machine and completed treatment without further issue. The Combi Set was discarded and was no longer available to be returned for evaluation.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50768019 ↗
• MalfunctionAug 5, 2026Incomplete or Inadequate Connection

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50143611 ↗
• MalfunctionAug 4, 2026Incomplete or Inadequate Connection

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50136109 ↗
• MalfunctionJul 6, 2026Fluid/Blood Leak; Incomplete or Inadequate Connection

  A USER FACILITY FACILITY ADMINISTRATOR REPORTED THEY HAD BEEN NOTICING THAT THE BLOODLINES HAD SMALLER TRANSDUCERS AND WERE THINKING ARE THE REASON THEY HAVE BEEN CLOTTING A LOT OF MACHINES VENOUS CHAMBERS. THERE WAS NO REPORTED BLOOD LOSS NOTED AT INTAKE. THE SAMPLE WAS REPORTED TO BE AVAILABLE TO BE RETURNED FOR EVALUATION. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT RECEIVED TO DATE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 25718990 ↗
• MalfunctionJul 6, 2026Incomplete or Inadequate Connection

  A USER FACILITY'S CLINIC MANAGER (CM) REPORTED THAT A FRESENIUS COMBISET BLOODLINE CAUSED AIR TO ENTER THE BLOODLINE FROM THE ARTERIAL CHAMBER DURING A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THERE WAS NO PATIENT SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED. THE COMPLAINT DEVICE IS NOT 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25717781 ↗
• MalfunctionJul 6, 2026Incomplete or Inadequate Connection

  A USER FACILITY'S CLINIC MANAGER (CM) REPORTED THAT A FRESENIUS COMBISET BLOODLINE CAUSED AIR TO ENTER THE BLOODLINE FROM THE ARTERIAL CHAMBER DURING A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THERE WAS NO PATIENT SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED. THE COMPLAINT DEVICE IS NOT 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25717780 ↗
• MalfunctionJul 6, 2026Incomplete or Inadequate Connection

  A USER FACILITY'S CLINIC MANAGER (CM) REPORTED THAT A FRESENIUS COMBISET BLOODLINE CAUSED AIR TO ENTER THE BLOODLINE FROM THE ARTERIAL CHAMBER DURING A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THERE WAS NO PATIENT SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED. THE COMPLAINT DEVICE IS NOT 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25717778 ↗
• MalfunctionJul 6, 2026Incomplete or Inadequate Connection

  A USER FACILITY'S CLINIC MANAGER (CM) REPORTED THAT A FRESENIUS COMBISET BLOODLINE CAUSED AIR TO ENTER THE BLOODLINE FROM THE ARTERIAL CHAMBER DURING A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THERE WAS NO PATIENT SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED. THE COMPLAINT DEVICE IS NOT 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25717653 ↗
• MalfunctionJun 26, 2026Incomplete or Inadequate Connection

  A FACILITY ADMINISTRATOR REPORTED A TRANSDUCER WAS PULLING AIR INTO THE SYSTEM.THE TRANSDUCER POPPED OFF WHILE STARTING PATIENT. IN A FOLLOW UP, THE REPORTER SAID TREATMENT WAS COMPLETED. THERE WAS NO HARM TO THE PATIENT. THERE WAS NO BLOOD LOSS FOR THE PATIENT. THE BLOOD PUMP WAS STOPPED AND NEW TRANSDUCER WAS ADDED TO THE LINES. THERE IS NO SAMPLE/COMPANION AVAILABLE TO SEND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25640983 ↗
• MalfunctionJun 22, 2026Incomplete or Inadequate Connection

  A CHARGE NURSE REPORTED THAT TRANSDUCERS INCLUDED WITH THE COMBISET ARE INTERFERING WITH TREATMENTS. THERE ARE REOCCURRING TRANSMEMBRANE PRESSURE (TMP) ALARMS AND INCREASED PRESSURES IN VENOUS CHAMBER MAKING BLOOD BACKFLOW INTO LINES. 9 TIMES OUT OF 10, TRANSDUCERS WITH THE COMBISET ARE CHANGE OUT WITH THE SPARE TRANSDUCER SUPPLIES. THE NEW STYLE CAP ON THE END OF HEPARIN LINES DOES NOT THREAD AND SECURE EFFICIENTLY. WHEN PRESSURES BUILD UP, THE CAP HAS BLOOD OFF THE END, POTENTIALLY HAVING BLOOD LOSS. THE COMBISET FROM ABOUT A YEAR AGO WAS PROBABLY THE MOST EFFICIENT PRODUCT. UPON FOLLOW UP, THE NURSE REPORTED THAT THE 2008T WITH BIBAG MACHINES PRODUCE TMP ALARMS RIGHT BEFORE THE INCREASED PRESSURE IN THE VENOUS CHAMBER CAUSES BLOOD BACKFLOWS THROUGH THE LINES AND INTO THE SALINE. APPROXIMATELY 10-100ML OF BLOOD ENTERED THE SALINE AND THE BLOOD WAS NOT RETURNED. THE NURSE VERIFIED THAT THERE WERE NO EXTERNAL LEAKS. THE NURSE STATED THE FACILITY RECEIVES BOTH OLD AND NEW TYPES OF TRANSDUCERS BUT ONLY NOTICED ISSUES WITH THE REPORTED LOT NUMBER 26BR01045 SINCE 5/25/2026. THE NURSE STATED THAT THE NEW TRANSDUCER CAPS FOR THE HEPARIN LINE DON'T TIGHTEN ENOUGH AND FEEL LIKE THERE'S STR

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25585440 ↗
• MalfunctionJun 22, 2026Incomplete or Inadequate Connection

  A HEMODIALYSIS (HD) PATIENT WAS CONNECTED TO A NEW MACHINE WITH NEW SUPPLIES. THE NURSE EXAMINED THE LINES WITH THE TRANSDUCER ON THE NEW 03-2522-1 COMBISET BLOODLINE, AND EVERYTHING APPEARED TO BE TIGHT. THEY BEGAN TO PRIME THE LINES, AND THE NURSE IMMEDIATELY SAW THE SALINE WENT INTO THE TRANSDUCERS. THE LINES WERE CHANGED AGAIN, AND THEY CHANGED THE TRANSDUCERS TO THE LARGER ONES, NOT THE ONES THAT COME ON THE 03-2522-1 COMBISET BLOODLINE. THERE WAS NO ISSUE WITH THE PRIMING OF THE LINES. THE PATIENT PROCEEDED TO UNDERGO TREATMENT AND COMPLETED THE FULL TREATMENT WITHOUT ANY FURTHER ISSUES. THE NURSE STATED THAT WHEN EXAMINING THE LINES, THE AIR WAS IN THE HEAD OF THE DIALYZER. THERE WAS NOTHING IN THE LINE FROM THE PATIENT TO THE MACHINE. THE AIR WAS FROM THE TRANSDUCER TO THE DIALYZER ONLY. THERE WAS NO REPORTED PATIENT HARM ASSOCIATED WITH THIS EVENT. THERE IS NO SAMPLE ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25579719 ↗
• InjuryJun 22, 2026Incomplete or Inadequate Connection

  A NURSE REPORTED THAT DURING A HEMODIALYSIS (HD) TREATMENT A PATIENT DEVELOPED CHEST PAIN DURING TREATMENT DUE TO AIR IN THE LINE. 911 WAS CALLED DUE TO AIR IN THE LINES AND THE VENOUS CHAMBER CLOTTING WHICH RESULTED IN NOT BEING ABLE TO RETURN BLOOD TO THE PATIENT. THE PATIENT DEVELOPED SIGNS AND SYMPTOMS OF AIR EMBOLISM. ADDITIONAL INFORMATION WAS OBTAINED THROUGH FOLLOW-UP WITH THE CLINICAL NURSE. THIS PATIENT WAS A FEW MINUTES INTO THE HEMODIALYSIS (HD) TREATMENT ON (B)(6) 2026 UTILIZING THE 03-2522-1 COMBISET BLOODLINE WHEN THE AIR DETECTORS ALARMED. THE PATIENT THEN TOLD THE PCT THAT THE PATIENT WAS NOT FEELING WELL. THE PCT TRIED TO RETURN THE PATIENT¿S BLOOD, BUT THE CHAMBER HAD ALREADY CLOTTED ON ONE SIDE. APPROXIMATELY 150ML OF BLOOD COULD NOT BE RETURNED. THE PATIENT THEN WENT UNCONSCIOUS. THE PATIENT HAD NO BLOOD PRESSURE (BP) READING AT THIS TIME. 911 WAS CALLED. THE CLINICAL NURSE CAME TO THE FLOOR. IT WAS THEN THAT SHE NOTED THE LINES AND CHAMBER WERE CLOTTED. AT THE SAME TIME, THE PATIENT WAS PLACED INTO TRENDELENBURG POSITION ON HIS LEFT SIDE FOR SUSPICION OF AIR EMBOLISM. THE NURSE STARTED A NEW INTRAVENOUS (IV) LINE TO ADMINISTER SALINE. 600ML OF NORMAL SALINE (N

  Patient problems: Chest Pain; Hemorrhage/Blood Loss/Bleeding; Loss of consciousness; Malaise

  MAUDE report 25579689 ↗
• MalfunctionJun 22, 2026Incomplete or Inadequate Connection

  A USER FACILITY'S CHARGE NURSE (CN) REPORTED THAT A FRESENIUS COMBISET TRANSDUCER WAS TOO SMALL ALLOWING AIR INTO THE SYSTEM DURING A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE MACHINE, A FRESENIUS 2008T MACHINE, ALARMED APPROPRIATELY WITH A TRANS-MEMBRANE PRESSURE (TMP) ALARM. A FRESENIUS BLOODLINE WAS ALSO IN USE. THERE WERE NO LOOSE CONNECTIONS OR ISSUES DURING PRIMING. THERE WAS NO DAMAGE NOTED ON THE BLOODLINE. NO BLOOD WAS LOST. THE VENOUS TRANSDUCER WAS REPLACED AND TREATMENT CONTINUED ON THE SAME MACHINE AND COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT SERIOUS INJURY OR MEDICAL INTERVENTION REQUIRED DUE TO THIS EVENT. THE COMPLAINT DEVICE WAS REPORTED TO BE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. SIX PHOTOS HAVE BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25576832 ↗
• MalfunctionJun 15, 2026Incomplete or Inadequate Connection

  A USER FACILITY¿S CLINIC MANAGER (CM) REPORTED THAT A FRESENIUS COMBISET BLOODLINE SEPARATED FROM THE SYSTEM PRIOR TO INITIATION OF TREATMENT. THERE WAS NO PATIENT INVOLVEMENT, HARM, OR ADVERSE EVENTS ASSOCIATED WITH THE REPORTED ISSUE. THEY USED THE PREVIOUS VERSION OF THE TRANSDUCER PROTECTOR TO COMPLETE THE SETUP WITHOUT ANY FURTHER ISSUES. NO PICTURES WERE PROVIDED. THE COMPLAINT DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25505341 ↗
• MalfunctionMay 26, 2026Fluid/Blood Leak

  A USER FACILITY REGISTERED NURSE (RN) REPORTED MULTIPLE ISSUES WITH AIR DETECTOR ALARMS, VENOUS PRESSURES AND CLOTTED LINES WITH BLOOD UNABLE TO BE RETURNED. THERE WERE NO PROBLEM WITH ACCESS OR LINES PREVIOUSLY. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT RECEIVED TO DATE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25285618 ↗
• MalfunctionMay 26, 2026Fluid/Blood Leak

  A USER FACILITY REGISTERED NURSE (RN) REPORTED MULTIPLE ISSUES WITH AIR DETECTOR ALARMS, VENOUS PRESSURES AND CLOTTED LINES WITH BLOOD UNABLE TO BE RETURNED. THERE WERE NO PROBLEM WITH ACCESS OR LINES PREVIOUSLY. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT RECEIVED TO DATE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25284392 ↗
• MalfunctionMay 26, 2026Fluid/Blood Leak

  A USER FACILITY REGISTERED NURSE (RN) REPORTED MULTIPLE ISSUES WITH AIR DETECTOR ALARMS, VENOUS PRESSURES AND CLOTTED LINES WITH BLOOD UNABLE TO BE RETURNED. THERE WERE NO PROBLEM WITH ACCESS OR LINES PREVIOUSLY. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT RECEIVED TO DATE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25284380 ↗
• MalfunctionMay 26, 2026Fluid/Blood Leak

  A USER FACILITY REGISTERED NURSE (RN) REPORTED MULTIPLE ISSUES WITH AIR DETECTOR ALARMS, VENOUS PRESSURES AND CLOTTED LINES WITH BLOOD UNABLE TO BE RETURNED. THERE WERE NO PROBLEM WITH ACCESS OR LINES PREVIOUSLY. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT RECEIVED TO DATE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25284298 ↗
• MalfunctionMay 22, 2026Fluid/Blood Leak

  A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS THAT A COMBISET BLOODLINE WAS FOUND TO HAVE A TEAR IN IT WHILE BEING USED. ADDITIONAL INFORMATION WAS OBTAINED THROUGH FOLLOW-UP WITH THE BIOMED AND THE FACILITY ADMINISTRATOR (FA) FROM THE USER FACILITY. IT WAS CONFIRMED THAT A TEAR WAS FOUND IN THE BLOODLINE AFTER BLOOD WAS SEEN LEAKING FROM THE BLOOD PUMP AREA. IT WAS UNKNOWN IF THERE WERE ANY ALARMS FROM THE 2008T MACHINE. IT WAS UNKNOWN HOW MUCH BLOOD LOSS THERE WAS. IT WAS CONFIRMED THERE WAS NO PATIENT SERIOUS INJURY, NO ADVERSE EFFECTS WERE EXPERIENCED, AND NO MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THE REPORTED EVENTS. THE PATIENT WAS SET UP WITH NEW SUPPLIES ON THE MACHINE IN USE AND THEY WERE ABLE TO COMPLETE TREATMENT WITHOUT FURTHER INCIDENT. WHEN THE BLOODLINE WAS REMOVED, A TEAR WAS IDENTIFIED ON THE BLOOD PUMP SEGMENT OF THE COMBISET. NO PHOTOS OF THE REPORTED DAMAGE COULD BE PROVIDED. THE MACHINE WAS REMOVED FROM SERVICE AND THEN EVALUATED BY THE BIOMED. THE BIOMED SAID THE BLOOD PUMP ROTOR WAS FOUND TO BE IN GOOD CONDITION. THEY WERE UNABLE TO FIND ANY ISSUES WITH THE BLOOD PUMP AND NO MACHINE PARTS HAD TO BE REPLACED. THE DAMAGED BLOODL

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25262975 ↗
• InjuryMay 21, 2026Fluid/Blood Leak

  ON 13/MAY/2026, FRESENIUS BECAME AWARE (VIA A PRODUCT COMPLAINT FORM) THIS PATIENT WITH END STAGE RENAL DISEASE (ESRD) ON HEMODIALYSIS (HD) FOR RENAL REPLACEMENT THERAPY (RRT) WAS HOSPITALIZED FOLLOWING A BLOOD LOSS EVENT DURING HD THERAPY ON (B)(6) 2026. THE PRODUCT COMPLAINT FORM STATED THE NEW SMALL TRANSDUCER PROTECTOR (ATTACHED TO THE COMBISET BLOODLINE 2500) SEPARATED FROM THE TUBING CONNECTED TO THE VENOUS CHAMBER RESULTING IN SYSTEM SEPARATION, PATIENT BLOOD LOSS, AND HOSPITALIZATION. STAFF MEMBERS ARE REPORTING INCREASED VENOUS PRESSURES AND BLOOD BACKING UP THROUGH THE TUBING TO THE TRANSDUCER PROTECTOR. DURING FOLLOW-UP, THE PATIENT¿S CHARGE NURSE (CN) CONFIRMED THE PATIENT SUFFERED A BLOOD LOSS EVENT ON (B)(6) 2026. THE CN REPORTED THE PATIENT ARRIVED FOR THEIR REGULARLY SCHEDULED HD TREATMENT WITHOUT ANY REPORTED ISSUES. THE TREATMENT WAS INITIATED, AND AFTER APPROXIMATELY 8 MINUTES INTO THERAPY THERE WAS AN EXTRACORPOREAL CIRCUIT SEPARATION BETWEEN THE VENOUS TRANSDUCER AND THE VENOUS CHAMBER TUBING RESULTING IN AN ESTIMATED BLOOD LOSS OF 500 ML (NO MACHINE ALARM OCCURRED). THE TRANSDUCER REMAINED SEATED IN THE MACHINE; HOWEVER, THE VENOUS TUBING SPONTANEOUSLY SEPARAT

  Patient problems: Chest Pain; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25243718 ↗
• MalfunctionMay 4, 2026Fluid/Blood Leak

  A USER FACILITY REPORTED THAT A COMBISET BLOODLINE HAD A SMALL HOLE IN THE ARTERIAL PUMP HOUSING SEGMENT THAT ALLOWED AIR TO ENTER THE SYSTEM DURING A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. IT WAS ALSO REPORTED THAT THE PATIENT EXPERIENCED BLOOD LOSS. THE MACHINE DID NOT ALARM. THE COMPLAINT DEVICE WAS REPORTED TO BE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. ADDITIONAL INFORMATION REQUESTED BUT TO DATE HAS NOT BEEN OBTAINED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25068424 ↗
• MalfunctionApr 28, 2026Fluid/Blood Leak

  A USER FACILITY CLINIC MANAGER (CM) REPORTED THE COMBISET HEPARIN LINE BECAME UNATTACHED FROM BLOOD TUBING AT THE CONNECTION SITE. UPON FOLLOW-UP, THE CM STATED A HEMODIALYSIS (HD) PATIENT WAS TWENTY MINUTES INTO DIALYSIS TREATMENT ON A FRESENIUS 2008T MACHINE WHEN THE MACHINE PROMPTED WITH AN AIR LEAK DETECTED MESSAGE, AND STAFF NOTICED THE HEPARIN LINE WAS ON THE FLOOR IN A POOL OF BLOOD. THE CM STATED PER FACILITY PROTOCOL THE HEPARIN LINES ARE NOT USED, ARE TIRED IN A KNOT AND CLAMPED OFF. TREATMENT WAS IMMEDIATELY HALTED. THE CM STATED THE MACHINE WAS NOT AFFECTED OR REMOVED FROM SERVICE AS THE LEAK WAS OBSERVED FROM THE DISCONNECTED TUBING ITSELF. NO FURTHER DAMAGE AND/OR DEFECTS WERE NOTED. THE CM STATED THE MACHINE 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 CM STATED BLOOD FROM THE VENOUS SIDE WAS UNABLE TO BE RETURNED. THE CM STATED THAT THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS BETWEEN 250-300 ML. THE CM STATED THERE WAS NO PATIENT INJURY, ADVERSE EVENTS, OR MEDICAL INTERVENTION REQUIRED AS A

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25018942 ↗
• MalfunctionApr 24, 2026Fluid/Blood Leak

  A USER FACILITY CLINIC MANAGER (CM) REPORTED DURING HEMODIALYSIS (HD) PATIENT TREATMENT THE HEPARIN BLOOD LINES BROKE (DETACHED) AND CAUSED BLOOD LOSS. THE ESTIMATED BLOOD LOSS (EBL) WAS UNKNOWN. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT RECEIVED TO DATE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24975794 ↗