CombiSet 03-2722-9Recalls & reported problems

Summary

The FDA's MAUDE database contains 311 adverse event reports that list this exact device (DI 00840861100293), received between Nov 12, 2015 and Sep 24, 2026 — classified as 8 deaths, 15 injuries, 288 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (289 reports).

2 other recalls cover devices cleared under the same FDA submission (K962081); 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 311 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Fluid/Blood Leak

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50889728 ↗
• MalfunctionMay 21, 2026Crack; Fluid/Blood Leak

  A SUPPLIES DIRECTOR REPORTED THAT DURING HEMODIALYSIS (HD) TREATMENT A BLOOD LINE WAS CRACKED ON THE T OF THE HEPARIN LINE. IN A FOLLOW UP, THE REPORTER SAID THE EVENT TOOK PLACE DURING A TREATMENT. THE TREATMENT WAS STOPPED AND THE PATIENT WAS DISCONNECTED. THE MACHINE AND SET UP WAS PULLED ASIDE AND THEN THE PATIENT'S TREATMENT WAS RESUMED WITH A NEW MACHINE AND SET UP.THERE WAS MINOR BLOOD LOSS BUT PATIENT WAS STABLE. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO NEW DATA WAS RECEIVED.THERE IS NO SAMPLE TO RETURN.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25243716 ↗
• MalfunctionApr 11, 2026Fluid/Blood Leak

  A USER FACILITY PROGRAM MANAGER (PM) REPORTED THAT A COMBI SET BLOODLINE LEAKED AT THE INITIATION OF A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. ADDITIONAL DETAILS WERE PROVIDED UPON FOLLOW-UP WITH THE PM AND A NURSE FROM THE FACILITY. BLOOD WAS OBSERVED LEAKING FROM THE ARTERIAL END OF THE TUBING, JUST BELOW THE MALE ADAPTER. THERE WERE NO VISIBLE DEFECTS NOTED AT THE LEAK LOCATION. ADDITIONALLY, IT WAS CONFIRMED THERE WERE NO LOOSE CONNECTIONS. THERE WERE NO ALARMS FROM THE MACHINE, A FRESENIUS 2008T MACHINE. NO LEAK WAS NOTED DURING THE PRIME, AND THERE WAS NO CHANGE OR DISRUPTION IN PRESSURE THAT COULD HAVE CONTRIBUTED TO THE LEAK. THE LINES WERE CLAMPED AND THE PATIENT¿S BLOOD WAS ABLE TO BE RETURNED. ESTIMATED BLOOD LOSS (EBL) FROM THE LEAK WAS 5ML. 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 RETURNED FOR EVALUATION AS IT WAS REPORTEDLY DISCARDED. HOWEVER, A PHOTO OF THE SAMPLE WAS PROVIDED FOR REVIEW.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24849318 ↗
• MalfunctionApr 11, 2026Fluid/Blood Leak

  A CORPORATE INVENTORY MANAGER REPORTED TO FRESENIUS THAT A COMBI SET BLOOD LEAK OCCURRED AT A HEMODIALYSIS (HD) USER CLINIC. ADDITIONAL INFORMATION WAS OBTAINED THROUGH FOLLOW-UP WITH THE FACILITY ADMINISTRATOR (FA) AND A PATIENT CARE TECHNICIAN (PCT) FROM THE CLINIC. IT WAS REPORTED THAT THE SALINE LINE SEPARATED AT THE END OF A PATIENT¿S HD TREATMENT, AS THEIR BLOOD WAS BEING REINFUSED. THE SALINE LINE SEPARATED FROM THE ¿T¿ CONNECTOR. THE PCT WAS AT THE STATION WHEN THIS OCCURRED, AND THEY WERE ABLE TO IMMEDIATELY CLAMP OFF THE LINES ONCE THEY NOTICED THE ISSUE. THERE WERE NO ALARMS FROM THE MACHINE. THERE DID NOT APPEAR TO BE ANY LOOSE CONNECTIONS LEADING UP TO THE EVENT, AND NO LEAKS WERE NOTICED DURING THE PRIMING PHASE. ADDITIONALLY, THERE WERE NO CHANGES OR DISRUPTIONS IN PRESSURE THAT COULD HAVE CONTRIBUTED TO THE FAILURE. IT WAS REPORTED THAT THE PATIENT¿S TREATMENT WAS COMPLETED. ONLY A DROP OF BLOOD LEAKED OUT. PER THE PCT, THE ESTIMATED BLOOD LOSS (EBL) WAS MAYBE 1ML. IT WAS CONFIRMED THAT 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 COMBI SET WAS NOT AVAILABLE

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24849061 ↗
• MalfunctionFeb 17, 2026Fluid/Blood Leak

  A USER FACILITY PROCUREMENT SPECIALIST REPORTED COMBISET HEMODIALYSIS (HD) BLOODLINE THAT SEPARATED DURING TREATMENT. UPON FOLLOW-UP, THE BIOMEDICAL TECHNICIAN (BMT) STATED IMMEDIATELY AFTER INITIATION OF THE PATIENT'S TREATMENT, A STAFF MEMBER NOTICED THE SALINE LINE HAD SEPARATED ALONG THE TUBING LINE THAT ATTACHED TO THE ARTERIAL CHAMBER. THE DETACHMENT AT THE T-JUNCTION CAUSED SALINE TO LEAK AND FOR AIR TO BE INTRODUCED INTO THE SYSTEM. THE PATIENT¿S TREATMENT WAS IMMEDIATELY HALTED AND THE PATIENT¿S BLOOD WAS NOT RETURNED. THE BMT STATED THE STAFF WAS ABLE TO PRIME THE SYSTEM WITHOUT ISSUE. THE BMT STATED THAT A FRESENIUS 2008T MACHINE AND DIALYZER WERE USED FOR TREATMENT AND CONFIRMED THAT THERE WERE NO DEFECTS OR DAMAGE SEEN ON THE MACHINE, DIALYZER OR BLOODLINES PRIOR TO THE EVENT. THE BMT STATED BLOOD LOSS WAS REPORTED BUT THE PATIENT'S ESTIMATED BLOOD LOSS (EBL) WAS UNKNOWN. IMMEDIATELY FOLLOWING THE EVENT, THE PATIENT WAS RE-SETUP WITH NEW SUPPLIES ON THE SAME MACHINE WHERE THE PATIENT WAS ABLE TO COMPLETE TREATMENT WITHOUT FURTHER ISSUE. THE BMT CONFIRMED THAT THERE WAS NO PATIENT INJURY, ADVERSE EVENTS, OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THE REPORTED EVENT

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24368728 ↗
• MalfunctionDec 12, 2025Obstruction of Flow; Obstruction of Flow

  A USER FACILITY¿S CERTIFIED CLINICAL HEMODIALYSIS TECHNICIAN (CCHT) REPORTED THAT A FRESENIUS COMBISET BLOODLINE¿S ARTERIAL LINE BENT INSIDE THE PORT DURING A PATIENT¿S HEMODIALYSIS (HD) TREATMENT RESULTING IN BLOOD LOSS. THE ISSUE OCCURRED TEN MINUTES AFTER THE INITIATION OF THE PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE MACHINE, A FRESENIUS 2008T MACHINE, ALARMED WITH A HIGH ARTERIAL PRESSURE ALARM DUE TO A PATIENT CATHETER ISSUE. THE CCHT REVERSED THE CVC LINES AND THE LINE INSIDE THE PORT BENT AND SHE WAS NO LONGER ABLE TO ACCESS THE ARTERIAL PORT. THEY WERE UNABLE TO RINSE BACK THE ARTERIAL LINE. 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 WAS RESTARTED ON THE SAME MACHINE AND TREATMENT COMPLETED SUCCESSFULLY WITH NEW SUPPLIES. A FRESENIUS DIALYZER WAS ALSO IN USE. THE COMPLAINT DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23789518 ↗
• MalfunctionDec 1, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY REGISTERED NURSE (RN) REPORTED THAT A COMBI SET BLOOD LEAK OCCURRED DURING A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. ADDITIONAL DETAILS WERE PROVIDED UPON FOLLOW-UP WITH A CHARGE NURSE (CN) FROM THE FACILITY. THE CN STATED THE BLOOD LEAK OCCURRED APPROXIMATELY TWO HOURS INTO THE TREATMENT. THE MACHINE, A FRESENIUS 2008T MACHINE, WAS ALARMING WITH AN AIR DETECTOR MESSAGE. WHEN THEY INSPECTED THE SETUP, THEY NOTICED THERE WAS AIR IN THE VENOUS CHAMBER, AND BLOOD WAS LEAKING FROM THE COMBI SET. UPON FURTHER INSPECTION, THEY NOTICED THERE WAS A SMALL HOLE IN THE BLOOD PUMP TUBING. THE BLOOD LEAK WAS COMING FROM THE SMALL HOLE, AND IT WAS DETERMINED THAT THE AIR HAD ENTERED THE CIRCUIT AT THE HOLE. AFTER THE LEAK WAS IDENTIFIED, THE TREATMENT WAS STOPPED. THE PATIENT¿S BLOOD WAS NOT RETURNED; 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 RETURNED FOR MANUFACTURER EVALUATION AS IT WAS

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23688793 ↗
• MalfunctionOct 8, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY NURSE MANAGER (NM) REPORTED THAT A COMBI SET BLOOD LEAK OCCURRED APPROXIMATELY EIGHTY-FOUR MINUTES INTO A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THERE WERE TWO SMALL DROPS OF BLOOD NOTED ON THE BASE OF THE MACHINE. THE BLOOD LEAK WAS COMING FROM THE PORTION OF THE TUBING THAT IS PLACED INSIDE THE BLOOD PUMP. THERE WAS A SMALL PINHOLE OBSERVED AT THE CENTER OF THE TUBING. BLOOD FROM THE ARTERIAL LINE WAS RETURNED. BLOOD FROM THE VENOUS LINE COULD NOT BE RETURNED. THE PATIENT'S ESTIMATED BLOOD LOSS WAS 200ML. THERE WERE NO MACHINE ALARMS. NO DAMAGE OR DEFECTS WERE NOTED ON THE LINES PRIOR TO USE, AND NO LOOSE CONNECTIONS WERE NOTICED. THE NM CONFIRMED THERE WERE NO LEAKS DURING THE PRIMING PHASE. THERE WERE NO CHANGES OR DISRUPTIONS IN PRESSURE THAT COULD HAVE CONTRIBUTED TO THE LEAK. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE MEDICAL INTERVENTION DUE TO THE BLOOD LOSS. THE PATIENT WAS RE-SETUP WITH NEW SUPPLIES AND COMPLETED THEIR TREATMENT ON THE SAME MACHINE. THE BLOOD PUMP WAS INSPECTED FOLLOWING THE EVENT AND NO SHARP EDGES WERE NOTED. THE COMBI SET WAS NOT AVAILABLE TO BE RETURNED FOR EVALUATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23251435 ↗
• MalfunctionOct 8, 2025Fluid/Blood Leak; Obstruction of Flow; Fluid/Blood Leak; Obstruction of Flow

  A USER FACILITY NURSE MANAGER (NM) REPORTED THAT A COMBI SET BLOOD LEAK OCCURRED NINETY MINUTES INTO A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. IT WAS NOT SPECIFIED WHERE EXACTLY THE LEAK WAS COMING FROM. FOLLOWING THE EVENT, IT WAS REPORTED THAT VISIBLE DAMAGE WAS IDENTIFIED ON THE COMBI SET LINES. HOWEVER, THE LOCATION OF THE DAMAGE OR DEFECT WAS NOT SPECIFIED. THE TREATMENT COULD NOT BE RESUMED DUE TO A CLOTTED VENOUS LINE. THE PATIENT¿S ESTIMATED BLOOD LOSS DUE TO THE EVENT WAS 200ML. IT WAS UNKNOWN IF THERE WERE ANY MACHINE ALARMS. NO DAMAGE OR DEFECTS WERE NOTED ON THE LINES PRIOR TO USE, AND NO LOOSE CONNECTIONS WERE NOTICED. THE NM CONFIRMED THERE WERE NO LEAKS DURING THE PRIMING PHASE. THERE WERE NO CHANGES OR DISRUPTIONS IN PRESSURE THAT COULD HAVE CONTRIBUTED TO THE LEAK. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE MEDICAL INTERVENTION DUE TO THE BLOOD LOSS. THE PATIENT CHOSE NOT TO CONTINUE THEIR TREATMENT, AND THEY WERE NOT RE-SETUP WITH NEW SUPPLIES. THE COMBI SET WAS NOT AVAILABLE TO BE RETURNED FOR EVALUATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23251434 ↗
• DeathOct 3, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS TECHNICAL SUPPORT THAT AN UNSPECIFIED PATIENT INCIDENT OCCURRED DURING A PATIENT¿S HEMODIALYSIS (HD) TREATMENT ON A FRESENIUS 2008T HD MACHINE. THE BIOMED WAS REQUESTING THE MACHINE BE INSPECTED BY A FIELD SERVICE TECHNICIAN (FST). AN FST WAS DISPATCHED TO THE FACILITY TO PERFORM FUNCTIONAL TESTING ON THE MACHINE. THE MACHINE PASSED ALL POST-EVENT FUNCTIONAL COMPLIANCE TESTING. THE FST REPORTEDLY HEARD THAT THE PATIENT MAY HAVE PULLED OUT THEIR ACCESS LINE AND BLED OUT. THROUGH ADDITIONAL FOLLOW-UP WITH THE BIOMED AND A REGISTERED NURSE (RN) FROM THE FACILITY, IT WAS REVEALED THAT THE PATIENT EXPERIENCED BLOOD LOSS DURING HD TREATMENT AND SUBSEQUENTLY EXPIRED. FURTHER DETAILS WERE PROVIDED UPON FOLLOW-UP WITH THE ACUTE FACILITY DIALYSIS UNIT MANAGER. IT WAS REPORTED THAT THIS PATIENT WAS INITIALLY HOSPITALIZED FOR REASONS UNRELATED TO RENAL REPLACEMENT THERAPY. WHEN THE PATIENT WAS PLACED ON AN HD TREATMENT UTILIZING A HOSPITAL PROVIDED FRESENIUS COMBI SET BLOODLINE, THE PATIENT¿S ACCESS WAS PROPERLY SECURED BY HEMACLIP CONNECTING CLIPS TO THE BLOODLINES. WHEN THE RN RETURNED TO THE PATIENT¿S ROOM (EXACT TIME IN T

  Patient problems: Exsanguination; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23213110 ↗
• MalfunctionSep 30, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY NURSE MANAGER (NM) REPORTED THAT A COMBI SET BLOOD LEAK OCCURRED DURING A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE COMBI SET REPORTEDLY ¿SPLIT IN TWO¿. THE PATIENT¿S BLOOD COULD NOT BE RETURNED. ADDITIONAL DETAILS WERE PROVIDED UPON FOLLOW-UP WITH THE NM. WITH TWO HOURS AND SIX MINUTES REMAINING IN THE TREATMENT, AN AIR DETECTOR ALARM WENT OFF. THE STAFF INSPECTED THE LINES AND NOTICED A SMALL AMOUNT OF BLOOD LEAKING FROM THE COMBI SET BETWEEN THE ARTERIAL LINE AND BLOOD PUMP. NO FURTHER EXPLANATION WAS PROVIDED ON WHAT WAS MEANT BY ¿SPLIT IN TWO¿. THE NM CONFIRMED THE COMBI SET WAS INSPECTED FOR DAMAGE PRIOR TO USE, AND THAT NO DAMAGE OR DEFECT WAS NOTED AT THAT TIME. NOTHING NOTEWORTHY OCCURRED DURING THE PRIME. THERE WERE NO CHANGES OR DISRUPTIONS IN PRESSURE THAT COULD HAVE CONTRIBUTED TO THE LEAK. THERE WERE NO LOOSE CONNECTIONS NOTED ON THE COMBI SET LINES. THE PATIENT'S ESTIMATED BLOOD LOSS (EBL) DUE TO THE EVENT WAS 200ML. FOLLOWING THE LEAK, THE PATIENT HAD THEIR HEMOGLOBIN CHECKED. THE PATIENT WAS RE-SETUP WITH NEW SUPPLIES AND COMPLETED THEIR TREATMENT ON THE SAME MACHINE. THE PATIENT TOLERATED THE TREATMENT WELL, AND AGREED TO HAVE THEIR HEMOGLOBIN REC

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23183795 ↗
• MalfunctionAug 21, 2025Obstruction of Flow; Obstruction of Flow

  A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS CUSTOMER SERVICE THAT THE ARTERIAL CHAMBER OF A COMBI SET BLOODLINE CLOTTED TOWARDS THE END OF A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THERE WAS NO REPORT OF THE EVENT RESULTING IN ANY SERIOUS PATIENT INJURY. THE AMOUNT OF BLOOD LOSS DUE TO THE CLOTTING WAS NOT REPORTED. THE BIOMED WAS REQUESTING THE REMAINDER OF BLOODLINES FROM THIS LOT BE REPLACED. THE ACTUAL 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 22869307 ↗
• MalfunctionAug 21, 2025Obstruction of Flow; Obstruction of Flow

  A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS CUSTOMER SERVICE THAT THE ARTERIAL CHAMBER OF A COMBI SET BLOODLINE CLOTTED TOWARDS THE END OF A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THERE WAS NO REPORT OF THE EVENT RESULTING IN ANY SERIOUS PATIENT INJURY. THE AMOUNT OF BLOOD LOSS DUE TO THE CLOTTING WAS NOT REPORTED. THE BIOMED WAS REQUESTING THE REMAINDER OF BLOODLINES FROM THIS LOT BE REPLACED. THE ACTUAL 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 22867391 ↗
• MalfunctionAug 8, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A CORPORATE INVENTORY MANAGER REPORTED TO FRESENIUS THAT A COMBI SET BLOOD LEAK OCCURRED AT A HEMODIALYSIS (HD) USER FACILITY. ADDITIONAL INFORMATION WAS OBTAINED THROUGH FOLLOW-UP WITH A REGISTERED NURSE (RN) / ASSISTANT CLINIC MANAGER FROM THE FACILITY. TWO HOURS AND SEVEN MINUTES INTO A PATIENT'S HD TREATMENT, IT WAS NOTED THAT BLOOD WAS LEAKING FROM THE COMBI SET TUBING WITHIN THE BLOOD PUMP. THERE WERE NO ALARMS FROM THE MACHINE, A FRESENIUS 2008T MACHINE. THERE WERE NO KNOWN ISSUES LEADING UP TO THE EVENT, INCLUDING ANY LEAKS DURING THE PRIME. THERE WAS NO INDICATION THAT THE LINES WERE DAMAGED WHEN THEY WERE REMOVED FROM THE MACHINE. IT WAS REPORTED THAT THE PATIENT'S BLOOD WAS COMPLETELY RETURNED ONCE THE LEAK WAS IDENTIFIED. ESTIMATED BLOOD LOSS (EBL) FROM THE LEAK ITSELF WAS LESS THAN 50 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 TREATMENT AFTER BEING RE-SETUP WITH NEW SUPPLIES ON THE SAME MACHINE. THE COMBI SET BLOODLINE WAS NOT AVAILABLE TO BE RETURNED FOR EVALUATION AS IT WAS REPORTEDLY DISCARDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22755723 ↗
• MalfunctionJul 8, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE DIRECTOR OF NURSING (DN) FROM A HEMODIALYSIS (HD) USER FACILITY REPORTED THAT A BLOOD LEAK OCCURRED DURING A PATIENT¿S HD TREATMENT. THE BLOOD LEAK WAS NOTED TO BE COMING FROM THE BLOOD PUMP. ACCORDING TO THE NURSE OPERATING THE MACHINE, IT SEEMED LIKE THE BLOODLINE TUBING MAY HAVE ¿ERUPTED¿. ADDITIONAL DETAILS WERE OBTAINED THROUGH FOLLOW-UP WITH THE DN, AS WELL AS THE HEAD BIOMEDICAL TECHNICIAN (BIOMED). AN ALARM FOR LOW BLOOD PRESSURE WAS WHAT INITIALLY DREW THE STAFF¿S ATTENTION. AT APPROXIMATELY THIRTY-TWO MINUTES INTO THE TREATMENT, THE OPERATING NURSE NOTICED BLOOD DRIPPING FROM THE BLOOD PUMP. THERE WAS NO BLOOD PUMP ALARM. THE BLOOD LEAK RESULTED IN AN ESTIMATED BLOOD LOSS (EBL) OF 200 ML. PER STANDING ORDERS, THE PATIENT WAS GIVEN A SALINE BOLUS (VOLUME UNSPECIFIED) TO ADDRESS THE LOW BLOOD PRESSURE (BP). THE PATIENT¿S BP INITIALLY WENT UP FOLLOWING ADMINISTRATION OF THE BOLUS. THE PATIENT WAS RE-SETUP WITH NEW SUPPLIES ON A DIFFERENT MACHINE WHERE THEY WERE ABLE TO COMPLETE TREATMENT. THEY CONTINUED TO MONITOR THE PATIENT¿S BP THROUGHOUT THE TREATMENT. APPROXIMATELY AN HOUR AFTER RESTARTING THE TREATMENT, THE PATIENT COMPLAINED OF NAUSEA AND BEGAN VOMITING. DESPITE T

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Nausea; Vomiting

  MAUDE report 22439250 ↗
• MalfunctionJun 2, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY INVENTORY MANAGER REPORTED A COMIBISET BLOODLINE LEAK. UPON FOLLOW-UP, THE FACILITY ADMINISTRATOR (FA) REPORTED A HEMODIALYSIS (HD) PATIENT WAS 90 MINUTES INTO DIALYSIS TREATMENT ON A FRESENIUS 2008T MACHINE WHEN THE MACHINE PROMPTED WITH AN AIR LEAK DETECTED MESSAGE, AND STAFF NOTICED BLOOD DRIPPING FROM THE BLOOD PUMP SECTION OF THE DIALYSIS TUBING ON THE DIALYSIS MACHINE. TREATMENT WAS HALTED AND THE STAFF REPORTED A 0.5CM VISIBLE CRACK IN THE LINE OF THE TUBING. THE FA CONFIRMED THAT THE MACHINE WAS NOT AFFECTED OR REMOVED FROM SERVICE AS THE LEAK WAS OBSERVED FROM THE TUBING. NO FURTHER DAMAGE AND/OR DEFECTS WERE NOTED. A FRESENIUS 180NRE DIALYZER WAS USED FOR TREATMENT AND THE PATIENT'S BLOOD WAS ABLE TO BE RETURNED. THE FA STATED THAT THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS MINIMAL AND LESS THAN 10CC. THE FA CONFIRMED THERE WAS NO PATIENT INJURY, ADVERSE EVENTS, OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THE REPORTED EVENT. THE PATIENT WAS RESTARTED ON THE SAME MACHINE AND TREATMENT COMPLETED SUCCESSFULLY WITH NEW TUBING LINES WITHOUT FURTHER ISSUE. FOLLOWING TREATMENT, THE BIOMEDICAL TECHNICIAN EXAMINED THE MACHINE BLOOD PUMP ROTOR AND NO ISSUES WE

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22127525 ↗
• MalfunctionMay 20, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE NURSE ADMINISTRATOR FROM A USER FACILITY REPORTED THAT A COMBI SET BLOOD LEAK OCCURRED DURING A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE LEAK WAS CAUSED BY A DETACHMENT OF THE COMBI SET LINE FROM THE PATIENT¿S DIALYSIS ACCESS (NOT A FRESENIUS PRODUCT). IT IS UNKNOWN HOW MUCH BLOOD LOSS THIS RESULTED IN, OR IF THE PATIENT WAS ABLE TO COMPLETE THEIR TREATMENT. THERE WERE NO ALLEGATIONS MADE THAT THE EVENT RESULTED IN ANY SERIOUS PATIENT INJURY OR THE NEED FOR MEDICAL INTERVENTION. 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 22054636 ↗
• MalfunctionMay 20, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE NURSE ADMINISTRATOR FROM A USER FACILITY REPORTED THAT A COMBI SET BLOOD LEAK OCCURRED DURING A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE LEAK WAS CAUSED BY A DETACHMENT OF THE COMBI SET LINE FROM THE PATIENT¿S DIALYSIS ACCESS (NOT A FRESENIUS PRODUCT). IT IS UNKNOWN HOW MUCH BLOOD LOSS THIS RESULTED IN, OR IF THE PATIENT WAS ABLE TO COMPLETE THEIR TREATMENT. THERE WERE NO ALLEGATIONS MADE THAT THE EVENT RESULTED IN ANY SERIOUS PATIENT INJURY OR THE NEED FOR MEDICAL INTERVENTION. 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 22054635 ↗
• MalfunctionMay 20, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE NURSE ADMINISTRATOR FROM A USER FACILITY REPORTED THAT A COMBI SET BLOOD LEAK OCCURRED DURING A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE LEAK WAS CAUSED BY A DETACHMENT OF THE COMBI SET LINE FROM THE PATIENT¿S DIALYSIS ACCESS (NOT A FRESENIUS PRODUCT). IT IS UNKNOWN HOW MUCH BLOOD LOSS THIS RESULTED IN, OR IF THE PATIENT WAS ABLE TO COMPLETE THEIR TREATMENT. THERE WERE NO ALLEGATIONS MADE THAT THE EVENT RESULTED IN ANY SERIOUS PATIENT INJURY OR THE NEED FOR MEDICAL INTERVENTION. 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 22054634 ↗
• InjuryMay 13, 2025Fluid/Blood Leak; Fluid/Blood Leak

  ON 16/APR/2025 FRESENIUS WAS NOTIFIED OF A VENOUS LINE SEPARATION FROM THE NEEDLE WHILE UTILIZING THE CUSTOM COMBI SET ON (B)(6) 2025. ADDITIONAL INFORMATION WAS OBTAINED THROUGH FOLLOW-UP WITH THE CLINICAL MANAGER (CM). THIS MALE HEMODIALYSIS (HD) PATIENT ARRIVED FOR A REGULARLY SCHEDULED HD TREATMENT ON (B)(6) 2025. TREATMENT WAS SCHEDULED FOR A TOTAL OF FOUR HOURS. THE TREATMENT WAS INITIATED AT 8:09AM UTILIZING A FRESENIUS 2008T MACHINE AND COMBI SET BLOODLINES. THE BLOOD FLOW RATE WAS 400ML/MIN AND THE DIALYSATE FLOW RATE WAS SET FOR 1.5X AUTOFLOW. NINE MINUTES INTO THE PATIENT¿S TREATMENT, BLOOD WAS NOTED ON THE FLOOR. THE ESTIMATED BLOOD LOSS WAS APPROXIMATELY 600ML. THE MACHINE DID NOT ALARM BUT WAS NOT EXPECTED TO ALARM. THE CONNECTION AT THE VENOUS LINE AND NEEDLE WAS NOTED TO BE COMPLETELY SEPARATED. THE TREATMENT WAS DISCONTINUED. THE PATIENT¿S BLOOD WAS RINSED BACK. THE PATIENT EXPERIENCED AGONAL BREATHING AND WAS SUPPORTED BY RESCUE BREATHS UTILIZING AMBU BAG. 911 WAS CALLED AND THE PATIENT WAS TRANSPORTED TO THE HOSPITAL VIA EMERGENCY MEDICAL SERVICES (EMS). THE PATIENT WAS TRANSFUSED WITH 2 UNITS OF PACKED RED BLOOD CELLS (PRBC). THE PATIENT WAS DISCHARGED ON (B)(6)

  Patient problems: Dyspnea; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22011872 ↗
• MalfunctionMay 6, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE CLINIC MANAGER (CM) REPORTED TO FRESENIUS THAT A BLOOD LEAK OCCURRED WITH THE CUSTOM COMBISET BLOODLINES DURING THE PATIENT'S HEMODIALYSIS (HD) TREATMENT. THE CM STATED THAT "BLOOD WAS DRIPPING FROM THE JUNCTION OF THE HEPARIN LINE WHERE IT ENTERS THE BLOOD LINES AT THE RED CONNECTION." ADDITIONAL INFORMATION WAS OBTAINED DURING FOLLOW-UP. THE REPORTED ISSUE WAS DISCOVERED APPROXIMATELY 10 MINUTES AFTER TREATMENT INITIATION ON THE 2008T MACHINE. NO MACHINE ALARMS WERE RECEIVED. THE ISSUE WAS IDENTIFIED UPON VISUAL OBSERVATION OF DRIPPING BLOOD. THE CM STATED THAT THE HEPARIN LINE DID NOT DISCONNECT. THERE WERE NO LEAKS ENCOUNTERED DURING PRIME. THE PATIENT ALSO DID NOT REQUIRE A HEPARIN PUMP. THERE WERE NO SERIOUS INJURIES OR ADVERSE EFFECTS TO THE PATIENT. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) IS APPROXIMATELY 20-30 ML. TREATMENT WAS RESTARTED AND COMPLETED ON A NEW MACHINE WITH NEW SUPPLIES. THE SAMPLE WAS DISCARDED AND IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21968790 ↗
• MalfunctionMay 2, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY¿S INVENTORY MANAGER REPORTED THAT A FRESENIUS BLOODLINE LEAKED 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. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT RECEIVED TO DATE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21955465 ↗
• MalfunctionApr 30, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY BIOMEDICAL TECHNICIAN REPORTED THAT THE TUBING ON A COMBI SET ¿BROKE¿ DURING A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. ADDITIONAL CLARIFICATION WAS OBTAINED THROUGH FOLLOW-UP WITH A REGISTERED NURSE (RN) FROM THE FACILITY. THE RN REPORTED THAT A BLOOD LEAK WAS OBSERVED COMING FROM THE COMBI SET LESS THAN FIVE MINUTES AFTER THE START OF TREATMENT. BLOOD WAS OBSERVED LEAKING EXTERNALLY FROM THE ¿T¿ CONNECTION ON THE ARTERIAL SIDE OF THE LINES, WHERE THE HEPARIN LINE CONNECTS. THE HEPARIN LINE REMAINED INTACT ACCORDING TO THE RN; IT DID NOT SEPARATE OR DISCONNECT. THERE WERE NO VISIBLE DEFECTS NOTED AT THE LEAK LOCATION. THE RN STATED THERE WAS NO LEAKING NOTED DURING THE PRIMING PHASE. ADDITIONALLY, THERE WERE NO ALARMS FROM THE MACHINE. ONCE THE LEAK WAS NOTICED, THE PATIENT¿S BLOOD WAS RETURNED. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) FROM THE LEAK WAS LESS THAN 20 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 TREATMENT AFTER BEING RE-SETUP WITH NEW SUPPLIES ON THE SAME MACHINE. THE SAMPLE WAS CONFIRMED TO BE AVAILA

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21939946 ↗
• MalfunctionApr 21, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED TO FRESENIUS THAT A COMBI SET BLOOD LEAK OCCURRED DURING A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. ADDITIONAL DETAILS WERE OBTAINED THROUGH FOLLOW-UP WITH THE USER FACILITY¿S TECHNICAL MANAGER. THE BLOOD LEAK WAS REPORTEDLY CAUSED BY A SEPARATION ON THE ARTERIAL SIDE OF THE BLOODLINE. THE LINE THAT SEPARATED WAS REPORTEDLY LACKING ADHESIVE AT THE CONNECTION. THE TECHNICAL MANAGER STATED THE BLOOD LEAK WAS NOTED FORTY-FIVE MINUTES INTO THE PATIENT¿S TREATMENT. THE PATIENT CARE TECHNICIAN (PCT) WAS CHECKING THE PATIENT'S BLOOD PRESSURE WHEN THE LEAK WAS NOTICED. THERE WERE NO MACHINE ALARMS. THERE WERE NO LEAKS DURING THE PRIMING PHASE. FOLLOWING THE LEAK, THE PATIENT'S BLOOD WAS REPORTEDLY RETURNED. THE PATIENT'S ESTIMATED BLOOD LOSS (EBL) DUE TO THE EVENT WAS 100 TO 200 ML. THE MACHINE WAS RE-SETUP WITH NEW SUPPLIES AND THE PATIENT THEN COMPLETED THEIR TREATMENT. 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 SAMPLE WAS NOT AVAILABLE TO BE RETURNED FOR MANUFACTURER EVALUATION AS IT WAS REPORTEDLY DISCARDED. HOWEVER, A PHOTO OF THE COMPLAINT DEVICE DEPICTING THE

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21876938 ↗
• MalfunctionApr 18, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY BIOMEDICAL TECHNICIAN REPORTED THAT A COMBI SET BLOOD LEAK OCCURRED DURING A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. ADDITIONAL DETAILS WERE OBTAINED THROUGH FOLLOW-UP WITH THE FACILITY¿S CLINICAL MANAGER (CM). THE CM STATED THE BLOOD LEAK WAS NOTICED APPROXIMATELY THREE HOURS INTO THE TREATMENT. BLOOD WAS OBSERVED DRIPPING FROM THE ¿T¿ CONNECTOR, WHERE THE SKINNY HEPARIN LINE CONNECTS TO THE HARD PLASTIC PIECE. THERE WERE NO ALARMS FROM THE MACHINE. THERE WERE NO VISIBLE DEFECTS AT THE LEAK LOCATION, AND THE HEPARIN LINE APPEARED TO BE PROPERLY SEATED IN THE CONNECTOR COMPONENT. THE CM STATED THERE WERE NO KNOWN LOOSE CONNECTIONS. AFTER THE STAFF NOTICED THE LEAK, THE PATIENT¿S BLOOD WAS RETURNED AND THE TREATMENT WAS ENDED EARLY. THE PATIENT¿S BLOOD LOSS WAS REPORTEDLY MINIMAL; ESTIMATED BLOOD LOSS (EBL) WAS LESS THAN 25 ML. THE CM 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 DID NOT COMPLETE THEIR TREATMENT, BUT THEY DID NOT DEVELOP ANY SYMPTOMS OR ISSUES BECAUSE OF THIS. THE SAMPLE WAS NOT AVAILABLE TO BE RETURNED FOR MANUFACTURER EVALUAT

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21869544 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K962081. One submission often covers many models, so check the product and lot details in each record.

• Z-0843-2011 · Nov 19, 2010 · Terminated
  Fresenius Medical CombiSet BVM Hemodialysis Blood Tubing Set P/N: 03-2695-9
• Z-0844-2011 · Nov 19, 2010 · Terminated
  Fresenius Medical CombiSet BVM Hemodialysis Blood Tubing Set P/N: 03-2795-7