5008X HDF Hemodialysis Blood Tubing Set 03-5100-7Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00840861102365), received between Aug 2, 2024 and Jun 10, 2025 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (10 reports).

1 FDA recall record name this device's identifier, 1 still open.

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

Recalls naming this device

1. Apr 29, 2025Class IIOpen, Classified

   Potential of blood leak occurring between the lower port of the venous chamber and the tubing include: hemodiafiltration (HDF), hemodialysis (HD), hemofiltration (HF), and isolated ultrafiltration.

   Z-1992-2025 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 10, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY¿S CLINIC MANAGER (CM) REPORTED THAT 1 HOUR INTO A PATIENT'S HEMODIALYSIS (HD) TREATMENT, A FRESENIUS 5008X BLOODLINE HAD AIR IN IT. THE FRESENIUS 5008X HD MACHINE ALARMED APPROPRIATELY WITH AN ¿AIR IN LINE¿ ALARM. A FRESENIUS DIALYZER WAS ALSO IN USE. THE AIR REMOVAL PROCEDURE WAS FOLLOWED, BUT AIR CONTINUED TO APPEAR. AFTER INITIATING THE AIR REMOVAL PROCEDURE, A BLOOD LEAK WAS NOTED TO ORIGINATE FROM THE ARTERIAL PRESSURE DOME. THERE WERE NO LOOSE CONNECTIONS, NO ISSUES NOTED DURING PRIME AND NO CHANGES IN PRESSURE DURING TREATMENT. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 260ML. 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 PATIENT LOST THIRTY MINUTES OF TREATMENT DUE TO THE INTERRUPTION. THE COMPLAINT DEVICE IS AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. A PHOTO HAS BEEN PROVIDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22176245 ↗
• MalfunctionJun 3, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY¿S CLINIC MANAGER (CM) REPORTED THAT FOUR MINUTES AFTER THE INITIATION OF THE PATIENT¿S HEMODIALYSIS (HD) TREATMENT A FRESENIUS 5008X HD MACHINE DISPLAYED ¿BTM: NO LINES DETECTED OR BTM DOORS OPEN¿ AND ¿ARTERIAL PRESSURE MEASUREMENT ERROR¿ ALARMS. IT WAS NOTED THAT THERE WAS AIR THROUGHOUT THE LINES BOTH BEFORE & AFTER THE DIALYZER, INITIATING AROUND THE ARTERIAL PRESSURE POD. FRESENIUS 5008X BLOODLINES AND A FRESENIUS DIALYZER WERE IN USE. THEY ATTEMPTED TO REINFUSE THE PATIENT WITH SALINE, BUT THERE WAS TOO MUCH AIR IN THE LINES. ADDITIONALLY, IT WAS NOTED THAT BLOOD WAS DRIPPING DOWN FROM THE ARTERIAL PRESSURE DOME. THERE WERE NO LOOSE CONNECTIONS. THERE NO ISSUES NOTED DURING PRIMING. THERE WERE NO CHANGES OR DISRUPTIONS IN PRESSURE DURING TREATMENT. THERE WAS NO VISIBLE DAMAGE OR DEFECT ON THE BLOODLINE. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 200ML. THERE WAS NO PATIENT SERIOUS INJURY OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THIS EVENT. THE PATIENT CHOSE TO END THE TREATMENT TWENTY MINUTES EARLY. THE COMPLAINT DEVICES WERE REPORTED TO BE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION, BUT TRACKING NUMBERS WERE NOT AVAILABL

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22135579 ↗
• MalfunctionMay 22, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY¿S CLINICAL MANAGER (CM) REPORTED THAT A FRESENIUS 5008X BLOODLINE HAD AIR IN IT TWO AND A HALF HOURS AFTER THE INITIATION OF THE PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE MACHINE, A FRESENIUS 5008X MACHINE, ALARMED APPROPRIATELY WITH AN AIR IN LINE ALARM. THE ORIGIN OF THE LEAK IS UNKNOWN. THERE WERE NO LOOSE CONNECTIONS AND THERE WAS NO DAMAGE OR DEFECT NOTED ON THE BLOODLINE. ADDITIONALLY, THERE WERE NO CHANGES OR DISRUPTIONS IN PRESSURE DURING TREATMENT. THE CLINICIAN INITIATED THE AIR REMOVAL PROCEDURE PER POLICY VIA A 10CC SYRINGE, HOWEVER MORE & MORE AIR BEGAN APPEARING THROUGHOUT THE LINES WITH NO OBVIOUS SOURCE. THERE WAS NO INDICATION THAT THE PLUNGER BECAME DISLODGED. NO VISIBLE BLOOD WAS NOTED ON THE INSIDE WALL OF THE ARTERIAL PRESSURE MEASUREMENT DOME. AFTER PERFORMING THE AIR REMOVAL PROCEDURE PER POLICY 3 TIMES, THE AIR IN LINE ALARM CONTINUED TO APPEAR. AT THAT POINT, THE PATIENT¿S TREATMENT WAS ENDED ONE HOUR EARLY. THEIR BLOOD WAS NOT RETURNED AND 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. A FRESENIUS DIALYZER WAS IN USE. THE COMP

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22073963 ↗
• MalfunctionMay 6, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY¿S CLINIC MANAGER (CM) REPORTED THAT A FRESENIUS 5008X BLOODLINE LEAKED IMMEDIATELY AFTER THE INITIATION OF A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE LEAK ORIGINATED FROM A BROKEN CONNECTION AT THE BOTTOM OF THE VENOUS CHAMBER. THE MACHINE, A FRESENIUS 5008X MACHINE, DID NOT ALARM, BUT WAS NOT EXPECTED TO. A FRESENIUS DIALYZER WAS ALSO IN USE. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 25ML. 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 21968618 ↗
• MalfunctionMar 28, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY'S CLINICAL MANAGER (CM) REPORTED THAT A FRESENIUS BLOODLINE EXPERIENCED AIR IN THE LINE DURING A PATIENT'S HEMODIALYSIS (HD) TREATMENT RESULTING IN BLOOD LOSS. TWO HOURS AFTER THE INITIATION OF THE PATIENT¿S HD TREATMENT, A FRESENIUS 5008X MACHINE ALARMED FOR AIR IN LINES AND THE CLINICIAN BEGAN THE AIR REMOVAL PROCEDURE. THE LINES WERE PLACED INTO CIRCULATION, A SALINE BAG WAS CONNECTED, AND A SYRINGE WAS CONNECTED TO THE VENOUS CHAMBER. WHEN THE CLINICIAN INITIATED THE REMOVAL OF AIR VIA THE SYRINGE MORE AIR BEGAN APPEARING THROUGHOUT THE LINES WITH NO OBVIOUS SOURCE. THE PATIENT¿S BLOOD WAS NOT RINSED BACK FOLLOWING THE INCIDENT. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) IS 250ML. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THIS EVENT. A FRESENIUS DIALYZER WAS ALSO IN USE. THERE WAS NO DAMAGE NOTICED ON EITHER THE BLOODLINE OR THE DIALYZER. 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 21719560 ↗
• MalfunctionMar 3, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY¿S CLINIC MANAGER (CM) REPORTED THAT A 5008X STANDARD HDF BLOODLINE LEAK WAS NOTED AT THE END OF A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE BLOOD LEAK WAS VISUALLY OBSERVED AT THE CONNECTION BETWEEN THE VENOUS CHAMBER AND THE RETURN LINE. WHEN REMOVING THE LINES FROM THE MACHINE, THE JOINT BETWEEN THE VENOUS CHAMBER AND THE RETURN LINE COMPLETELY SNAPPED OFF. THE MACHINE, A FRESENIUS 2008T MACHINE, DID NOT ALARM AND WAS NOT EXPECTED TO. A FRESENIUS DIALYZER WAS ALSO IN USE. THERE WAS NO DEFECT OR DAMAGE NOTED ON THE DIALYZER. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 10ML. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THIS EVENT. THE PATIENT HAD ALREADY COMPLETED TREATMENT WHEN THE LEAK WAS NOTICED. THE COMPLAINT DEVICE WAS REPORTED TO BE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21504606 ↗
• MalfunctionFeb 28, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY CHARGE NURSE (CN) REPORTED THAT A 5008X BLOODLINE LEAK OCCURRED DURING A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE BLOOD LEAK OCCURRED MID-TREATMENT AND WAS REPORTED TO BE COMING FROM THE CONNECTION BETWEEN THE VENOUS CHAMBER AND THE LINE THAT RETURNS TO THE PATIENT. THERE WERE NO OTHER KNOWN ISSUES LEADING UP TO THE EVENT, AND THERE WERE NO LEAKS DURING THE PRIME. NO DISCONNECTION OR SEPARATION WAS NOTED AT THE LEAK LOCATION. ALL CONNECTIONS WERE CONFIRMED TO BE SECURE PRIOR TO TREATMENT INITIATION. THERE WERE NO ALARMS FROM THE MACHINE. THE MAJORITY OF THE PATIENT'S BLOOD WAS ABLE TO BE RETURNED. THE PATIENT'S ESTIMATED BLOOD LOSS (EBL) DUE TO THE LEAK WAS 10 ML. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE MEDICAL INTERVENTION DUE TO THE REPORTED EVENT. THE PATIENT WAS ABLE TO COMPLETE THEIR TREATMENT AFTER BEING RE-SETUP WITH NEW SUPPLIES ON A DIFFERENT MACHINE. FOLLOWING THE EVENT, A MACHINE EVALUATION WAS PERFORMED BY A FRESENIUS FIELD SERVICE TECHNICIAN (FST) TO VERIFY THE MACHINE WAS FUNCTIONING CORRECTLY. A REPORT SUBMITTED BY THE FST CONFIRMED THE MACHINE WAS FUNCTIONING AS EXPECTED WITHOUT PROBLEMS. UPON FOLLOW-UP WITH THE USER FACILITY,

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21494429 ↗
• MalfunctionJan 16, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY CHARGE NURSE REPORTED THAT A 5008X BLOODLINE BLOOD LEAK OCCURRED APPROXIMATELY TWENTY-FIVE MINUTES AFTER THE START OF A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE BLOOD LEAK ORIGINATED FROM THE CONNECTION AT THE BOTTOM OF THE VENOUS CHAMBER. IT WAS REPORTED THAT THE MACHINE, A 5008X HD MACHINE, TRIGGERED A BLOOD LEAK SENSOR ALARM. THERE WERE NO ISSUES DURING PRIME, AND THERE WERE NO OTHER KNOWN ISSUES LEADING UP TO THE LEAK. ADDITIONAL DETAILS WERE PROVIDED UPON FOLLOW-UP WITH THE NURSE. THE NURSE CONFIRMED BLOOD WAS SEEN LEAKING FROM THE CONNECTION AT THE BOTTOM OF THE VENOUS CHAMBER. ADDITIONALLY, THEY REPORTED THAT PHYSICAL DAMAGE WAS VISIBLE AT THE CONNECTION. THE PATIENT'S ESTIMATED BLOOD LOSS (EBL) DUE TO THE EVENT WAS 320 ML. THIS ESTIMATE INCLUDES BLOOD THAT LEAKED AS WELL AS WHAT REMAINED IN THE LINES AND COULD NOT BE RETURNED. IT WAS 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 A SHORTENED TREATMENT AFTER RESTARTING ON THE SAME MACHINE. A SAMPLE WAS REPORTEDLY RETURNED FOR MANUFACTURER EVALUATION. A FRESENIUS FIELD SERVICE TECHNI

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21169800 ↗
• MalfunctionJan 16, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY'S BIOMEDICAL TECHNICIAN (BMT) REPORTED THAT A 5008X HEMODIALYSIS (HD) MACHINE DISPLAYED A "BLOOD LEAK DETECTED" ALARM DURING A PATIENT'S HD TREATMENT. A FRESENIUS FIELD SERVICE TECHNICIAN (FST) WAS CALLED ONSITE AND VERIFIED THAT THE BLOOD LEAK DETECTOR WAS FUNCTIONING CORRECTLY. MACHINE FUNCTIONAL TESTS WERE COMPLETED AND PASSED ONSITE AFTER REPAIR. FOLLOW UP WITH THE CHARGE NURSE (CN) REVEALED THAT A FRESENIUS 5008X BLOODLINE LEAKED TWENTY-FIVE MINUTES INTO A PATIENT'S HD TREATMENT. THE MACHINE, A FRESENIUS 5008X HEMODIALYSIS (HD) MACHINE ALARMED APPROPRIATELY WITH A ¿BLOOD LEAK DETECTED" ALARM. BLOOD LEAK TEST STRIPS WERE NOT USED. A FRESENIUS DIALYZER WAS ALSO IN USE. THE LEAK WAS OBSERVED FROM THE CONNECTION AT THE BOTTOM OF THE VENOUS CHAMBER OF THE DIALYZER. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 320ML. 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. THE COMPLAINT DEVICE WAS REPORTED TO BE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21168355 ↗
• MalfunctionAug 2, 2024Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY CHARGE NURSE (CN) REPORTED THAT A FRESENIUS 5008X BLOODLINE RUPTURED AT THE ARTERIAL PRESSURE DOME DURING A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE CN STATED THERE WERE AIR DETECTED IN LINES ALARMS GOING OFF APPROXIMATELY ONE TO TWO HOURS INTO THE PATIENT'S TREATMENT, AND THEY COULD NOT FIGURE OUT WHAT WAS CAUSING IT. THE CN SAID THE ARTERIAL PRESSURE DOME IS HIDDEN FROM PLAIN VIEW, BUT THEY EVENTUALLY NOTICED BLOOD TRICKLING FROM BEHIND THE COMPONENT. THE PATIENT'S BLOOD WAS REINFUSED, AND THEY WERE RE-SETUP WITH NEW SUPPLIES ON THE SAME MACHINE. UPON CLOSER INSPECTION OF THE BLOODLINE, A TINY SLIT WAS OBSERVED ON THE ARTERIAL PRESSURE DOME. NO PHYSICAL DAMAGE WAS NOTED ON THE BLOODLINE PRIOR TO SET-UP, AND THERE WERE NO OTHER ISSUES OR ALARMS LEADING UP TO THE LEAK. THE CN ALSO CONFIRMED THERE WERE NO CHANGES IN THE PATIENT'S BLOOD FLOW RATE (BFR) PRIOR TO THE RUPTURE OCCURRING. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) DUE TO THE LEAK WAS 30 ML. THE CN 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 DID NOT COMPLETE THEIR FULL TREATMENT; THEY ASKE

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19899853 ↗