2008® Series Hemodialysis Machines 190713Recalls & reported problems

Summary

The FDA's MAUDE database contains 893 adverse event reports that list this exact device (DI 00840861100897), received between Aug 18, 2015 and Sep 4, 2026 — classified as 37 deaths, 75 injuries, 781 malfunctions.

The most frequently reported specific device problem is “Thermal Decomposition of Device” (379 reports).

3 FDA recall records name this device's identifier, 3 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. Aug 8, 2024Class IIOpen, Classified

   Machines equipped with BPM3 Blood Pressure Modules (Blood pressure monitor TM-2917B with firmware version S005) will not record Blood Pressure measurements and does not alarm if the cuff tubing is kinked close to the cuff.

   Z-3124-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. Sep 6, 2023Class IOpen, Classified

   Potential PCBA leaching from tubing of hemodialysis machines.

   Z-0028-2024 · Root cause: Device Design · Recall details · FDA record ↗

3. Jul 27, 2022Class IIOpen, Classified

   (1)Software version 2.74 upgrade and (2)hardware related cause that affects only CDX Machines, has been identified as the UI-MICs Board is sensitive to Electromagnetic Interference (EMI) which will cause the false alarm "Remove USB 2 Device".

   Z-0734-2023 · Root cause: Process design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 893 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 4, 2026Thermal Decomposition of Device

  A user facility's biomedical technician (BMT) reported that a 2008T Hemodialysis (HD) Machine "burnt out" the heating rod. A patient was not connected to the machine at the time of the incident and there was no harm to any patients or individuals because of this malfunction. 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 50614080 ↗
• DeathAug 21, 2026Adverse Event Without Identified Device or Use Problem

  Fresenius Medical Care was made aware of a hemodialysis (HD) patient who expired after being transported from the HD clinic to the hospital after experiencing cardiac arrest on (b)(6) 2026. This patient arrived for a regularly scheduled 4-hour HD treatment utilizing the 2008T machine on (b)(6) 2026. At 0551 the patient¿s pre-treatment vitals were recorded as follows: sitting blood pressure (BP) 165/80, standing BP 157/73, pule 67, respirations 19, temperature 96.2. The patient was found to be 95.5kg, a gain of 3.0kg. The treatment records also documented use of Oxygen via nasal cannula at 2L/min. The patient was administered a heparin loading dose of 5,000 units at 0553 at which time hemoglobin labs were drawn. At 0555 the patient lines were connected to the patient. At 0557 the patient grabbed his chest and stated he did not feel well. The patient turned blue, 911 was called, and chest compressions were started. At 0603 emergency medical services (EMS) arrived in the parking lot and at 0605 EMS took over care of the patient. The patient arrived at the hospital after 7-8 minutes of chest compressions prior to arrival and had achieved return of spontaneous circulation (ROSC). The pa

  Patient problems: Cardiac Arrest

  MAUDE report 50376512 ↗
• MalfunctionAug 14, 2026Thermal Decomposition of Device

  A user facility¿s' biomedical technician (BMT) reported to FME Technical Support a 2008T machine experienced a ¿Conductivity Confirmation Cell Calibration Error¿ Message. Upon follow up, the BMT said that during repair it was discovered that the power cord was burned and blackened. The BMT reported that there was no melting, burning smell, smoke, spark, flame, or arcing observed. The BMT reported that the machine has not had any past problems with failing the electrical leakage test and that there was no damage observed on any other components. The machine has approximately 39,000 hours and is plugged into a hospital grade ground-fault circuit interrupter (GFCI) outlet. The machine was returned to service after they replaced the power cord. A patient was not connected to the machine at the time of the incident and there was no harm to any patients or individuals because of this malfunction. The complaint device is not available to be returned to the manufacturer for evaluation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50256403 ↗
• MalfunctionJul 16, 2026Thermal Decomposition of Device

  A USER FACILITY'S BIOMEDICAL TECHNICIAN (BMT) REPORTED THAT A 2008T HEMODIALYSIS (HD) MACHINE HAD A MELTED FLOAT SWITCH ON THE HYDROCHAMBER. THEY BMT HAD RECENTLY REPLACED THE HYDROCHAMBER AND WHEN THE DEVICE WAS POWERED ON, WATER WAS SPRAYING FROM THE VENT TUBE. THE BMT REMOVED THE FLOAT SWITCH AND FOUND IT WAS MELTED PREVENTING THE FLOAT FROM MOVING FREELY. UPON FOLLOW UP, THE BMT SAID THAT THE ISSUE WAS NOTICED DURING MACHINE REPAIR. A PATIENT WAS NOT CONNECTED TO THE MACHINE AT THE TIME OF THE INCIDENT AND THERE WAS NO HARM TO ANY PATIENTS OR INDIVIDUALS BECAUSE OF THIS MALFUNCTION. THE HYDROCAHMBER WAS BRAND NEW AND THIS AS AN OUT-OF-BOX FAILURE. THE BMT REPORTED THAT THERE WAS NO BURNING SMELL, SMOKE, SPARK, FLAME, OR ARCING OBSERVED. THE BMT REPORTED THAT THE MACHINE HAS NOT HAD ANY PAST PROBLEMS WITH FAILING THE ELECTRICAL LEAKAGE TEST AND THAT THERE WAS NO DAMAGE OBSERVED ON ANY OTHER COMPONENTS. THE MACHINE HAS APPROXIMATELY 34,000 HOURS AND IS PLUGGED INTO A HOSPITAL GRADE GROUND-FAULT CIRCUIT INTERRUPTER (GFCI) OUTLET. THE BMT REPLACED THE HYDROCAHMBER, WHICH RESOLVED THE ISSUE. THE BMT REPORTED THAT THE MACHINE HAS BEEN RETURNED TO SERVICE WITHOUT ISSUE. THE HYDROCAHMB

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25840598 ↗
• MalfunctionJun 29, 2026Thermal Decomposition of Device

  A USER FACILITY'S BIOMEDICAL TECHNICIAN (BMT) REPORTED THAT A FRESENIUS 2008T HEMODIALYSIS (HD) MACHINE DISPLAYED AN ¿E.08 +24V IS OUTSIDE ALLOWABLE RANGE¿ ERROR MESSAGE DURING RINSE MODE. UPON FOLLOW UP, THE BMT SAID THAT THEY REPLACED THE LP955 BOARD, BUT THAT DID NOT RESOLVE THE ISSUE. THEY THEN FOUND A BURNT, BROWN WIRE ON THE BRIDGE RECTIFIER CONNECTION ON THE POWER SUPPLY. THE BMT SAID THAT THE POWER SUPPLY WAS THE ORIGINAL FRESENIUS PART ON THE MACHINE. THAT THERE WAS NO MELTING, BURNING SMELL, SMOKE, SPARK, FLAME, OR ARCING OBSERVED. THE BMT REPORTED THAT THE MACHINE HAS NOT HAD ANY PAST PROBLEMS WITH FAILING THE ELECTRICAL LEAKAGE TEST AND THAT THERE WAS NO DAMAGE OBSERVED TO ANY OTHER COMPONENTS. THE MACHINE HAS APPROXIMATELY 30,000 HOURS AND IS PLUGGED INTO A HOSPITAL GRADE GROUND-FAULT CIRCUIT INTERRUPTER (GFCI) OUTLET. THE BMT REPLACED THE POWER SUPPLY, WHICH RESOLVED THE ISSUE. THE BMT REPORTED THAT THE MACHINE HAS BEEN RETURNED TO SERVICE WITHOUT ISSUE. THE POWER SUPPLY IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. NO PHOTOS ARE AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25652964 ↗
• MalfunctionJun 2, 2026Smoking

  A BIOMEDICAL TECHNICIAN (BMT) REPORTED SMOKE ASSOCIATED WITH A 2008T MACHINE. THE BMT FOUND A DAMAGED VALVE. THERE WAS NO PATIENT INVOLVED. IN A FOLLOW UP, THE BMT SAID WHEN THE EVENT HAPPENED THE MACHINE WAS IN THE BACK AND WAS NOT BEING USED. NO ALARMS WENT OFF. THE STAFF CLAIMED THERE WAS SMOKE, BUT BMT DID NOT OBSERVE IT. THE BMT REMOVED VALVE 33 AND REPLACED IT WITH A BRAND NEW ONE. A WIRE ISSUE CAUSED THE SOLENOID TO OVERHEAT AND BEGIN TO SWELL. THERE WAS NO OTHER DAMAGE TO THE MACHINE OR WALL OUTLET. AN ELECTRICAL LEAKAGE TEST WAS PERFORMED AFTERWARDS AND NOTHING WAS OUT OF RANGE. THERE ARE NO SAMPLES AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25367727 ↗
• MalfunctionMay 6, 2026Thermal Decomposition of Device; Fire; Fluid/Blood Leak; Smoking

  A user facility Biomedical Technician (BMT) reported the 2008T power supply caught fire and started smoking during dialysis (treatment) mode. The BMT stated the display went blank and the device started audibly alarming as they saw smoke coming from the power supply. The nurse stated the patient was removed immediately and placed on another device to complete treatment. There were fire and flames seen coming from the power switch area on the power supply. The BMT stated they used a fire extinguisher to put out the fire. The BMT stated the patient lost about 100 cc's of blood as they could not rinse back. Upon additional information received, the BMT stated when the incident occurred there was smoke, and a small visible fire seen through the fan vent. The machine was plugged into a hospital grade GFCI (ground-fault circuit interrupter) outlet and had not failed an electrical leakage test. The machine has not been returned to service as the BMT was still cleaning the debris from the fire extinguisher, performing checks on each module, and had to replace the power supply. The BMT reported other components may need to be replaced but have not been identified. The BMT reported the botto

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25094711 ↗
• MalfunctionApr 24, 2026Inadequate Ultra Filtration

  A USER FACILITY'S BIOMEDICAL TECHNICIAN (BMT) REPORTED THAT A 5008X HEMODIALYSIS (HD) MACHINE¿S ULTRAFILTRATION (UF) DID NOT ENGAGE DURING A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE PATIENT SUCCESSFULLY COMPLETED TREATMENT WITH NO PATIENT SERIOUS INJURY OR MEDICAL INTERVENTION REQUIRED. THE PATIENT SUFFERED A PANIC ATTACK WHEN THEY REACHED THE WAITING ROOM TO LEAVE. AN AMBULANCE WAS CALLED. IT IS UNKNOWN IF THE MACHINE HAS BEEN RETURNED TO SERVICE. IT IS UNKNOWN IF THE COMPLAINT DEVICE IS AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24982475 ↗
• MalfunctionApr 16, 2026Smoking

  A BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS TECHNICAL SUPPORT (TS) THAT A 2008T HEMODIALYSIS MACHINE WAS EXPERIENCING AN ISSUE WHERE IT WOULD NOT POWER ON. THE MOTHERBOARD WAS REPLACED AND THE MACHINE WAS ABLE TO BE POWERED ON. HOWEVER, THE BIOMED NOTICED A BURNING SMELL COMING FROM THE CARD CAGE. THE BIOMED COULD NOT DISCERN WHICH BOARD WAS PRODUCING THE BURNING SMELL. THE POWER LOGIC BOARD WAS REPLACED NEXT, AND WHEN THE MACHINE WAS POWERED ON SMOKE WAS SEEN COMING FROM THE POWER CONTROL BOARD. THE POWER SUPPLY ASSEMBLY WAS REPLACED AFTER THIS, AND THE MACHINE STARTED GIVING A HEATER RELAY ERROR. AFTER CHECKING THE TROUBLESHOOTING GUIDE, IT WAS DETERMINED THAT THE POWER LOGIC BOARD AND THE POWER CONTROL BOARD HAD TO BE REPLACED AT THE SAME TIME. REPLACING THESE PARTS TOGETHER RESOLVED THE REPORTED ISSUE. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION, AND THUS FAR NO FURTHER DETAILS HAVE BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24903478 ↗
• MalfunctionApr 15, 2026Fluid/Blood Leak

  A USER FACILITY'S BIOMEDICAL TECHNICIAN (BMT) REPORTED THAT A 2008T HEMODIALYSIS (HD) MACHINE'S BLOOD PUMP ROTOR CUT THE BLOOD PUMP TUBING SEGMENT DURING A PATIENT'S HD TREATMENT RESULTING IN BLOOD LOSS. THE PATIENT'S ESTIMATED BLOOD LOSS (EBL) IS 230ML. IT IS UNKNOWN IF THERE WAS ANY PATIENT SERIOUS INJURY OR ADVERSE EVENT.UPON FOLLOW UP, THE BMT SAID THAT THE MACHINE ALARMED APPROPRIATELY WITH AN AIR DETECTOR ALARM. A FRESENIUS DIALYZER AND BLOODLINE WERE BOTH IN USE. THE MACHINE WAS RETURNED TO SERVICE AFTER HE REPLACED THE BLOOD PUMP ROTOR. THE COMPLAINT DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24886995 ↗
• MalfunctionApr 15, 2026Inadequate Ultra Filtration

  A USER FACILITY'S BIOMEDICAL TECHNICIAN (BMT) REPORTED THAT A 2008T HEMODIALYSIS (HD) MACHINE REMOVED TOO MUCH ULTRAFILTRATION (UF) DURING A PATIENT'S HD TREATMENT. THE PATIENT COMPLETED TREATMENT ON THE DEVICE WITHOUT ANY SERIOUS INJURY OR MEDICAL INTERVENTION REQUIRED. UPON FOLLOW UP, THE BMT SAID THAT THE MACHINE WAS DETERMINED TO BE WORKING PROPERLY. THE MACHINE WAS RETURNED TO SERVICE WITHOUT ANY REPAIRS OR ADJUSTMENTS. THE MACHINE HAS NOT EXPERIENCED ANY ISSUES SINCE BEING RETURNED TO SERVICE. NO SAMPLE IS AVAILABLE.MULTIPLE ATTEMPTS HAVE BEEN MADE TO CONTACT THE CLINICIAN 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 24886069 ↗
• MalfunctionApr 6, 2026Fire

  A USER FACILITY'S BIOMEDICAL TECHNICIAN (BMT) REPORTED THAT A 2008T HEMODIALYSIS (HD) MACHINE EXPERIENCED A FIRE DURING A PATIENT'S HD TREATMENT. UPON FOLLOW UP, THE BMT SAID THAT THE FIRE ORIGINATED IN THE POWER SUPPLY. THE CAUSE OF THE FIRE WAS UNKNOWN; HOWEVER, THERE WAS A BURNING SMELL AS WELL AS VISIBLE SMOKE AND FLAMES. THE BMT CONFIRMED THAT THE MACHINE HAS APPROXIMATELY 29,953 HOURS AND IS PLUGGED INTO A HOSPITAL GRADE GROUND-FAULT CIRCUIT INTERRUPTER (GFCI) OUTLET. THE MACHINE HAS NOT HAD ANY PAST PROBLEMS WITH FAILING THE ELECTRICAL LEAKAGE TEST. THE POWER SUPPLY WAS THE ORIGINAL FRESENIUS PART ON THE MACHINE. THERE WAS NO DAMAGE TO ANY OTHER COMPONENTS DUE TO THE EVENT. THERE WAS NO HARM TO ANY PATIENTS OR INDIVIDUALS BECAUSE OF THIS EVENT. THE PATIENT WAS RESTARTED ON A NEW MACHINE AND TREATMENT COMPLETED SUCCESSFULLY WITH NEW SUPPLIES. THERE WAS NO PATIENT SERIOUS INJURY OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THIS EVENT. THE PATIENT¿S BLOOD WAS NOT RETURNED FOLLOWING THE EVENT. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) IS UNKNOWN. A FRESENIUS FIELD SERVICE TECHNICIAN (FST) WAS CALLED ONSITE AND THEY REPLACED THE POWER SUPPLY TO RESOLVE THE ISSUE. NO OTHER ISSUE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24789390 ↗
• MalfunctionMar 11, 2026Fluid/Blood Leak

  A USER FACILITY'S BIOMEDICAL TECHNICIAN (BMT) REPORTED THAT A 2008T HEMODIALYSIS (HD) MACHINE'S BLOOD PUMP ROTOR CUT THE BLOOD PUMP TUBING SEGMENT DURING A PATIENT'S HD TREATMENT RESULTING IN BLOOD LOSS. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) IS 250ML. IT WAS REPORTED AT INTAKE THAT THERE WAS NO PATIENT SERIOUS INJURY OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THIS EVENT. THE BMT SAID THAT THE MACHINE WAS RETURNED TO SERVICE AFTER HE REPLACED THE BLOOD PUMP MODULE. THE COMPLAINT DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24568850 ↗
• MalfunctionFeb 17, 2026Thermal Decomposition of Device

  A user facility Biomedical Technician (BMT) reported they were working on a 2008T hemodialysis (HD) machine that had damage to the distribution board and heater rod wiring. One of the wires for the heater rod arced. The BMT replaced the distribution board and heater rod. The BMT stated they were having to set the Digital-to-Analog Converter (DAC) value up to 160-165 to achieve 37 degrees Celsius and asked if this was normal. The BMT was advised the DAV value range was 0-255. Upon follow-up, the BMT stated during troubleshooting of calibrating DAC values it was discovered the distribution board and heater rod wiring appeared arced and burnt. The BMT replaced the distribution board and heater rod wiring and this resolved the issue. No smoke or melting was noted, and there were no reports of sparks or flames. The machine was plugged into a hospital grade ground-fault circuit interrupter (GFCI) outlet, and there was no previous history of the machine failing the electrical leakage test. The BMT stated the machine was repaired but has not yet been returned to service. The replaced parts were no longer available to be returned for evaluation. There was no patient involvement associated w

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24365209 ↗
• MalfunctionFeb 9, 2026Fluid/Blood Leak; Material Split, Cut or Torn

  IT WAS REPORTED THAT A 2008T HEMODIALYSIS (HD) MACHINE'S BLOOD PUMP ROTOR SLICED THE BLOOD PUMP TUBING TWO HOURS INTO A PATIENT'S HD TREATMENT. IT WAS NOTED THAT BLOOD WAS DRIPPING FROM THE BLOOD PUMP TUBING. THE BLOOD PUMP STOPPED AND IT WAS FOUND THAT THE BLOOD PUMP HAD SLICED APPROXIMATELY A HALF INCH ON THE FRONT SURFACE OF THE TUBING. UPON FOLLOW UP, IT WAS CONFIRMED THAT THE MACHINE ALARMED WITH AN ¿AIR IN BLOOD¿ ALARM. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS 300 ML. IT WAS CONFIRMED THAT THE PATIENT REQUIRED ONE UNIT OF PACKED RED BLOOD CELLS (PRBC). THE PATIENT WAS RESTARTED ON A NEW MACHINE AND TREATMENT COMPLETED SUCCESSFULLY WITH NEW SUPPLIES. THE BLOOD LINES WERE DISCARDED. THE BLOOD PUMP WAS INSPECTED, DEEMED IT ACCEPTABLE TO RETURN TO SERVICE AND IS IN ANOTHER MACHINE. A NEW BLOOD PUMP WAS PUT IN THE MACHINE. THE MACHINE IS BACK IN SERVICE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24297412 ↗
• MalfunctionFeb 2, 2026Thermal Decomposition of Device; Arcing; Sparking

  A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED THAT A FRESENIUS 2008T HEMODIALYSIS (HD) MACHINE PRODUCED AN ELECTRIC ARC WHICH CAME FROM THE POWER SUPPLY. THE BIOMED SAID THE MACHINE WAS INITIALLY PULLED FROM THE TREATMENT FLOOR FOR FAILING AN UNKNOWN TEST DURING SET-UP. THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE EVENT. WHEN THE MACHINE WAS TURNED ON FOR TESTING, A SPARK (OR ARC) WAS OBSERVED COMING FROM THE POWER SUPPLY. THE MACHINE WAS IMMEDIATELY TURNED OFF AND UNPLUGGED. UPON FURTHER INSPECTION, A BURNT WIRE WAS IDENTIFIED ON THE BACK OF THE POWER SUPPLY BOARD. THE BIOMED SAID THE WIRE LOOKED SCORCHED OR BLACKENED. A BURNT ELECTRICAL SMELL WAS ALSO REPORTED TO BE PRESENT. NO OTHER COMPONENTS WERE FOUND TO BE DAMAGED. IT IS BELIEVED THAT THE POWER SUPPLY WAS THE ORIGINAL FRESENIUS PART THAT CAME WITH THE SYSTEM. THE BIOMED REPLACED THE POWER SUPPLY UNIT AND THIS REPORTEDLY RESOLVED THE ISSUE. THE MACHINE SUBSEQUENTLY PASSED TESTING AND WAS RETURNED TO SERVICE. THE BIOMED STATED THE MACHINE HAD 45,384 OPERATING HOURS ON IT. IT WAS CONFIRMED THE MACHINE WAS PLUGGED INTO A HOSPITAL GRADE GROUND-FAULT CIRCUIT INTERRUPTER (GFCI) OUTLET AND HAD NO PREVIOUS HISTORY O

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24242559 ↗
• MalfunctionJan 15, 2026Fluid/Blood Leak

  A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS TECHNICAL SUPPORT THAT A 2008T MACHINE¿S BLOOD PUMP ROTOR CUT THE BLOOD TUBING DURING A PATIENT¿S HEMODIALYSIS (HD) TREATMENT WHICH RESULTED IN BLOOD LOSS. ADDITIONAL DETAILS WERE PROVIDED UPON FOLLOW-UP WITH THE BIOMED. THE MACHINE ALARMED WITH AN AIR DETECTED MESSAGE AND BLOOD WAS OBSERVED LEAKING FROM THE BLOOD PUMP. THE BIOMED WAS UNSURE HOW LONG INTO THE TREATMENT THIS OCCURRED. THERE WERE NO UNUSUAL NOISES COMING FROM THE BLOOD PUMP. UPON INSPECTION OF THE SETUP, IT WAS NOTED THAT BLOOD WAS LEAKING FROM THE TUBING WITHIN THE BLOOD PUMP. THE BIOMED SAID THE CAP ON ONE OF THE BLOOD PUMP ROTOR GUIDES CAME LOOSE AND DAMAGED THE TUBING. WHEN THE NIPRO BLOODLINE WAS REMOVED FROM THE BLOOD PUMP ROTOR, A VISIBLE CUT WAS OBSERVED ON THE BLOOD PUMP TUBING SEGMENT. THE BLOODLINE WAS INSPECTED FOR DAMAGE PRIOR TO TREATMENT INITIATION, AND THERE WERE NO APPARENT DEFECTS NOTED AT THAT TIME. ONCE THE LEAK WAS NOTICED, THE DIALYSIS TREATMENT WAS STOPPED. THE PATIENT¿S BLOOD WAS NOT RETURNED. ESTIMATED BLOOD LOSS (EBL) DUE TO THE EVENT WAS ABOUT 200 ML. THE MACHINE WAS REMOVED FROM SERVICE FOR EVALUATION. THE BIOMED SAID THE

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24086168 ↗
• MalfunctionNov 28, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY CHARGE NURSE (CN) REPORTED THAT A BLOOD LEAK OCCURRED DURING A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. ADDITIONAL DETAILS WERE PROVIDED THROUGH FOLLOW-UP WITH THE CN. THE BLOOD LEAK WAS REPORTEDLY CAUSED BY THE FRESENIUS 2008T MACHINE, AS THE BLOOD PUMP ROTOR DAMAGED THE BLOOD PUMP SEGMENT OF THE COMBI SET TUBING. THE INCIDENT OCCURRED APPROXIMATELY SIXTY TO NINETY MINUTES INTO THE TREATMENT. THERE WAS AN UNSPECIFIED ALARM FROM THE MACHINE, AND WHEN THE TECHNICIAN WENT TO ADDRESS THE ALARM, THEY NOTICED BLOOD DRIPPING FROM THE BLOOD PUMP. THE CN SAID THE BLOODLINE WAS INSPECTED PRIOR TO USE, AND NO DAMAGE WAS NOTED ON THE TUBING AT THAT TIME. THERE WERE NO UNUSUAL NOISES COMING FROM THE BLOOD PUMP ROTOR DURING TREATMENT AND/OR DURING THE PRIME. THE DECISION WAS MADE NOT TO RETURN THE PATIENT'S BLOOD, WHICH RESULTED IN APPROXIMATELY 250 ML OF BLOOD LOSS. 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 A DIFFERENT MACHINE. THE MACHINE WAS REMOVED FROM SERVICE FOR EVALUATION, AND THE BLOOD P

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23675463 ↗
• MalfunctionOct 24, 2025Thermal Decomposition of Device; Thermal Decomposition of Device

  THE BIOMEDICAL TECHNICIAN (BIOMED) FOR A USER FACILITY REPORTED TO FRESENIUS TECHNICAL SERVICES THAT THERMAL DECOMPOSITION WAS IDENTIFIED WITHIN THE 2008T MACHINE. THE REPORTED ISSUE WAS DISCOVERED UPON MACHINE EVALUATION FOR AN INTERMITTENT 24V HIGH ERROR. THE BRIDGE RECTIFIER, THE TWO WHITE WIRES CONNECTED TO THE TRANSFORMER, AND THE POWER CORD WERE BURNED. A REPLACEMENT POWER SUPPLY WAS ORDERED AND INSTALLED. A CONDUCTIVITY OFFSET FAILURE ALARM WAS THEN RECEIVED. FURTHER EVALUATION WAS PERFORMED AND THE CAUSE WAS DETERMINED TO BE THE SENSOR BOARD. A REPLACEMENT SENSOR BOARD WAS ORDERED TO RESOLVE THIS ISSUE. AT THE TIME OF FOLLOW-UP, THE MACHINE REMAINED OUT OF SERVICE PENDING REPAIR. A BURNING SMELL WAS OBSERVED HOWEVER THERE WAS NO SMOKE, SPARK, FLAME, OR ARCING. THE MACHINE HAS APPROXIMATELY 30,000 OPERATING HOURS AND THE PARTS ARE ORIGINAL TO THE MACHINE. THE MACHINE IS PLUGGED INTO A 20-AMP HOSPITAL-GRADE GROUND-FAULT CIRCUIT INTERRUPTER (GFCI) OUTLET. THERE WAS NO HARM TO ANY PATIENTS OR INDIVIDUALS AS A RESULT OF THIS MALFUNCTION. NO PARTS WILL BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23379802 ↗
• InjuryOct 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 2/OCT/2025, FRESENIUS BECAME AWARE THIS UNKNOWN PATIENT WITH RENAL FAILURE (RF) ON HEMODIALYSIS (HD) UTILIZING A 2008T HEMODIALYSIS SYSTEM FOR RENAL REPLACEMENT THERAPY (RRT) ¿CODED¿ (CARDIAC ARREST) WHILE UNDERGOING HD THERAPY. THE USER FACILITY CONTACTED FRESENIUS CUSTOMER SUPPORT TO REQUEST AND EVALUATION OF THE DEVICE. ON (B)(6) 2025, A FRESENIUS FIELD SERVICE TECHNICIAN (FST) WAS DISPATCHED TO PERFORM POST-EVENT FUNCTIONAL COMPLIANCE AND ULTRAFILTRATION (UF) TESTING ON THE 2008T HEMODIALYSIS SYSTEM. ALL POST-EVENT TESTING WAS COMPLETED AND PASSED WITHOUT ISSUE. THERE WERE NO VALUES OUT-OF-RANGE, NOR WERE THERE ANY ERRORS NOTED WHILE PERFORMING A SIMULATED TREATMENT. SUBSEQUENT ATTEMPTS TO OBTAIN ADDITIONAL CLINICAL INFORMATION (E.G., PATIENT DEMOGRAPHICS, OUTCOME OF CODE EVENT(S), PAST MEDICAL HISTORY, HOSPITAL COURSE) WERE UNSUCCESSFUL.

  Patient problems: Cardiac Arrest

  MAUDE report 23349498 ↗
• DeathOct 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A USER FACILITY REPORTED TO FRESENIUS THAT A HEMODIALYSIS (HD) PATIENT CODED DURING HD THERAPY ON A 2008T HEMODIALYSIS SYSTEM. ADDITIONAL DETAILS WERE OBTAINED THROUGH FOLLOW-UP WITH THE FACILITY¿S INPATIENT PROGRAM MANAGER (IPM). THE IPM CONFIRMED A PATIENT SUFFERED A CARDIAC ARREST DURING HD THERAPY ON (B)(6) 2025. THE IPM STATED THE PATIENT WAS IN THE INTENSIVE CARE UNIT (ICU) SUFFERING FROM MULTISYSTEM ORGAN FAILURE AND WAS UNLIKELY TO SURVIVE REGARDLESS OF HD THERAPY. HD THERAPY WAS ONLY ATTEMPTED AS A FINAL EFFORT AT STABILIZING THE PATIENT. ONCE THE CARDIAC ARREST OCCURRED, THE PATIENT WAS DISCONNECTED FROM THE 2008T HEMODIALYSIS SYSTEM AND ADVANCED CARDIAC LIFE SUPPORT (ACLS) MEASURES WERE UNDERTAKEN, HOWEVER THE PATIENT WAS UNABLE TO BE REVIVED. THE IPM STATED EVERY CODE SITUATION IS EVALUATED BY THE NEPHROLOGIST AND THE HOSPITAL¿S RISK MANAGEMENT DEPARTMENT TO DETERMINE IF THE DIALYSIS EQUIPMENT INVOLVED WAS A CAUSAL OR CONTRIBUTING FACTOR. IN THIS CASE THE IPM STATED THERE WAS NO FAULT FOUND WITH ANY FRESENIUS DEVICE(S) AND/OR PRODUCT(S). THE IPM ALSO REPORTED THAT THE 2008T HEMODIALYSIS SYSTEM WAS SEQUESTERED FOLLOWING THE EVENTS AND PASSED ALL POST-EVENT FUNCTIONAL COM

  Patient problems: Cardiac Arrest

  MAUDE report 23196773 ↗
• MalfunctionSep 26, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS TECHNICAL SUPPORT THAT BLOOD PUMP ROTOR FROM A 2008T HEMODIALYSIS (HD) MACHINE DAMAGED THE BLOOD PUMP TUBING SEGMENT OF A BLOODLINE DURING A PATIENT¿S HD TREATMENT. ADDITIONAL DETAILS WERE OBTAINED UPON FOLLOW-UP WITH THE BIOMED AND A PATIENT CARE TECHNICIAN (PCT) FAMILIAR WITH THE EVENT. WITH APPROXIMATELY THIRTY MINUTES REMAINING IN THE TREATMENT, THE 2008T MACHINE BEGAN ALARMING WITH AN AIR DETECTOR MESSAGE. THE PCT RESET THE ALARM, AND SHORTLY AFTERWARDS IT WENT OFF AGAIN. THE PCT THEN HEARD A GRINDING NOISE COMING FROM THE BLOOD PUMP, AND THEY NOTICED BLOOD LEAKING FROM THE TUBING WITHIN THE BLOOD PUMP. IT WAS DETERMINED THAT THE BLOOD PUMP ROTOR DAMAGED THE TUBING WHICH CAUSED THE LEAK. WHEN THE BLOODLINE WAS REMOVED FROM THE BLOOD PUMP ROTOR, A VISIBLE PUNCTURE MARK WAS NOTED ON THE BLOOD PUMP TUBING SEGMENT. THE BLOODLINE WAS INSPECTED FOR DAMAGE PRIOR TO TREATMENT INITIATION, AND THERE WERE NO APPARENT DEFECTS NOTED AT THAT TIME. ONCE THE PCT NOTICED THE LEAK, THE DIALYSIS TREATMENT WAS STOPPED. BLOOD WAS RETURNED FROM BOTH THE ARTERIAL AND VENOUS SIDES OF THE CIRCUIT. THE ARTERIAL SIDE HAD TO BE RETURNED

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23161886 ↗
• MalfunctionSep 25, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY CLINICAL MANAGER (CM) REPORTED THAT A DIALYZER BLOOD LEAK OCCURRED DURING A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE BLOOD LEAK OCCURRED TOWARDS THE END OF THE TREATMENT. THE BLOOD LEAK WAS INTERNAL, AND IT WAS CONFIRMED TO BE VISUALLY OBSERVED. LEADING UP TO THE EVENT, THE 2008T MACHINE WAS ALARMING NONSTOP WITH ELEVATED VENOUS PRESSURE AND TRANSMEMBRANE PRESSURE (TMP) ALARMS. HOWEVER, THE MACHINE DID NOT GIVE A BLOOD LEAK ALARM. A BLOOD LEAK TEST STRIP WAS NOT USED, AS IT WAS DEEMED UNNECESSARY. THERE WAS NO PHYSICAL DAMAGE OR DEFECT NOTED ON THE DIALYZER. FRESENIUS BLOODLINES WERE ALSO BEING USED FOR THE TREATMENT. AFTER THE LEAK WAS NOTED, THE BLOOD PUMP WAS STOPPED. IT WAS DOCUMENTED IN THE PATIENT SAFETY EVENT REPORT THAT THEY ATTEMPTED TO RETURN THE PATIENT¿S BLOOD AND WERE UNSUCCESSFUL. THE PATIENT¿S BLOOD WAS NOT RETURNED; ESTIMATED BLOOD LOSS (EBL) WAS 300 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 UNDERGO ANY ADDITIONAL TREATMENT. THE MACHINE WAS NOT REMOVED FROM SERVICE FOR EVALUATION. THE CM SAID THEY CONT

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23149706 ↗
• MalfunctionSep 19, 2025Thermal Decomposition of Device; Thermal Decomposition of Device

  A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED FINDING THERMAL DAMAGE ON THE FUNCTIONAL BOARD OF A FRESENIUS 2008T MACHINE. THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT. THE BIOMED SAID THE MACHINE POWERED OFF AS THE STAFF BEGAN SETTING UP THE MACHINES FOR THE DAY. THE MACHINE WAS REMOVED FROM SERVICE FOR EVALUATION. THE BIOMED INITIALLY THOUGHT THERE WAS AN ISSUE WITH THE POWER SUPPLY, AND THEY ATTEMPTED TO RESOLVE THE ISSUE BY REPLACING THE POWER LOGIC BOARD. AFTER DOING SO, THEY WERE ABLE TO POWER UP THE MACHINE. HOWEVER, THE CLIC DEVICE WAS NOT VERIFYING IN DIALYSIS MODE. IN ADDITION, THE KEYBOARD KEYS WERE NOT WORKING. UPON FURTHER INVESTIGATION THE BIOMED FOUND A BURNT SPOT ON THE FUNCTIONAL BOARD. THE BIOMED CONFIRMED THAT NO ADDITIONAL PARTS OR COMPONENTS WERE DAMAGED. IT WAS CONFIRMED THAT THE FUNCTIONAL BOARD WAS THE ORIGINAL FRESENIUS PART ON THE MACHINE. THERE WAS NO BURNING SMELL NOTICED. ADDITIONALLY, THERE WERE NO SIGNS OF ANY SMOKE, SPARKS, OR FLAMES. THERE WERE 15,620 OPERATING HOURS ON THE MACHINE. THE BIOMED CONFIRMED MACHINE WAS PLUGGED INTO A HOSPITAL GRADE GROUND-FAULT CIRCUIT INTERRUPTER (GFCI) OUTLET AND HAD NO PREVIOUS HISTOR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23103106 ↗
• MalfunctionSep 19, 2025Thermal Decomposition of Device; Thermal Decomposition of Device

  A USER FACILITY'S BIOMEDICAL TECHNICIAN (BMT) REPORTED THAT A 2008T HEMODIALYSIS (HD) MACHINE EMITTED A BURNING SMELL FROM THE POWER SUPPLY. A FRESENIUS FIELD SERVICE TECHNICIAN (FST) WAS CALLED ONSITE AND FOUND THAT THE 20-PIN CABLE THAT CONNECTS TO THE POWER LOGIC BOARD WAS BURNED. UPON FOLLOW UP, THE BMT SAID THAT THE 20-PIN CABLE WAS BLACKENED AND CHARRED. THERE WAS NO MELTING, SMOKE, SPARKS FLAMES OR ARCING. A PATIENT WAS NOT CONNECTED TO THE MACHINE AT THE TIME OF THE INCIDENT AND THERE WAS NO HARM TO ANY PATIENTS OR INDIVIDUALS BECAUSE OF THIS MALFUNCTION. THE MACHINE HAS 8,000 HOURS AND THE 20-PIN CABLE WAS THE ORIGINAL FRESENIUS PART ON THE MACHINE. THE BMT REPORTED THAT THERE WAS NO DAMAGE OBSERVED ON ANY OTHER COMPONENTS, OR ANY OTHER ADDITIONAL ISSUES, ASSOCIATED WITH THE BURNED AND CHARRED 20-PIN CABLE. THE FST REPLACED THE CABLE TO RESOLVE THE ISSUE. MACHINE FUNCTIONAL TESTS WERE COMPLETED AND PASSED ONSITE AFTER REPAIR. THE BMT CONFIRMED THAT THE UNIT WAS RETURNED TO SERVICE AT THE USER FACILITY WITHOUT ISSUE AND WITHOUT RECURRENCE OF THE EVENT. THE SAMPLE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23097713 ↗