2008® Series Hemodialysis Machines 190766Recalls & reported problems

Summary

The FDA's MAUDE database contains 370 adverse event reports that list this exact device (DI 00840861100910), received between Jul 6, 2017 and Sep 23, 2026 — classified as 15 deaths, 21 injuries, 334 malfunctions.

The most frequently reported specific device problem is “Thermal Decomposition of Device” (231 reports).

4 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-0030-2024 · 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 ↗

4. Oct 5, 2017Class IITerminated

   While reviewing documentation for the next software release of the 2008T, an R&D technician identified that setting the UF goal to '0' introduces a discrepancy between the UF rate displayed and the actual UF pump rate. The software anomaly is also applicable to the 2008T Machines that contained the 2.63 Bug Fix per DCAF 17-088. 2008T Upgrade kits that contained the 2.63 Bug Fix are also affected. Additionally, SW version 2.64 (in design freeze) is also impacted by this anomaly.

   Z-0829-2018 · Root cause: Software Design Change · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 370 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Fluid/Blood Leak

  A user facility¿s registered nurse (RN) reported that a FME 2008T hemodialysis (HD) machine leaked from the blood pump segment two hours and fifty minutes after the initiation of a patient¿s hemodialysis (HD) treatment. The machine, a FME 2008T machine, alarmed appropriately with an air detector alarm. A FME dialyzer was in use. The blood pump segment of the bloodline had a slit in it. The patient¿s estimated blood loss (EBL) was approximately 5mL. The patient was not restarted because they only had ten minutes left in their treatment. The machine was removed from service following the incident. The biomedical technician (BMT) was not able to find any issues with the blood pump; however, he did replace the blood pump and clip as a precaution because this is the second incident of this nature on this machine. 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: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50868087 ↗
• MalfunctionAug 11, 2026Thermal Decomposition of Device

  A user facility Biomedical Technician (BMT) reported to Technical Support a 2008T machine powers down on its own randomly. There was no patient involvement. The BMT swapped the power switch, keypad assembly and the power logic board. The BMT was advised to swap the power supply (to isolate), possible power control board issue, functional board, check the motherboard for any issues, check all cables for problems. Upon follow-up, the BMT stated they were still troubleshooting the reported issue, and the machine was still out of service. The BMT mentioned that the power switch was burned, so it was replaced. It was confirmed there was no patient involvement, harm, or adverse events associated with the reported issue. Additional information was requested but was not received to date.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50203347 ↗
• MalfunctionAug 11, 2026Thermal Decomposition of Device

  A user facility biomedical technician (biomed) reported to Fresenius technical support (TS) that a 2008T Hemodialysis machine was experiencing an issue with its display screen. The biomed stated the screen was black. The biomed said they had already replaced the UI mics board, the UI to function board ribbon cable, and the screen. TS advised the biomed to check the motherboard and all wired connections and connectors. Additional details were provided during follow-up with the biomed. Upon further investigation, the biomed identified thermal damage on the connector of the ground wire that goes from the power module to the main distribution board. The biomed replaced the whole power module (which included a new ground wire and connector), and this resolved the reported screen issue. No other components were found to be damaged. The distribution board did not have to be replaced. The biomed did not have any photos of the charred wire/connector. There was no burning smell noted, and there were no signs of any smoke, sparks, or flames. The biomed said the machine had 43,487 operating hours on it at the time of the event. The machine did not have any past problems failing the electrical

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50202782 ↗
• MalfunctionJul 17, 2026Fluid/Blood Leak

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25860716 ↗
• MalfunctionJul 10, 2026Thermal Decomposition of Device

  A Fresenius Field Service Technician (FST) was called onsite to repair a 2008T hemodialysis (HD) machine with a burning smell. The cause was fluid dripped into the card cage and damage the bridge rectifier, causing the power supply to burn the wire and bridge rectifier. After replacing with the new power supply the HD machine power on and off without any issues. The HD machine completed repair as of 06/26/26. After replacing with the new power supply the HD machine was placed into dialysis treatment functional check/ test which passes 6x and completed repair with a vinegar/ heat as of 06/26/2026. There was no patient involvement or injury noted at intake. Additional information was requested but was not received to date.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25780476 ↗
• MalfunctionJun 22, 2026Fluid/Blood Leak

  A BIOMEDICAL TECHNICIAN (BMT) REPORTED THAT THE VENOUS CHAMBER KEPT FILLING WITH BLOOD DURING DIALYSIS TREATMENT (TX) MODE. THERE WERE NO ADVERSE REACTIONS WITH THE PATIENT. THE PATIENT WAS ABLE TO COMPLETE TREATMENT ON THE DEVICE SINCE THE NURSE KEPT REPLACING THE EXTERNAL TRANSDUCER ON THE VENOUS PORT. THE BMT SWAPPED THE LEVEL DETECTOR MODULE AND THE PROBLEM DID NOT RESOLVE. TECHNICAL SUPPORT ADVISED THE BMT TO RE-CALIBRATE VENOUS/DIALYSATE PRESSURES AND CHECK THE TUBING CONNECTION AT THE LEVEL DETECTOR PRESSURE PORT TO VERIFY THE TUBING IS CORRECTLY INSTALLED. NEXT, THE BMT WAS ADVISED TO SWAP THE SENSOR, FUNCTIONAL OR MOTHERBOARDS TO RESOLVE THE ISSUE. UPON FOLLOW UP, THE BMT STATED THAT THE MOTHER BOARD WAS REPLACED TO RESOLVE THE ISSUE AND THE MACHINE HAS BEEN RETURNED TO SERVICE. THERE WERE NO INJURIES, ADVERSE EVENTS, OR MEDICAL INTERVENTION REQUIRED TO THE PATIENT OR USER. THE BMT COULD NOT CONFIRM IF THE MOTHER BOARD WAS AVAILABLE TO BE RETURNED FOR ANALYSIS. UPON FURTHER FOLLOW UP, THE TECHNICIAN REPORTED THAT 30 MINUTES INTO TREATMENT THE TRANSDUCER WAS GETTING SOAKED WITH BLOOD RESULTING IN AN UNKNOWN AMOUNT OF BLOOD LOSS ON 6/1/2026. NO BLOOD WAS RETURNED TO THE PATI

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25587530 ↗
• MalfunctionJun 22, 2026Fluid/Blood Leak

  A BIOMEDICAL TECHNICIAN (BMT) REPORTED THAT THE VENOUS CHAMBER KEPT FILLING WITH BLOOD DURING DIALYSIS TREATMENT (TX) MODE. THERE WERE NO ADVERSE REACTIONS WITH THE PATIENT. THE PATIENT WAS ABLE TO COMPLETE TREATMENT ON THE DEVICE SINCE THE NURSE KEPT REPLACING THE EXTERNAL TRANSDUCER ON THE VENOUS PORT. THE BMT SWAPPED THE LEVEL DETECTOR MODULE AND THE PROBLEM DID NOT RESOLVE. TECHNICAL SUPPORT ADVISED THE BMT TO RE-CALIBRATE VENOUS/DIALYSATE PRESSURES AND CHECK THE TUBING CONNECTION AT THE LEVEL DETECTOR PRESSURE PORT TO VERIFY THE TUBING IS CORRECTLY INSTALLED. NEXT, THE BMT WAS ADVISED TO SWAP THE SENSOR, FUNCTIONAL OR MOTHERBOARDS TO RESOLVE THE ISSUE. UPON FOLLOW UP, THE BMT STATED THAT THE MOTHER BOARD WAS REPLACED TO RESOLVE THE ISSUE AND THE MACHINE HAS BEEN RETURNED TO SERVICE. THERE WERE NO INJURIES, ADVERSE EVENTS, OR MEDICAL INTERVENTION REQUIRED TO THE PATIENT OR USER. THE BMT COULD NOT CONFIRM IF THE MOTHER BOARD WAS AVAILABLE TO BE RETURNED FOR ANALYSIS. UPON FURTHER FOLLOW UP, THE TECHNICIAN REPORTED THAT 30 MINUTES INTO TREATMENT THE TRANSDUCER WAS GETTING SOAKED WITH BLOOD RESULTING IN AN UNKNOWN AMOUNT OF BLOOD LOSS ON (B)(6) 2026. NO BLOOD WAS RETURNED TO THE P

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25587444 ↗
• InjuryMay 27, 2026Adverse Event Without Identified Device or Use Problem

  DURING FOLLOW-UP FOR A WORK ORDER REQUEST FOR A 2008T HEMODIALYSIS MACHINE, IT WAS REPORTED THAT A PATIENT HAD DIED. FOLLOW-UP WAS CONDUCTED WITH THE BIOMEDICAL TECHNICIAN (BIOMED) FROM THE USER FACILITY. THE BIOMED STATED THAT THERE WAS A SENTINEL EVENT (UNSPECIFIED) THAT OCCURRED WITH A PATIENT CONNECTED TO THE MACHINE. THE PATIENT EVENT WAS NOT SUSPECTED TO BE RELATED TO ANY ISSUE WITH THE MACHINE; HOWEVER, THE BIOMED WANTED TO DO FULL DUE DILIGENCE AND HAVE THE MACHINE INSPECTED BY A FIELD SERVICE TECHNICIAN (FST). THE BIOMED STATED THEY COMPLETED THEIR OWN TESTING AND EVALUATION AFTER THE EVENT, AND THE MACHINE PASSED ALL TESTS. THE BIOMED STATED THE PATIENT OUTCOME COULD NOT BE CONFIRMED. NO ADDITIONAL INFORMATION PERTAINING TO THE PATIENT EVENT WAS AVAILABLE. AN FST WAS SUBSEQUENTLY DISPATCHED TO THE FACILITY TO EVALUATE AND TEST THE MACHINE. IT WAS ONLY REPORTED THAT A PATIENT ADVERSE EVENT OCCURRED AND THE PATIENT DID NOT COMPLETE TREATMENT. DURING THE TESTING AND EVALUATION, THE MACHINE FAILED TO PASS THE ULTRAFILTRATION (UF) BALANCE ERROR. DURING THE 1-HOUR SIMULATED RUN, THE UF BALANCE ERROR FAILED. THE MAXIMUM ALLOWABLE ERROR IS +/- 30ML FOR A 1-HOUR SIMULATION AND THE

  Patient problems: Insufficient Information

  MAUDE report 25308912 ↗
• MalfunctionMay 21, 2026Thermal Decomposition of Device

  A user facility biomedical technician (biomed) reported finding thermal damage on the power cable going from the power supply to the motherboard of this 2008T Hemodialysis (HD) machine. Photos of the damaged cable were provided for review via email. The original issue was that the ultrafiltration (UF) check valve was leaking during a patient's HD treatment. There was no negative patient impact due to the leak. The patient was able to complete their treatment on the machine, and the UF was confirmed to be working properly. Following the treatment, the machine was removed from service for evaluation. The biomed replaced the UF check valve. While performing tests on the machine before returning it to service, a temperature issue was encountered. At first, the biomed said the temperature was stuck at 44° Celsius - it would not move up or down. Then the temperature started to fluctuate. The biomed attempted to resolve the issue by replacing several parts on the machine. They replaced the actuator-test board, the bibag interface board, the sensor board, the functional board, NTC-3/NTC-44, the bibag hydraulics assembly (box 1), the bibag distribution board (box 2), pressure trasnducer #10

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25246991 ↗
• MalfunctionMay 20, 2026Thermal Decomposition of Device

  A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS TECHNICAL SUPPORT THAT A 24 VOLT LOW ALARM OCCURRED DURING HEAT DISINFECT ON THIS 2008T HEMODIALYSIS (HD) MACHINE. THE BIOMED REPORTED THAT THE POWER SWITCH WIRES LOOKED BURNT/CORRODED. THEY REPLACED THE 24 VOLT CABLE AND THE POWER LOGIC CABLE. ADDITIONAL DETAILS WERE PROVIDED UPON FOLLOW-UP WITH THE BIOMED. THE BIOMED CONFIRMED THE MACHINE WAS GETTING A 24 VOLT LOW ALARM DURING HEAT DISINFECT. THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE EVENT. THE BIOMED SAID THE MACHINE HAS OVER 30,000 HOURS ON IT - THEY COULD NOT PROVIDE AN EXACT NUMBER. WHILE TROUBLESHOOTING THE ISSUE, THE BIOMED ENCOUNTERED CALIBRATION ISSUES. DURING THE MACHINE EVALUATION, THE BIOMED DISCOVERED THERMAL DAMAGE AND CORROSION ON THE WIRING HARNESS/TERMINAL THAT CONNECTS TO VALVE 108. THERE WAS NO DAMAGE ON VALVE 108. THE BIOMED ALSO NOTED A BURNING SMELL. THERE WERE NO SIGNS OF ANY SMOKE, SPARKS, OR FLAMES. THE BIOMED SAID THERE WAS NO OTHER THERMAL DAMAGE NOTED ON THE MACHINE. THE BIOMED REPLACED THE DAMAGED WIRING HARNESS/TERMINAL. THEY ALSO REPLACED THE 24 VOLT CABLE, THE POWER LOGIC CABLE, AND THE ENTIRE POWER SUPPLY. AFTER THE BIO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25234379 ↗
• MalfunctionApr 28, 2026Thermal Decomposition of Device; Melted

  A USER FACILITY BIOMEDICAL TECHNICIAN (BMT) REPORTED A DAMAGED POWER PLUG. THE BMT STATED THE BLACK WIRE WAS DAMAGED AND NEEDED THE PART NUMBER FOR THE POWER CORD ASSEMBLY. A PHOTO WAS PROVIDED. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT RECEIVED TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25023579 ↗
• MalfunctionApr 27, 2026Thermal Decomposition of Device

  A user facility biomedical technician (biomed) reported to technical support that a 2008T Hemodialysis machine was displaying the message ¿Failed sending data to Actuator Board¿. The biomed said the machine was recently repaired after the motherboard had ¿fried¿ the UI/MICS board. The biomed said they have since replaced the actuator-test board, the functional board, the UI/MICS board, the sensor board, and the motherboard. After having to replace the entire circuit, the biomed was wondering what next steps to take. The biomed was advised to return all replacement parts to the original machine due to the age of the machine that those parts came from. The only items replaced since the original issue are now the motherboard and the UI/MICS board. 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 24998408 ↗
• MalfunctionApr 27, 2026Thermal Decomposition of Device; Melted

  A USER FACILITY BIOMEDICAL TECHNICIAN (BMT) REPORTED A DAMAGED POWER PLUG. THE BMT STATED THE BLACK WIRE WAS DAMAGED AND NEEDED THE PART NUMBER FOR THE POWER CORD ASSEMBLY. A PHOTO WAS PROVIDED. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT RECEIVED TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24994543 ↗
• MalfunctionApr 17, 2026Thermal Decomposition of Device

  A USER FACILITY'S BIOMEDICAL TECHNICIAN (BMT) REPORTED THAT A 2008T HEMODIALYSIS (HD) MACHINE HAD A BURNT VALVE 100 WHICH CAUSED SMOKE AND A BURNING SMELL. THE BURNING SMELL AND SMOKING WERE NOTICED WHEN THE MACHINE WAS IN STANDBY/ SETUP/ COMPLETE MODE. THE PATIENT WAS NOT CONNECTED AND THERE WAS NO HARM TO ANY PATIENTS OR INDIVIDUALS BECAUSE OF THIS MALFUNCTION. THE BMT DID NOT REPORT MELTING, SPARK, FLAME, OR ARCING. THE VALVE WAS THE ORIGINAL FRESENIUS PART ON THE MACHINE. THE BMT REPORTED THAT THE MACHINE HAS NOT HAD ANY PAST PROBLEMS WITH FAILING THE ELECTRICAL LEAKAGE TEST. THE MACHINE HAS 36,124 HOURS AND IS PLUGGED INTO A HOSPITAL GRADE GROUND-FAULT CIRCUIT INTERRUPTER (GFCI) OUTLET. THE BMT REPORTED THAT VALVE 103 AND ITS HOUSING WERE DAMAGED DUE TO THE BURNT VALVE 100. THE BMT REPLACED VALVE 100 AS WELL AS VALVE 103 AND ITS HOUSING TO RESOLVE THE ISSUE. THE BMT REPORTED THAT THE MACHINE HAS BEEN RETURNED TO SERVICE WITHOUT ISSUE. THE COMPLAINT DEVICE IS AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION; HOWEVER, FOUR PHOTOS WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24911432 ↗
• DeathMar 26, 2026Adverse Event Without Identified Device or Use Problem

  A USER FACILITY NURSE MANAGER REPORTED TO FRESENIUS TECHNICAL SUPPORT THAT A HEMODIALYSIS (HD) PATIENT CODED WHILE ON A FRESENIUS 2008T MACHINE. THE NURSE MANAGER WAS REQUESTING FOR THE MACHINE TO BE VALIDATED. ADDITIONAL INFORMATION ABOUT THE EVENT WAS OBTAINED THROUGH FOLLOW-UP WITH THE NURSE MANAGER. IT WAS REPORTED THAT THIS PATIENT HAD PRE-EXISTING COMORBID CONDITIONS OF END STAGE RENAL DISEASE (ESRD), PROSTATE CANCER, CARDIOVASCULAR DISEASE, HEART FAILURE WITH EJECTION FRACTION 35%, AND NON-ST ELEVATION MYOCARDIAL INFARCTION (NSTEMI). THE PATIENT WAS RECEIVING HD VIA THE FRESENIUS 2008T MACHINE WHILE ADMITTED INTO THE HOSPITAL ON A CARDIAC FLOOR. IT WAS REPORTED THE PATIENT WAS IN THE HOSPITAL DUE TO HAVING HAD A NEW NON-ST ELEVATION MYOCARDIAL INFARCTION (NSTEMI) WITH PRE-EXISTING HEART FAILURE (WITH A REPORTED EJECTION FRACTION OF 35%). IT WAS CONFIRMED WITH THE NURSE MANAGER THAT THE NSTEMI WAS UNRELATED TO DIALYSIS. THE NURSE MANAGER STATED THERE WERE NO ISSUES WITH THE HD MACHINE RELATED TO THIS EVENT. IT WAS STATED THAT THE FRESENIUS HD MACHINE PASSED ALL PRE-TREATMENT SAFETY CHECKS. ADDITIONALLY, IT WAS REPORTED THAT THE PATIENT¿S PRE-TREATMENT VITAL SIGNS INCLUDED A B

  Patient problems: Cardiac Arrest; Heart Failure/Congestive Heart Failure

  MAUDE report 24706872 ↗
• MalfunctionFeb 26, 2026Thermal Decomposition of Device

  A USER FACILITY BIOMEDICAL TECHNICIAN (BMT) REPORTED THE 2008T HEMODIALYSIS (HD) MACHINE DIALYSIS MODE WAS GREYED OUT. THE BMT FOUND THE MOTHER BOARD AND EEPROM (ELECTRICALLY ERASABLE PROGRAMMABLE READ-ONLY MEMORY) HAD THERMAL DAMAGE. THE BMT WAS ADVISED TO REPLACE THE MOTHERBOARD AND EEPROM. THERE WAS NO PATIENT INVOLVEMENT OR INJURY NOTED AT INTAKE. UPON FOLLOW-UP, THE BMT STATED THE MACHINE DIALYSIS MODE WAS GREYED OUT DURING PREVENTATIVE MAINTENANCE (PM) AND CONFIRMED THERE WAS NO PATIENT INVOLVEMENT OR INJURY AS A RESULT OF THE REPORTED EVENT. THE BMT STATED UPON EXAMINATION IT WAS DETERMINED THE MOTHER BOARD AND EEPROM APPEARED TO HAVE THERMAL DAMAGE. THE BMT STATED THE REPLACEMENT MOTHERBOARD AND EEPROM WERE RECEIVED TODAY AND THE MACHINE REMAINS OUT OF SERVICE PENDING REPLACEMENT OF THE PARTS. OTHER THAN THE THERMAL DAMAGE NOTED ON THE MOTHERBOARD AND EEPROM, NO FURTHER THERMAL DAMAGE WAS FOUND ON ANY OTHER MACHINE COMPONENTS. THERE WAS NO SMOKE, BURNING SMELL, OR ANY SIGNS OF ARCING, 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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24461639 ↗
• MalfunctionJan 26, 2026Thermal Decomposition of Device

  A USER FACILITY'S BIOMEDICAL TECHNICIAN (BMT) REPORTED THAT A 2008T HEMODIALYSIS (HD) MACHINE DISPLAYED AN A.11 ALARM DURING SET UP. UPON FOLLOW UP, THE BMT SAID THAT HE REPLACED THE LP 956 AND LP 955 BOARDS TO RESOLVE THE REPORTED ISSUE. THE MACHINE IS BACK IN SERVICE. HE ALSO SAID THAT THE LP956 BOARD SHOWED SIGNS OF THERMAL DECOMPOSITION. 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 24178457 ↗
• MalfunctionDec 24, 2025Thermal Decomposition of Device; Thermal Decomposition of Device

  A Biomedical Technician (BMT) reported to Technical Support of a burning smell from the power supply assembly. During a rinse cycle a burning smell was noticed by staff coming from the power supply. Upon inspection by technical staff, some wires in the power supply seemed to be the source of the smell. This was the original power supply that came with the device. There was no patient involvement or injury noted at intake. Upon follow-up, the BMT reported that both the deaeration pump and the power supply assembly were burned. The BMT stated they had not yet received the parts to complete the repair the machine and resolve the reported issue. The machine was still out of service. It was confirmed there was no patient involvement associated with the reported issue. Photographic evidence was available.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23889274 ↗
• MalfunctionDec 19, 2025Inadequate Ultra Filtration; Inadequate Ultra Filtration

  A USER FACILITY'S BIOMEDICAL TECHNICIAN (BMT) REPORTED THAT A 2008T HEMODIALYSIS (HD) MACHINE'S ULTRAFILTRATION (UF) PUMP DID NOT TURN OFF ONCE THE UF GOAL WAS MET DURING A PATIENT'S HD TREATMENT. IT IS UNKNOWN IF THERE WAS ANY PATIENT SERIOUS INJURY OR ADVERSE EVENT. 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. 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 23850369 ↗
• MalfunctionDec 4, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS TECHNICAL SUPPORT THAT A 2008T MACHINE¿S BLOOD PUMP ROTOR CUT THROUGH 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 AND A PATIENT CARE TECHNICIAN (PCT) FAMILIAR WITH THE EVENT. THE MACHINE BEGAN ALARMING WITH AN AIR DETECTOR MESSAGE APPROXIMATELY TWO HOURS INTO THE HD TREATMENT. 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. IT WAS ALLEGED THAT A TUBING GUIDE ON THE BLOOD PUMP ROTOR CAME LOOSE AND DAMAGED THE TUBING. WHEN THE BLOODLINE WAS REMOVED FROM THE BLOOD PUMP ROTOR, A VISIBLE SLIT 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 PCT NOTICED THE LEAK, THE DIALYSIS TREATMENT WAS STOPPED. THE PATIENT¿S BLOOD WAS NOT RETURNED. ESTIMATED BLOOD LOSS (EBL) DUE TO THE EVENT WAS 250 ML. THE MACHINE WAS REMOVED FROM SERVICE FOR EVALUATION. THE PATIENT WAS ABLE TO

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23717361 ↗
• InjuryNov 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 23/OCT/2025, IT WAS REPORTED TO TECHNICAL SUPPORT BY A BIOMEDICAL TECHNICIAN (BMT) THAT A FRESENIUS 2008 T MACHINE WAS NOT HOLDING DATE AND TIME. TECHNICAL SUPPORT ADVISED TO SWAP THE SRAM ON THE FUNCTION BOARD AND PROVIDED PART NUMBER. DURING THE CALL, THE BMT ALSO STATED THAT A PATIENT RECEIVING HEMODIALYSIS IN THE HOSPITAL EXPERIENCED A DROP IN POTASSIUM (RESULT 3 MEQ/L) DURING HEMODIALYSIS TREATMENT WITH THE FRESENIUS 2008 T MACHINE (SERIAL NUMBER (B)(6)) WITH A DIALYSATE BATH OF 2K AND 2.5K. TECHNICAL SUPPORT ADVISED THAT A DROP IN POTASSIUM IS AN EXPECTED FINDING. THERE WERE NO ALLEGATIONS AGAINST THE DIALYSATE BATH. THE BMT COULD NOT CONFIRMED IF THE PATIENT REQUIRED MEDICAL INTERVENTION FOR HYPOKALEMIA. HOWEVER, IT WAS REPORTED THAT THE PATFIENT WAS ABLE TO COMPLETE THE HEMODIALYSIS TREATMENT WITH THE 2008 T MACHINE. THE BMT STATED THAT OUT OF PRECAUTION THE MACHINE WAS PULLED FROM SERVICE AND PUT THROUGH FUNCTIONAL TESTING. ACCORDING TO THE BMT, THE MACHINE PASSED ALL FUNCTIONAL TESTING POST EVENT (DESPITE MACHINE DATE/TIME ISSUE) AND WAS RETURNED TO SERVICE. THE BMT STATED THAT IT WAS ALSO DISCOVERED THAT THIS PATIENT HAS A HISTORY OF HYPOKALEMIA AND THAT THIS EVENT WA

  Patient problems: Electrolyte Imbalance

  MAUDE report 23546858 ↗
• MalfunctionNov 11, 2025Thermal Decomposition of Device; Thermal Decomposition of Device

  A user facility's biomedical technician (BMT) reported that a 2008T Hemodialysis (HD) Machine's valve 103 started smoking and cracked open during chemical disinfection. 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 valve was the original Fresenius part on the machine. The BMT reported that there was no melting, 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 40,000 hours and is plugged into a hospital grade ground-fault circuit interrupter (GFCI) outlet. The BMT replaced the bibag module, which resolved the issue. The BMT reported that the machine has been returned to service without issue. The complaint sample is not available to be returned to the manufacturer for physical evaluation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23525623 ↗
• MalfunctionOct 30, 2025Thermal Decomposition of Device; Thermal Decomposition of Device

  A BIOMEDICAL TECHNICIAN (BMT) REPORTED TO TECHNICAL SUPPORT THAT A 2008T MACHINE DISPLAYED INTERMITTENTLY A 'BLOOD LEAK NOT CAL' MESSAGE, AFTER THE MACHINE HAD BEEN OFF. THE BMT HAD SWAPPED THE BLOOD LEAK DETECTOR, ACTUATOR-TEST BOARD AND CABLE, SENSOR BOARD AND CABLE, FUNCTION BOARD AND EEPROM, DISTRIBUTION BOARD AND MOTHER BOARD. THE BLOOD LEAK HAD BEEN CALIBRATED. THE BMT WAS ADVISED TO SWAP HYDRAULICS TO SEE IF ITS A CARD CAGE OR HYDRAULICS ISSUE. UPON FOLLOW-UP, THE BMT STATED THAT THE BLOOD LEAK MODULE WAS BAD AND THEY WERE USING AN OLD ONE THINKING IT WAS A NEW ONE. WHEN THE BMT REPLACED IT FOR A NEW ONE, THEY NOTED THERMAL DAMAGE ON THE CABLE. NO PARTS WERE RETURNED FOR EVALUATION. NO PHOTOS WERE AVAILABLE. THE PART AND LOT NUMBERS OF THE REPLACED COMPONENT COULD NOT BE PROVIDED AT THE TIME OF THE CALL. IT WAS CONFIRMED THAT THERE WAS NO PATIENT INVOLVEMENT, HARM, OR ADVERSE EVENTS ASSOCIATED WITH THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23423831 ↗
• MalfunctionOct 8, 2025No Audible Alarm; Fluid/Blood Leak; No Audible Alarm; Fluid/Blood Leak

  A USER FACILITY REPORTED THAT A DIALYZER BLOOD LEAK OCCURRED THREE MINUTES AFTER THE INITIATION OF THE PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE BLOOD LEAK WAS NOTED AS BEING AN INTERNAL BLOOD LEAK. THE LEAK WAS VISUALLY OBSERVED INSIDE THE DIALYZER. THE MACHINE, A FRESENIUS 2008T MACHINE, DID NOT ALARM WITH A BLOOD LEAK ALARM. BLOOD LEAK TEST STRIPS WERE USED AND TESTED POSITIVE FOR THE PRESENCE OF BLOOD. THERE WAS NO DEFECT OR DAMAGE NOTED ON THE DIALYZER. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 100-300 ML. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THIS EVENT. THE PATIENT¿S TREATMENT WAS COMPLETED SUCCESSFULLY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23246533 ↗
• MalfunctionSep 16, 2025Thermal Decomposition of Device; Sparking; Thermal Decomposition of Device; Sparking

  A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO TECHNICAL SERVICE THAT A SPARK WAS NOTED COMING FROM THE BLOOD PUMP MODULE OF A FRESENIUS 2008T MACHINE. THE BIOMED STATED THE BLOOD PUMP MODULE WAS BRAND NEW (OUT OF THE BOX). ADDITIONAL DETAILS WERE PROVIDED UPON FOLLOW-UP WITH THE BIOMED. THE BIOMED WAS REPLACING THE BLOOD PUMP MODULE BECAUSE OF AN A.22 ERROR CODE THAT THE MACHINE WAS DISPLAYING. THE SPARK OCCURRED WHEN THE MACHINE WAS TURNED ON AND THE MODULE WAS PUSHED INTO PLACE. THE SPARK CAME FROM THE METAL ON THE BOARD MOUNTS. THE BIOMED SAID THE BOARD MOUNTS ON THE PART WERE WEAK, AND THE BOARD WAS MOVING AROUND A LOT. AFTER THE SPARK OCCURRED, THE BIOMED NOTICED A BURN MARK ON THE METAL FRAME BEHIND THE BLOOD PUMP MODULE. A PHOTO OF THIS WAS PROVIDED FOR REVIEW. THE FUNCTIONAL BOARD FAILED AS A RESULT OF THE BLOOD PUMP ISSUE. THE BIOMED WAS ABLE TO FIX THE MACHINE BY REPLACING THE BLOOD PUMP MODULE AND FUNCTIONAL BOARD. THE BIOMED NOTED THAT THE REPLACEMENT BLOOD PUMP MODULE HAD STRONGER MOUNTS (AN OLDER DESIGN). NO DAMAGE WAS IDENTIFIED ON ANY OTHER COMPONENTS. THERE WAS NO BURNING SMELL, AND THERE WERE NO SIGNS OF ANY SMOKE, SPARKS, OR FLAMES. THE MACHINE HAD 3

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23060009 ↗