2008® Series Hemodialysis Machines 190895Recalls & reported problems

Summary

The FDA's MAUDE database contains 60 adverse event reports that list this exact device (DI 00840861100927), received between Oct 21, 2015 and Jul 20, 2026 — classified as 2 deaths, 4 injuries, 54 malfunctions.

The most frequently reported specific device problem is “Thermal Decomposition of Device” (29 reports).

3 FDA recall records name this device's identifier, 2 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-0031-2024 · Root cause: Device Design · Recall details · FDA record ↗

3. 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 60 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 20, 2026Thermal Decomposition of Device

  A user facility reported to Fresenius that a 2008T Hemodialysis (HD) machine was giving a conductivity low alarm. A field service technician (FST) was dispatched to the facility to evaluate the machine. The 2008T machine was out of service when the FST arrived onsite. The FST ran the machine in rinse and encountered a flow inlet error and check acid pump alarm. They noticed that the diasafe filter required replacement as it was thirty days past due. The FST indicated that this was possibly causing the flow inlet error. The diasafe filter was replaced. The FST noticed a burning smell, and thermal decomposition was identified once the distribution box was opened. The FST stated the distribution box 2 board and cable were burnt due to leaked concentrate. Photos were provided for review. The FST stated valve 105 looked rusted, and the acid port pressure transducer had signs of thermal decomposition - both parts are components of the distribution board assembly. The FST replaced the distribution board assembly and cable. The machine was still giving a flow inlet error after these parts were replaced. The biomed then replaced the actuator board and the bibag interface board and the alarm

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25882185 ↗
• MalfunctionMar 18, 2026Thermal Decomposition of Device; Melted; Smoking

  It was reported to Fresenius that smoke was coming from the back of the power supply on this 2008T Hemodialysis (HD) machine and that a burning smell was noted. A Fresenius field service technician (FST) was dispatched to the facility to evaluate the 2008T machine. Additional details were provided upon follow-up with the FST. The FST said the staff called a "code red" from the smoke, but they didn't mention anything about a fire or smoke alarm. The machine was in idle mode when this occurred, and there was no patient involved. The FST said the facility only has hospital grade ground fault circuit interrupter (GFCI) outlets on the treatment floor as far as they know. The FST inspected the card cage and power supply, and they observed no issues with the parts. The machine was then connected to a water source, and once connected a steady stream of water began leaking from valve 103 of the bibag hydraulic module. The valve seemed to be the original Fresenius part on the machine. The valve had melted, causing the plastic housing to melt and smoke. The rest of the module was inspected with no visual issues noted. No other noticeable damage was noted during the machine inspection. The FST

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24635021 ↗
• MalfunctionSep 9, 2025Thermal Decomposition of Device; Thermal Decomposition of Device

  A HEMODIALYSIS (HD) USER FACILITY REPORTED TO FRESENIUS TECHNICAL SUPPORT THAT A 2008T MACHINE FAILED NEGATIVE STABILIZATION DURING SYSTEM TESTING. A FAILED PRESSURE TEST ALARM WENT OFF AFTER THE TESTS WERE COMPLETED AND THE MACHINE WAS REMOVED FROM THE TREATMENT FLOOR. A FRESENIUS FIELD SERVICE TECHNICIAN (FST) WAS DISPATCHED TO THE USER FACILITY TO FURTHER EVALUATE THE MACHINE. AFTER THE MACHINE WAS MOVED OFF THE TREATMENT FLOOR, IT WOULD NOT POWER BACK ON. UPON THE FST¿S ARRIVAL, IT WAS CONFIRMED THE MACHINE WAS PLUGGED INTO A GROUND-FAULT CIRCUIT INTERRUPTER (GFCI) OUTLET. DURING EVALUATION OF THE MACHINE¿S POWER SUPPLY, A BURNT CAPACITOR WAS IDENTIFIED AND A BURNING SMELL WAS OBSERVED. DUE TO THE CONDITION AND AGE OF THE POWER SUPPLY, THE DECISION WAS MADE TO REPLACE THE ENTIRE ASSEMBLY. AFTER REPLACING THE POWER SUPPLY ASSEMBLY, THE MACHINE WAS ABLE TO BE POWERED ON. THE FST PERFORMED PRESSURE TESTING (DEAERATION AND LOADING) AFTER POWERING ON THE MACHINE. THE LOADING PRESSURE REGULATOR WAS MAXED OUT AND THE LOADING PRESSURE COULD NOT BE INCREASED. THE FST REPLACED THE REGULATOR AND THE PRESSURES WERE THEN ADJUSTED. DRIPS OF WATER WERE OBSERVED COMING FROM THE DIALYSATE CONNE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23011700 ↗
• MalfunctionAug 26, 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 BIOMED WAS REPLACING A FAILED DIASAFE FILTER WHEN A WIRE ON THE V28 WIRING HARNESS GOT CAUGHT BETWEEN THE ACID PUMP AND THE HYDRAULIC FRAME AND BURNED. THE BIOMED DID NOT OBSERVE ANY BURNING SMELL, SMOKE, SPARK, FLAME, ARCING, OR ANY OTHER VISIBLE HEAT OR ELECTRICAL DAMAGE RELATED TO THE BURNED WIRE. THE BIOMED COULD NOT CONFIRM THE OPERATING HOURS OF THE MACHINE BUT STATED THAT THE PART IS THE ORIGINAL FRESENIUS PART ON THE MACHINE. THE BIOMED STATED THAT THE WIRING HARNESS WAS REPLACED, WHICH RESOLVED THE MACHINE ISSUE, AND THAT THE MACHINE IS BACK IN SERVICE WITHOUT ANY ISSUES. ADDITIONALLY, THE BIOMED CONFIRMED THAT THERE WAS NO DAMAGE OBSERVED ON ANY OTHER COMPONENTS, OR ANY OTHER ADDITIONAL ISSUES, ASSOCIATED WITH THE BURNED WIRE. THE BIOMED CONFIRMED THAT 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 BIOMED CONFIRMED THAT THE SAMPLE WAS DISCARDED AND IS NOT AVAILABLE FOR RETURN TO THE MANUFACTURER FOR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22895920 ↗
• MalfunctionSep 25, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE FACILITY ADMINISTRATOR (FA) FROM A HEMODIALYIS (HD) USER FACILITY REPORTED THAT A 2008T HD MACHINE HAD A BLOOD PUMP ROTOR FAILURE THAT OCCURRED DURING A PATIENT¿S TREATMENT. WITHIN THE FIRST TWENTY MINUTES OF THE TREATMENT, THE STAFF OBSERVED A SMALL BLOOD LEAK COMING FROM THE BLOOD PUMP AND LEAKING DOWN THE FRONT OF THE MACHINE. IT WAS UNKNOWN IF THE MACHINE ALARMED. THE TREATMENT WAS TERMINATED, AND THE PATIENT'S BLOOD WAS RETURNED. FOLLOWING THE EVENT, THE FA SAID THE STAFF WAS REEDUCATED AND INSTRUCTED NOT TO RETURN THE BLOOD IF THIS WERE TO REOCCUR. THE DOCTOR WAS NOTIFIED OF THE EVENT. AS A PRECAUTION, THE PATIENT WAS GIVEN PROPHYLACTIC ANTIBIOTICS AND HAD TWO BLOOD CULTURES TAKEN. HOWEVER, THE PATIENT WAS CONFIRMED TO BE ASYMPTOMATIC. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE MEDICAL INTERVENTION. THE PATIENT WAS RE-SETUP WITH NEW SUPPLIES ON A DIFFERENT MACHINE WHERE THEY WERE ABLE TO COMPLETE THEIR TREATMENT. THE MACHINE THAT THE LEAK OCCURRED ON WAS REMOVED FROM SERVICE. UPON REMOVAL OF THE COMBI SET BLOODLINES, A CUT WAS IDENTIFIED ON THE TUBING SEGMENT THAT SITS IN THE BLOOD PUMP ROTOR. THE FA CONFIRMED THAT THE BLOODLINES WERE INSPECTED PRIOR TO

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20306933 ↗
• MalfunctionNov 1, 2023Thermal Decomposition of Device; Thermal Decomposition of Device

  A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED FINDING THERMAL DAMAGE ON A FRESENIUS 2008T HEMODIALYSIS (HD) MACHINE. THE BIOMED WAS PREPARING TO PERFORM A BLUE STAR UPGRADE ON THE MACHINE WHEN THEY NOTICED A BURNT DIODE ON THE MOTHERBOARD. THE MOTHERBOARD WAS CONFIRMED TO BE AN ORIGINAL FRESENIUS PART. NO DAMAGE WAS IDENTIFIED ON ANY OTHER COMPONENTS. THE BIOMED DID NOT NOTICE A BURNING SMELL. IT WAS CONFIRMED THERE WERE NO SIGNS OF ANY SMOKE, SPARKS, FLAMES, OR MELTED COMPONENTS. THE MACHINE HAD APPROXIMATELY 12,000 HOURS ON IT. THE MACHINE WAS PLUGGED INTO A HOSPITAL GRADE GROUND-FAULT CIRCUIT INTERRUPTER (GFCI) OUTLET AND HAD NO PREVIOUS HISTORY OF FAILING THE ELECTRICAL LEAKAGE TEST. TO RESOLVE THE REPORTED ISSUE, THE BIOMED REPLACED THE MOTHERBOARD. THEY WERE THEN ABLE TO CONTINUE WITH THE UPGRADE. THE MACHINE UPGRADE WAS COMPLETED, AND THE MACHINE WAS PUT BACK IN SERVICE. THE DAMAGED MOTHERBOARD WAS NOT AVAILABLE TO BE RETURNED FOR EVALUATION AS IT HAD BEEN DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18049964 ↗
• InjuryFeb 15, 2023Inadequate Ultra Filtration; Inadequate Ultra Filtration

  A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS THAT A PATIENT WAS HEAVIER THAN EXPECTED AFTER COMPLETING HEMODIALYSIS TREATMENT ON A 2008T MACHINE. THE BIOMED STATED THAT THE ULTRAFILTRATION (UF) PUMP APPEARS TO BE WORKING WITHOUT ANY ISSUES. THE BIOMED ALSO REPORTED THE LOW (POSITIVE) TRANSMEMBRANE PRESSURE (TMP) DROPPED TO AROUND 0 MMHG DURING TREATMENT. DURING FOLLOW-UP THE BIOMED STATED THE MACHINE WAS EVALUATED AND NO UF ISSUES WERE ENCOUNTERED. THE BIOMED SUSPECTS THAT USER ERROR WAS THE CAUSE OF THE REPORTED ISSUE HOWEVER THEY WERE NOT PRESENT AT THE TIME OF THE EVENT. THE BIOMED STATED THAT THE PATIENT RETURNED THE FOLLOWING DAY FOR AN ADDITIONAL TREATMENT TO REMOVE THE EXCESS FLUID. A FIELD SERVICE TECHNICIAN (FST) WAS CALLED TO EVALUATE THE MACHINE AND COMPLETED THE EVALUATION ON 06/FEB/2023. THE INTERIOR HYDRAULICS WERE INSPECTED. FUNCTIONAL CHECKS WERE PERFORMED IN ACCORDANCE TO THE UF PROBLEM IDENTIFICATION PROCEDURE CHECKLIST AND PASSED ALL TESTS. THE DIALYSATE PRESSURE WAS CALIBRATED AS A PREVENTATIVE MEASURE. THE FST COULD NOT DUPLICATE THE LOW POSITIVE TMP ISSUE THAT WAS REPORTED. THE MACHINE PASSED ALL FUNCTIONAL TESTING. NO PARTS HAVE BEEN R

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 16378208 ↗
• MalfunctionAug 12, 2022Thermal Decomposition of Device; Thermal Decomposition of Device

  A BIOMEDICAL TECHNICIAN (BIOMED) AT A USER FACILITY REPORTED THAT A FRESENIUS 2008T HEMODIALYSIS (HD) MACHINE HAD A BURNED MOTHERBOARD AND A BURNED USER INTERFACE (UI) BOARD. THE BURNED BOARD WAS NOTICED DURING MACHINE REPAIR AFTER IT WAS REPORTED THAT DATA FAILED TO SEND TO THE ACTUATOR. THE BIOMED STATED THAT FLUID LEAKED INTO THE CARD CAGE OF THE MACHINE AND BURN MARKS COULD BE OBSERVED ON BOTH BOARDS. 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 APPROXIMATELY 15,000 HOURS AND THE BOARDS WERE THE ORIGINAL FRESENIUS PARTS ON THE MACHINE. THE BIOMED REPORTED THAT THERE WAS NO DAMAGE OBSERVED ON ANY OTHER COMPONENTS, OR ANY OTHER ADDITIONAL ISSUES, ASSOCIATED WITH THE BURNED AND BURNED BOARDS. THE BIOMED STATED THE MOTHERBOARD, UI BOARD, AND TEST-ACTUATOR BOARD WERE REPLACED TO RESOLVE THE REPORTED ISSUE. THE MACHINE PASSED FUNCTIONAL TESTING AND WAS RETURNED TO SERVICE. THE PARTS ARE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR A PHYSICAL EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15220683 ↗
• MalfunctionJul 15, 2022Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS THAT A PATIENT EXPERIENCED BLOOD LOSS AFTER A 2008T MACHINE POWERED DOWN TWICE DURING THEIR HEMODIALYSIS (HD) TREATMENT. THE MACHINE COULD BE RESTARTED AFTER THE FIRST OCCURRENCE BUT NOT AFTER THE SECOND OCCURRENCE WHICH PREVENTED THE PATIENT'S BLOOD FROM BEING RETURNED. ADDITIONAL INFORMATION REGARDING THE TREATMENT WAS REQUESTED HOWEVER A RESPONSE WAS NOT RECEIVED. IT WAS STATED IN THE INITIAL REPORT THAT THE PATIENT DID NOT EXPERIENCE AN ADVERSE EVENT OR SERIOUS INJURY AS A RESULT OF THE REPORTED ISSUE. THE PATIENT'S ESTIMATED BLOOD LOSS (EBL) WAS NOT PROVIDED. TREATMENT WAS NOT RESTARTED AFTER THE REPORTED ISSUE HAD OCCURRED. THE BIOMED STATED DURING FOLLOWUP THAT THE FRONT PANEL KEYPAD AND POWER LOGIC BOARD WERE REPLACED TO RESOLVE THE REPORTED ISSUE. THE MACHINE HAS BEEN RETURNED TO SERVICE. THE POWER LOGIC BOARD IS AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR A PHYSICAL EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15029807 ↗
• MalfunctionJul 5, 2022Melted; Melted

  A BIOMEDICAL TECHNICIAN (BIOMED) REPORTED THAT A HEMODIALYSIS (HD) MACHINE WAS RINSED AND IN THE PROCESSES OF THE RINSE, A FLOW INLET ERROR ALARM OCCURRED. THE MANDATORY RINSE MODE COMPLETED WITHOUT ANY FLOW ERROR ALARMS AND VALVE 103 HYDROCHAMBER OUTLET VALVE SHOWED THE BLACK HOUSING MELTED FROM THE INSIDE. THE VALVE WAS REPLACED AND THE FLOW INLET ERROR ALARM WAS STILL PRESENT. THE BIOMED WAS REQUESTED TO HAVE THE BIBAG HYDRAULIC ASSEMBLY REPLACED. THE PART WAS ORDERED. UPON FOLLOW-UP WITH THE BIOMED, IT WAS REPORTED THEY DID NOT OBSERVE ANY BURNING SMELL, SMOKE, SPARK, FLAME, ARCING, OR ANY OTHER VISIBLE HEAT OR ELECTRICAL DAMAGE RELATED TO THE MELTING FOUND ON THE VALVE. THE BIOMED CONFIRMED THE MACHINE HAD 15,257.4 HOURS. THE BIOMED STATED THAT THE REPLACED VALVE WAS THE ORIGINAL FRESENIUS PART ON THE MACHINE. THE BIOMED STATED THE MACHINE REMAINS OUT OF SERVICE PENDING REPLACEMENT OF THE BIBAG HYDRAULIC ASSEMBLY. ADDITIONALLY, THE BIOMED CONFIRMED THERE WAS NO DAMAGE OBSERVED ON ANY OTHER COMPONENTS, OR ANY OTHER ADDITIONAL ISSUES, ASSOCIATED WITH THE MELTED VALVE. THE BIOMED CONFIRMED THAT A PATIENT WAS NOT CONNECTED TO THE MACHINE AT THE TIME OF THE INCIDENT AND THERE WAS N

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14917487 ↗
• MalfunctionJun 20, 2022Thermal Decomposition of Device; Melted; Smoking; Thermal Decomposition of Device; Melted; Smoking

  A BIOMEDICAL TECHNICIAN (BIOMED) AT A USER FACILITY REPORTED THAT THE POWER SUPPLY OF A FRESENIUS 2008T HEMODIALYSIS (HD) MACHINE HAD SUSTAINED BURN DAMAGE. THE BURNED POWER CONTROL BOARD WAS INITIALLY NOTICED DURING MACHINE REPAIR AFTER THE MACHINE WAS PULLED FROM SERVICE FOR FAILING TO POWER ON. THE BIOMED INITIALLY OBSERVED BLOWN FUSES ON THE BOARD AND ATTEMPTED TO REPLACED THEM AND REBOOT THE MACHINE AT WHICH POINT THE POWER SUPPLY SUSTAINED FURTHER BURN DAMAGE. THE BIOMED STATED THAT THE FUSES REBLEW, THE POWER CONTROL BOARD BURNED, THE CAPACITOR CHARRED, A YELLOW PIECE PROJECTED FROM THE MACHINE, AND THE WIRE CONNECTING TO THE POWER SWITCH MELTED. THE BIOMED CONFIRMED THAT A BURNING SMELL, SMOKE, SPARK, FLAME, AND ARCING WERE OBSERVED. THE BIOMED STATED THAT THERE WAS NOT ENOUGH SMOKE PRODUCED BY THE MACHINE TO TRIGGER A FACILITY SMOKE DETECTOR. 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 APPROXIMATELY 13,715 HOURS AND THE POWER SUPPLY WAS THE ORIGINAL FRESENIUS PART ON THE MACHINE. THE BIOMED CONFIRMED THAT THE MACHINE DOES NOT HAVE A HISTORY OF FAILIN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14743528 ↗
• InjuryMar 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 16/FEB/2022, FRESENIUS BECAME AWARE THIS PATIENT WITH ACUTE KIDNEY INJURY (AKI) ON HEMODIALYSIS (HD) FOR RENAL REPLACEMENT THERAPY (RRT) ¿CODED¿ DURING HD THERAPY, AND LATER EXPIRED ON 14/FEB/2021. THE PATIENT WAS NOT UNDERGOING RRT PRIOR TO ADMISSION TO THE HOSPITAL. MEDICAL RECORDS INDICATE THE PATIENT WAS HOSPITALIZED ON (B)(6)2022 FOR WORSENING BILATERAL LOWER EXTREMITY EDEMA, CHILLS, CELLULITIS, WEIGHT GAIN, AND PAIN. AN ELECTROCARDIOGRAM (EKG) PERFORMED IN THE EMERGENCY ROOM (ER) WAS UNREMARKABLE FOR ANY ACUTE PROCESSES (CONFIRMED CHRONIC ATRIAL FIBRILLATION), AND A CHEST X-RAY REVEALED INCREASED VASCULAR INTERSTITIAL MARKINGS. THE PATIENT WAS DEEMED ¿FLUID OVERLOADED,¿ STARTED ON AN INTRAVENOUS (IV) LASIX AND NEPHROLOGY/CARDIOLOGY CONSULTS WERE ORDERED. MUCH OF THE HOSPITALIZATION IS UNKNOWN GIVEN THE LIMITED DAY-TO-DAY DETAIL, HOWEVER THE RECORDS SHOW THE PATIENT WAS STARTED ON HEMODIALYSIS (HD) ON (B)(6)2022 (2ND TREATMENT ON (B)(6)2022), AFTER RECEIVING A RIGHT INTRAJUGULAR (IJ) HD CATHETER (NOT A FRESENIUS PRODUCT). THE PATIENT WAS REPORTEDLY NOT RESPONDING TO DIURETIC THERAPY AND REQUIRED INCREASED ULTRAFILTRATION GIVEN HER CARDIAC INSTABILITY. ON (B)(6)2022, THE PAT

  Patient problems: Bradycardia; Cardiac Arrest; Loss of consciousness; Low Blood Pressure/ Hypotension

  MAUDE report 13709158 ↗
• MalfunctionDec 6, 2021Thermal Decomposition of Device; Thermal Decomposition of Device

  A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS THAT THE 2008T MACHINE WOULD NOT POWER ON. DURING FOLLOW-UP WITH THE BIOMED IT WAS CONFIRMED THAT 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 BIOMED STATED THAT THE REPLACING THE POWER SUPPLY RESOLVED THE REPORTED ISSUE. THE BIOMED STATED THAT THE BLOOD PUMP ALSO NEEDED TO BE REPLACED AFTER ISSUES WERE EXPERIENCED WITH IT. THE COMPLAINT SAMPLES WERE RETURNED TO THE MANUFACTURER FOR A PHYSICAL EVALUATION. UPON PHYSICAL EVALUATION OF THE POWER SUPPLY BY THE MANUFACTURER, EVIDENCE OF THERMAL DAMAGE TO THE ROCKER SWITCH WAS IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12936749 ↗
• DeathNov 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS TECHNICAL SUPPORT THAT A HOSPITALIZED PATIENT EXPERIENCED AN ADVERSE EVENT DURING A HEMODIALYSIS (HD) TREATMENT. THE BIOMED WAS ASKED TO PERFORM FUNCTIONAL CHECKS ON THE 2008T HD MACHINE THAT WAS BEING UTILIZED. THERE WAS NO SPECIFIC ALLEGATION THE EVENT WAS DUE TO A DEFICIENCY OR MALFUNCTION OF ANY FRESENIUS PRODUCT. ADDITIONAL INFORMATION WAS OBTAINED THROUGH FOLLOW-UP WITH A HOSPITAL HD REGISTERED NURSE (HDRN) FAMILIAR WITH THE EVENT. THE HDRN REPORTED THAT THE PATIENT BECAME BRADYCARDIC DURING HD TREATMENT AND SUBSEQUENTLY EXPIRED. THE PATIENT WAS INITIALLY ADMITTED TO THE HOSPITAL ON (B)(6) 2021 WITH A DIAGNOSIS OF PNEUMONIA. THE PATIENT BECAME CRITICALLY ILL DURING THIS ADMISSION, AND IT WAS DETERMINED THE PATIENT¿S KIDNEYS WERE FAILING. THE PATIENT WAS GIVEN AN HD TREATMENT ON 10/OCT/2021 WITH A HOSPITAL PROVIDED 2008T HD MACHINE. IT WAS CONFIRMED THE PATIENT WAS NOT ON CHRONIC RENAL REPLACEMENT THERAPY AND THIS WAS THE FIRST HD TREATMENT THEY UNDERWENT. ONE HOUR AND FORTY-THREE MINUTES FOLLOWING THE INITIATION OF THE HD TREATMENT (TOTAL INTENDED TREATMENT TIME WAS TWO HOURS), THE PATIENT BECAME BRADYCARDIC, AND HD WAS D

  Patient problems: Bradycardia

  MAUDE report 12776256 ↗
• MalfunctionSep 16, 2021Fail-Safe Did Not Operate; Fail-Safe Did Not Operate

  A FRESENIUS REGIONAL SALES MANAGER REPORTED THAT A DIALYZER BLOOD LEAK WAS OBSERVED AFTER THE COMPLETION OF THE PATIENT¿S HEMODIALYSIS (HD) TREATMENT. UPON FOLLOW UP, IT WAS REPORTED THAT THE BLOOD LEAK WAS INTERNAL AND VISUALLY OBSERVED ON THE HANSEN CONNECTOR TUBING AFTER THE PATIENT¿S TREATMENT WAS SUCCESSFULLY COMPLETED. THE MACHINE, A FRESENIUS 2008T MACHINE, DID NOT ALARM FOR A BLOOD LEAK DURING TREATMENT. BLOOD LEAK TEST STRIPS WERE NOT USED TO CONFIRM THE OBSERVED BLOOD. THERE WAS NO ESTIMATED BLOOD LOSS (EBL) REPORTED, NOR ANY PATIENT INJURY, ADVERSE EVENTS, OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THIS EVENT. THE PATIENT COMPLETED TREATMENT SUCCESSFULLY ON THE SAME MACHINE WITH THE SAME SUPPLIES. THE DIALYZER SAMPLE WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12485762 ↗
• MalfunctionJul 20, 2021Fluid/Blood Leak; Fluid/Blood Leak

  A BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO TECHNICAL SUPPORT THAT A FRESENIUS 2008T HEMODIALYSIS (HD) MACHINE HAD AN ¿ACT. BLOOD PUMP FAILED¿ MESSAGE THAT APPEARED IN THE LAST THREE MINUTES OF A PATIENT¿S TREATMENT. THE BIOMED STATED THERE WAS NO PATIENT HARM, BUT INDICATED THE EVENT RESULTED IN MINOR BLOOD LOSS. BLOOD FROM THE ARTERIAL LINE WAS RETURNED, HOWEVER, BLOOD FROM THE VENOUS LINE HAD CLOTTED AND COULD NOT BE RETURNED. THE PATIENT¿S ESTIMATED BLOOD LOSS WAS SAID TO BE 200 ML. THE PATIENT DID NOT COMPLETE THEIR TREATMENT. HOWEVER, THERE WAS NO PATIENT INJURY, NO ADVERSE EFFECTS WERE EXPERIENCED, AND NO MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THE REPORTED EVENT. FOLLOWING THE EVENT, THE MACHINE WAS PULLED FROM SERVICE FOR EVALUATION. THE BIOMED COULD NOT DUPLICATE THE ALARM. THEY RAN MULTIPLE TESTS, INCLUDING A THREE-HOUR MOCK TREATMENT WITH SALINE BAGS TO SIMULATE A REAL TREATMENT, AND THERE WERE NO ISSUES. THE ALARM DID NOT REOCCUR DURING THE MOCK TREATMENT AND THE BIOMED DID NOT NEED TO REPLACE ANY PARTS ON THE MACHINE. UPON FOLLOW-UP, IT WAS CONFIRMED THAT THE MACHINE WAS READY TO BE RETURNED TO SERVICE. AS NO PARTS WERE REPLACED, A SAMPLE WAS NOT AVAILABLE T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12200321 ↗
• MalfunctionJul 12, 2021Thermal Decomposition of Device; Thermal Decomposition of Device

  A BIOMEDICAL TECHNICIAN (BIOMED) AT A USER FACILITY REPORTED THAT BRUSHES ON THE DEAERATION MOTOR OF A FRESENIUS 2008T HEMODIALYSIS (HD) MACHINE WERE BURNED. THE BURNED BRUSHES WERE NOTICED DURING MACHINE REPAIR AFTER THE MACHINE ALARMED WITH A FLOW INLET ERROR. THE BIOMED STATED THAT THEY DID NOT OBSERVE ANY BURNING SMELL, SMOKE, SPARK, FLAME, ARCING, OR ANY OTHER VISIBLE HEAT OR ELECTRICAL DAMAGE RELATED TO THE BURNING ON THE DEAERATION MOTOR. 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 BIOMED REPORTED THAT THERE WAS NO DAMAGE OBSERVED ON ANY OTHER COMPONENTS, OR ANY OTHER ADDITIONAL ISSUES, ASSOCIATED WITH THE BURNED BRUSHES. THE BIOMED STATED AT THE TIME OF FOLLOWUP THAT THE MACHINE WILL REMAIN OUT OF SERVICE UNTIL THE ARRIVAL OF A REPLACEMENT DEAERATION MOTOR. THE COMPLAINT DEVICE IS AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12153511 ↗
• MalfunctionJul 12, 2021Thermal Decomposition of Device; Thermal Decomposition of Device

  A BIOMEDICAL TECHNICIAN (BIOMED) AT A USER FACILITY REPORTED THAT COMPONENTS ON TWO ACTUATOR BOARDS OF A FRESENIUS 2008T HEMODIALYSIS (HD) MACHINE HAVE BURNED UP. THE BURNED BOARDS WERE NOTICED DURING MACHINE REPAIR AFTER THE MACHINE INITIALLY EXPERIENCED AN ISSUE WITH LOW CONDUCTIVITY. 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. ADDITIONAL INFORMATION WAS REQUESTED, HOWEVER A RESPONSE WAS NOT RECEIVED. THE BIOMED DID NOT REPORT THAT THERE WAS DAMAGE OBSERVED ON ANY OTHER COMPONENTS, OR ANY OTHER ADDITIONAL ISSUES, ASSOCIATED WITH THE BURNED ACTUATOR BOARDS. THE ACTUATOR BOARDS WERE NOT RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12153324 ↗
• MalfunctionOct 26, 2020Thermal Decomposition of Device; Melted; Thermal Decomposition of Device; Melted

  A BIOMEDICAL TECHNICIAN (BIOMED) AT A USER FACILITY REPORTED THAT A FRESENIUS 2008T HEMODIALYSIS (HD) MACHINE HAD A BURNT POWER PLUG. 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 BIOMED REPORTED THAT THE POWER PLUG CHARRED AND MELTED AND MADE A BURNING SMELL, HOWEVER THERE WAS NO SMOKE, SPARK, FLAME, OR ARCING OBSERVED. THE BIOMED REPORTED THAT THE MACHINE HAS NOT HAD ANY PAST PROBLEMS WITH FAILING THE ELECTRICAL LEAKAGE TEST. THE MACHINE IS PLUGGED INTO A HOSPITAL GRADE GROUND-FAULT CIRCUIT INTERRUPTER (GFCI) OUTLET. THE POWER CORD WAS REPLACED, BUT THE MACHINE REMAINED UNABLE TO POWER ON. THE BIOMED THEN REPLACED THE POWER SUPPLY, AT WHICH POINT THE MACHINE WAS ABLE TO POWER ON. THE POWER SUPPLY DID NOT APPEAR BURNED, CHARRED, MELTED, OR BLACK. THERE WAS NO OTHER DAMAGE OBSERVED ON ANY OTHER COMPONENTS. THE BIOMED REPORTED THAT THE MACHINE HAS BEEN RETURNED TO SERVICE WITHOUT ISSUE. THE SAMPLE WAS REPORTED TO BE UNAVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

  Patient problems: No Patient Involvement

  MAUDE report 10733116 ↗
• MalfunctionJul 21, 2020Thermal Decomposition of Device; Thermal Decomposition of Device

  A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO TECHNICAL SUPPORT THAT AN AUDIBLE ALARM AND A BURNING SMELL WAS COMING FROM A FRESENIUS 2008T HEMODIALYSIS (HD) MACHINE. THE BIOMED REQUESTED ONSITE SERVICE FROM A FRESENIUS FIELD SERVICE TECHNICIAN (FST). AN FST WENT ONSITE AND PERFORMED A MACHINE EVALUATION. THE FST REPORTED FINDING BURN DAMAGE DURING THE EVALUATION. THE BIOMED TOLD THE FST THAT THE ISSUE HAD OCCURRED DURING HEAT DISINFECT. DURING THE FST¿S INSPECTION, THEY DISCOVERED THAT THE DRIVER ON THE ACTUATOR BOARD (WHICH DRIVES THE FLOW MOTOR) DISPLAYED BURN DAMAGE. THERE WAS ALSO BURN DAMAGE ON THE BACK OF THE BOARD. ADDITIONALLY, BURN DAMAGE WAS FOUND ON THE FUNCTION BOARD AND ON ONE OF THE FUNCTION BOARD CABLES ¿ THE CABLE THAT RUNS FROM THE FUNCTION BOARD TO THE BLOOD PUMP. THE FST FIXED THE MACHINE BY REPLACING THE ACTUATOR BOARD, THE FUNCTION BOARD, AND THE FUNCTION BOARD CABLE. AS A PRECAUTION, THE FST ALSO REPLACED THE FLOW MOTOR. THERE WAS NO REPORTED SMOKE, MELTING, OR ARCING NOTED, AND THERE WERE NO REPORTS OF SPARKS OR FLAMES. NO DAMAGE WAS IDENTIFIED ON ANY OTHER COMPONENTS. THE MACHINE WAS PLUGGED INTO A HOSPITAL GRADE GROUND-FAULT CIRCUIT INTERRUPTE

  Patient problems: No Patient Involvement

  MAUDE report 10303279 ↗
• MalfunctionMay 7, 2020Thermal Decomposition of Device; Melted; Thermal Decomposition of Device; Melted

  A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED THAT A 2008T MACHINE HAD A BLANK DISPLAY AND WAS GIVING A CONSTANT AUDIBLE ALARM. IN ADDITION, THE MACHINE WOULD NO LONGER POWER ON. ADDITIONAL INFORMATION WAS PROVIDED DURING FOLLOW UP WITH THE BIOMED. THE BIOMED REMOVED THE PLUG FROM THE POWER OUTLET AND NOTICED THAT THE PLUG EXHIBITED SIGNS OF HEAT-RELATED DAMAGE. THE PLASTIC ON THE PLUG HAD MELTED AND DISCOLORATION WAS OBSERVED ON THE COMPONENT. PHOTOS OF THE PLUG WERE PROVIDED AND VERIFIED THE REPORTED DAMAGE. NO BURNING SMELL WAS NOTED. IN ADDITION, THERE WERE NO SIGNS OF SMOKE, SPARKS, OR FLAMES. NO DAMAGE WAS IDENTIFIED ON ANY OTHER COMPONENTS. THE BIOMED COULD NOT CONFIRM IF THE MACHINE WAS PLUGGED INTO A HOSPITAL GRADE GROUND-FAULT CIRCUIT INTERRUPTER (GFCI) OUTLET. HOWEVER, THE BIOMED DIDN¿T THINK THE MACHINE HAD A HISTORY OF FAILING THE ELECTRICAL LEAKAGE TEST. UPON FURTHER FOLLOW UP, THE BIOMED REPORTED THAT REPLACING THE POWER PLUG DID NOT RESOLVE THE ISSUE. ADDITIONAL TROUBLESHOOTING REVEALED THAT THE USER INTERFACE BOARD WAS LOOSE. THE BIOMED RESEATED THE BOARD AND WAS THEN ABLE TO POWER THE MACHINE ON. THE MACHINE SUBSEQUENTLY PASSED TESTING AND WAS READY TO B

  Patient problems: No Patient Involvement

  MAUDE report 10036762 ↗
• MalfunctionJan 14, 2020Thermal Decomposition of Device; Thermal Decomposition of Device

  A BIOMEDICAL TECHNICIAN (BIOMED) AT A USER FACILITY REPORTED THAT A FRESENIUS 2008T HEMODIALYSIS (HD) MACHINE HAD A BURNED POWER CORD. THE BURNED BOARD WAS NOTICED DURING TESTING WHEN THE MACHINE HAD LOW FLOW AND LOW CONDUCTIVITY ISSUES. 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 3514 HOURS AND THE POWER CORD WAS THE ORIGINAL FRESENIUS PART ON THE MACHINE. THE BIOMED REPORTED THAT THERE WAS NO DAMAGE OBSERVED ON ANY OTHER COMPONENTS, OR ANY OTHER ADDITIONAL ISSUES, ASSOCIATED WITH THE BURNED POWER CORD. THE BIOMED REPLACED THE POWER SUPPLY/POWER CORD, WHICH RESOLVED THE ISSUE. THE UNIT WAS RETURNED TO SERVICE AT THE USER FACILITY WITHOUT ISSUE AND WITHOUT REOCCURRENCE OF THE EVENT. THE POWER CORD WAS REPORTED TO BE RETURNED WITH THE FIELD SERVICE TECHNICIAN (FST).

  Patient problems: No Patient Involvement

  MAUDE report 9587597 ↗
• MalfunctionOct 28, 2019Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY NURSE REPORTED THAT A FRESENIUS 2008T MACHINE HAD BLOOD RISING TO THE P-VEN PORT DURING THE PATIENT¿S HEMODIALYSIS TREATMENT. THE MACHINE SOUNDED A VENOUS PRESSURE ALARM. THE VENOUS PRESSURE WAS CALIBRATED BUT CONTINUED TO DROP WHEN THEY TRIED TO PUMP. THE PATIENT WAS MOVED TO ANOTHER MACHINE AND DID NOT EXPERIENCE ANY ADVERSE EFFECTS AS A RESULT OF THIS INCIDENT. ADDITIONAL INFORMATION WAS REQUESTED, HOWEVER, TO DATE NOT PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9245064 ↗
• MalfunctionOct 21, 2019Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY NURSE REPORTED THAT A FRESENIUS 2008T MACHINE EXPERIENCED ISSUE. THE BLOOD WAS BACKING UP INTO THE VENOUS PORT WHILE THE PATIENT WAS ON THE MACHINE. THE PATIENT WAS MOVED TO ANOTHER MACHINE AND DID NOT EXPERIENCE ANY ADVERSE EFFECTS AS A RESULT OF THIS INCIDENT. ADDITIONAL INFORMATION WAS REQUESTED, HOWEVER, TO DATE NOT PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9213138 ↗
• MalfunctionOct 21, 2019Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED THAT A FRESENIUS 2008T MACHINE EXPERIENCED BLOOD BACKED UP TO THE TRANSDUCER PROTECTOR DURING PATIENT¿S HEMODIALYSIS TREATMENT. THE PATIENT WAS ABLE TO COMPLETE TREATMENT ON THE SAME MACHINE AND DID NOT EXPERIENCE ANY ADVERSE EFFECTS AS A RESULT OF THIS INCIDENT. ADDITIONAL INFORMATION WAS REQUESTED, HOWEVER, TO DATE NOT PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9213086 ↗