2008® Series Hemodialysis Machines 190858Recalls & reported problems

Summary

The FDA's MAUDE database contains 81 adverse event reports that list this exact device (DI 00840861100903), received between Jun 21, 2017 and Aug 26, 2026 — classified as 5 deaths, 1 injury, 75 malfunctions.

The most frequently reported specific device problem is “Thermal Decomposition of Device” (47 reports).

2 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-0029-2024 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 81 reports, in the reporter's own words as published by the FDA.

• DeathAug 26, 2026Adverse Event Without Identified Device or Use Problem

  On (b)(6) 2026 a biomedical technician requested onsite service for machine verification following a hemodialysis (HD) patient incident on the 2008T Hemodialysis machine. The patient coded and passed away on the machine. Attempts to obtain additional information were unsuccessful. The Fresenius Medical Care field service technician (FST) evaluated the machine. The FST performed the Ultrafiltration (UF) problem identification checklist according to P/N 507162 Rev. G, performed UF pump calibration, verified 1.0CC/ML, functional checks were performed, and the machine was heat disinfected. The machine passed all functional testing. No further information was provided.

  Patient problems: Cardiac Arrest

  MAUDE report 50451622 ↗
• MalfunctionAug 10, 2026Thermal Decomposition of Device

  A user facility's biomedical technician (BMT) reported that a 2008T Hemodialysis (HD) Machine displayed a flow error in standby mode. A Fresenius Field Service Technician (FST) was called onsite and found multiple valves were corroded and the valve connections were melted. The FST replaced the balancing chamber assembly to resolve the issues. Machine functional tests were completed and passed onsite after 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 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 50195897 ↗
• MalfunctionJun 9, 2026Thermal Decomposition of Device

  A BIOMEDICAL TECHNICIAN (BMT) REPORTED TO TECHNICAL SUPPORT THAT A 2008T MACHINE WAS EXPERIENCING A LOW FLOW ERROR UPON GOING INTO DIALYSIS MODE. THE BMT STATED WHEN HE TRIED TO CALIBRATE THE BALANCING CHAMBER NO FLOW TO DRAIN WAS OCCURRING. THERE WAS NO PATIENT INVOLVEMENT. TECHNICAL SUPPORT ADVISED THE BMT TO REPLACE THE DIAPHRAGM IN THE BALANCING CHAMBER. UPON FOLLOW UP, THE BMT REPLACED VALVE 34 BECAUSE IT HAD SHORTED OUT AND BURST. THE REPLACEMENT RESOLVED THE REPORTED ISSUE. THE MACHINE IS BACK IN SERVICE. THERE WAS NO PATIENT INVOLVED, NO HARM OR ADVERSE EVENTS REPORTED WITH THIS INCIDENT. THE BMT CLARIFIED THAT THE VALVE 34 WAS CHARRED AND CRACKED BUT THERE WAS NO SMOKE, BURNING SMELL, SPARK, FLAME OR ARCING NOTICED. THE MACHINE HAS NOT HAD ANY PAST PROBLEMS WITH FAILING THE ELECTRICAL LEAKAGE TEST AND NO OTHER COMPONENTS WERE DAMAGED. ADDITIONAL INFORMATION WAS REQUESTED, HOWEVER TO DATE HAS NOT BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25448849 ↗
• MalfunctionJan 13, 2026No Audible Alarm; Fluid/Blood Leak

  A USER FACILITY REPORTED THAT A DIALYZER BLOOD LEAK OCCURRED AT THE END OF THE PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE LEAK WAS VISUALLY OBSERVED ON THE OUTSIDE OF THE DIALYZER HOUSING AND IN THE HANSEN BLUE LINE. 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 UNKNOWN. 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 24058490 ↗
• MalfunctionJan 6, 2026Thermal Decomposition of Device

  A BIOMEDICAL TECHNICIAN (BMT) REPORTED TO TECHNICAL SUPPORT THAT A 2008T MACHINE DISPLAYED A ¿FLOW ERROR' MESSAGE IN DIALYSIS MODE WHILE BEING WORKED ON IN THE BMTS SHOP. 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. UPON FOLLOW UP, THE BMT SAID THAT VALVE 34 (V34) WAS BURNT AND BULGING. THE BMT STATED THERE WAS NO BURNING SMELL, SMOKE, SPARK, FLAME, ARCING, OR ANY OTHER VISIBLE HEAT OR ELECTRICAL DAMAGE RELATED TO THE BURNING AND BULGING OF V34. THE VALVE 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 MELTED VALVE. THE BMT REPLACED VALVE 34 TO RESOLVE THE ISSUE. THE MACHINE WAS RETURNED TO SERVICE AT THE USER FACILITY WITHOUT ISSUE AND WITHOUT RECURRENCE OF THE EVENT. THE COMPLAINT DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23975388 ↗
• MalfunctionDec 27, 2024Thermal Decomposition of Device; Melted; Thermal Decomposition of Device; Melted

  THE BIOMEDICAL TECHNICIAN (BIOMED) FOR A USER FACILITY REPORTED TO FRESENIUS TECHNICAL SERVICES THAT THERMAL DECOMPOSITION WAS DISCOVERED WITHIN THE 2008T MACHINE. THE BIOMED STATED THE 2008T MACHINE WAS INITIALLY REMOVED FROM SERVICE FOR LEAKING. THE BIOMED COULD NOT CONFIRM WHETHER THE MACHINE LEAKED DURING PATIENT TREATMENT BUT CONFIRMED THAT THERE WAS NO PATIENT ADVERSE EVENT, SERIOUS INJURY, OR REQUIRED MEDICAL INTERVENTION REPORTED WITH THIS ISSUE. AN EVALUATION WAS PERFORMED AND A BROKEN ULTRAFILTRATION (UF) CHECK VALVE WAS DETERMINED TO BE THE CAUSE OF THE REPORTED LEAK. THE BIOMED ALSO NOTED THERMAL DECOMPOSITION ON THE FLOW MOTOR. THE BIOMED EXPLAINED THAT THE UF CHECK VALVE LEAKED ONTO THE FLOW MOTOR AND CAUSED IT TO OVERHEAT. THE UF CHECK VALVE AND THE FLOW MOTOR WERE REPLACED. THE BIOMED RAN FUNCTIONAL TESTING AND NOTED AN ¿ELECTRICAL BURN¿ SMELL. THE MACHINE WAS POWERED OFF. UPON FURTHER INSPECTION, THE BIOMED NOTED THE TOP OF VALVE 33 HAD MELTED. THERE WAS NO OBSERVED SMOKE, SPARK, FLAME, OR ARCING. NO SMOKE DETECTOR WAS TRIGGERED AND USE OF A FIRE EXTINGUISHER WAS NOT REQUIRED. VALVE 33 WAS REPLACED TO RESOLVE THIS ISSUE. THE MACHINE WAS RETURNED TO SERVICE FOLLOWIN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21028539 ↗
• DeathDec 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 10/DEC/2024 FRESENIUS WAS NOTIFIED THAT A PATIENT PASSED AWAY WHILE UTILIZING THE 2008T MACHINE FOR HEMODIALYSIS (HD) TREATMENT. A REQUEST FOR MACHINE AND DISPOSABLE EVALUATION WAS MADE. A FIELD SERVICE TECHNICIAN (FST) WAS REQUESTED TO PERFORM AN INSPECTION OF THE MACHINE. INSPECTION COMPLETED, AN ADVERSE EVENT PRE-SERVICE EVALUATION CHECKLIST AND ULTRAFILTRATION (UF) PROBLEM IDENTIFICATION CHECKLIST WAS PERFORMED. A SMALL LEAK WAS OBSERVED ON THE BOTTOM OF THE AIR SEPARATOR. THE FAILURE ON THE ALARM TEST WAS THE 9 VOLT BATTERY.

  Patient problems: Insufficient Information; Loss of consciousness; Low Blood Pressure/ Hypotension

  MAUDE report 20992427 ↗
• MalfunctionOct 11, 2024Thermal Decomposition of Device; Thermal Decomposition of Device

  A USER FACILITY'S BIOMEDICAL TECHNICIAN (BMT) REPORTED TO TECHNICAL SERVICES THAT A 2008T HEMODIALYSIS (HD) MACHINE HAD A BROKEN ULTRAFILTRATION (UF) CHECK VALVE, WHICH CAUSED A FLUID LEAK. UPON FOLLOW UP, THE BMT SAID THAT THE MOTOR INTERNALS WERE BURNED. 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. IT IS UNKNOWN IF ANY OF THE BURNT COMPONENTS ARE AVAILABLE FOR MANUFACTURER 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. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE FILE WILL BE UPDATED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20427565 ↗
• MalfunctionJul 10, 2024Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS TECHNICAL SERVICES THAT THE 2008T MACHINE REBOOTED DURING THE PATIENT'S HEMODIALYSIS (HD) TREATMENT. THE MACHINE CONTINUALLY POWERED DOWN AND POWERED BACK ON WITHOUT REACHING THE SELECT PROGRAM SCREEN. ADDITIONAL INFORMATION WAS OBTAINED DURING FOLLOW-UP WITH THE BIOMED AND A USER FACILITY REGISTERED NURSE (RN). THE REPORTED ISSUE OCCURRED WITHIN THE FIRST MINUTE OF THE PATIENT'S HEMODIALYSIS (HD) TREATMENT. BLOOD LOSS RESULTED FROM THE REPORTED ISSUE. THE PATIENT'S BLOOD WAS RETURNED MANUALLY VIA HAND CRANK TO MINIMIZE THE BLOOD LOSS. THE PATIENT'S ESTIMATED BLOOD LOSS (EBL) WAS NOT PROVIDED. THERE WAS NO SERIOUS INJURY OR REQUIRED MEDICAL INTERVENTION THAT RESULTED FROM THE REPORTED ISSUE. TREATMENT WAS RESTARTED ON A DIFFERENT MACHINE AND COMPLETED SUCCESSFULLY. THE MACHINE WAS PULLED FROM SERVICE FOLLOWING THE REPORTED EVENT. THE BUTTON PAD ON THE FRONT OF THE MACHINE WAS REPLACED TO RESOLVE THE REPORTED ISSUE. THE MACHINE WAS RETURNED TO SERVICE WITHOUT FURTHER ISSUE. NO PARTS WERE REPORTED TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19714844 ↗
• MalfunctionJan 24, 2024Thermal Decomposition of Device; Thermal Decomposition of Device

  A BIOMEDICAL TECHNICIAN REPORTED AN OUT OF BOX FAILURE FOR A FUNCTION BOARD. THE FUNCTION BOARD WAS INSTALLED AND THERE WAS A LOW FLOW ERROR MESSAGE WITH AN AUDIBLE ALARM. THE TECHNICIAN FOUND THE FUNCTION BOARD EEPROM BURNT. ANOTHER BOARD WAS ORDERED. IN A FOLLOW UP, THE TECHNICIAN VERIFIED THERE WAS NO PATIENT INVOLVED, THEREFORE NO HARM. A NEW FUNCTION BOARD HAS BEEN INSTALLED AND THE 2008T MACHINE IS BACK IN SERVICE. THE BURNT BOARD IS BEING RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18575143 ↗
• MalfunctionDec 26, 2023Thermal Decomposition of Device; Melted; Thermal Decomposition of Device; Melted

  A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS TECHNICAL SERVICES THAT THERMAL DECOMPOSITION WAS IDENTIFIED ON THE POWER SUPPLY OF THE 2008T MACHINE. THE REPORTED DAMAGE WAS DISCOVERED DURING TROUBLESHOOTING AFTER THE MACHINE WAS PULLED FOR EVALUATION FOR FAILING TO POWER ON. WIRES CONNECTED TO THE POWER SUPPLY WERE DARK AND DISCOLORED. YELLOW RESISTORS ON THE CAPACITORS WERE BURNED. THERE WAS ALSO EVIDENCE OF MELTING. THERE WAS NO OBSERVED BURNING SMELL, SMOKE, SPARK, FLAME, ARCING, OR ANY OTHER VISIBLE HEAT OR ELECTRICAL DAMAGE RELATED TO THE THERMAL DAMAGE ON THE POWER SUPPLY. THE MACHINE HAS APPROXIMATELY 21,000 OPERATING HOURS. IT COULD NOT BE CONFIRMED WHETHER PARTS WERE ORIGINAL TO THE MACHINE. THE BIOMED REPLACED THE POWER SUPPLY ASSEMBLY, POWER LOGIC BOARD, MOTHERBOARD, AND FRONT PANEL KEYPAD (TWICE). THE BIOMED STATED THERE WAS POWER TO THE MACHINE BUT THE SCREEN REMAINED BLANK, THE MACHINE CONTINUOUSLY ALARMED AND THEN SHUT DOWN AGAIN AFTER A FEW MINUTES. THE BIOMED STATED UPON FOLLOW-UP THAT THE MACHINE REMAINS OUT OF SERVICE PENDING REPAIR. THERE WAS NO PATIENT INVOLVEMENT NOR PERSONAL HARM TO ANY PATIENTS OR INDIVIDUALS AS A RESULT OF THE REPORTE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18393092 ↗
• MalfunctionMar 30, 2023Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS TECHNICAL SERVICES THAT A 2008T MACHINE DID NOT DETECT A BLOOD LEAK THAT OCCURRED DURING A PATIENT'S HEMODIALYSIS (HD) TREATMENT WITH A BRAUN REVACLEAR (NON-FRESENIUS) DIALYZER. ADDITIONAL INFORMATION WAS PROVIDED DURING FOLLOW-UP BY THE CLINICAL COORDINATOR. THE BLOOD LEAK WAS VISUALLY OBSERVED BY THE FACILITY STAFF APPROXIMATELY 20 MINUTES PRIOR TO THE COMPLETION OF HEMODIALYSIS (HD) TREATMENT. THE BLOOD LEAK WAS CONFIRMED TO BE INTERNAL. THE STAFF MAINTAINS THAT THE MACHINE NEVER ALARMED TO INDICATE THAT A BLOOD LEAK HAD OCCURRED. THE PATIENT DID NOT EXPERIENCE A SERIOUS INJURY OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THE REPORTED ISSUE. TREATMENT ENDED APPROXIMATELY 20 MINUTES EARLY. THE PATIENT'S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 180 ML. A FRESENIUS FIELD SERVICE TECHNICIAN (FST) WAS CALLED ONSITE TO EVALUATE THE MACHINE. A SIMULATED TREATMENT WAS PERFORMED AND THE THE MACHINE PROVIDED A BLOOD LEAK ALARM WITHOUT ISSUE. THE CALIBRATION OF THE BLOOD LEAK DETECTOR WAS VERIFIED TO BE WITHIN RANGE. NO PARTS WERE REPLACED. THE BLOOD LEAK DETECTOR WAS DETERMINED TO BE OPERATING AS EXPECTED AS THE RE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16648645 ↗
• MalfunctionNov 22, 2022Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED AN E.23 ALARM THAT OCCURRED AT THE BEGINNING OF A PATIENT¿S HEMODIALYSIS (HD) TREATMENT ON A FRESENIUS 2008T MACHINE. THE STAFF WAS UNABLE TO CLEAR THE ALARM AND THE PATIENT¿S BLOOD COULD NOT BE RETURNED. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS 300 ML. 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 WAS MOVED TO A DIFFERENT MACHINE WHERE THEY COMPLETED TREATMENT AFTER BEING RE-SETUP WITH NEW SUPPLIES. TO RESOLVE THE REPORTED MACHINE ISSUE, THE BLOOD PUMP MOTOR WAS REPLACED. THE BIOMED STATED THERE WERE NO ISSUES WITH THE DISPOSABLE SUPPLIES THAT WERE IN USE AT THE TIME OF THE EVENT. A SAMPLE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15848351 ↗
• MalfunctionNov 16, 2022Thermal Decomposition of Device; Thermal Decomposition of Device

  A FRESENIUS FIELD SERVICE TECHNICIAN (FST) REPORTED THAT A FRESENIUS 2008T HEMODIALYSIS (HD) MACHINE HAD A BURNT POWER PLUG. THE FST REPORTED THAT THE POWER PLUG APPEARED TO BE BLACK AND DISCOLORED. THE REPORTED ISSUE WAS FOUND DURING MACHINE REPAIR AFTER THE FST WAS CALLED ONSITE BY A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) TO ADDRESS ISSUES WITH LOW CONDUCTIVITY AND A BLANK HOUR METER. 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 FST REPORTED THAT THERE WAS NO MELTING, BURNING SMELL, SMOKE, SPARK, FLAME, OR ARCING OBSERVED. THE FST REPORTED THAT THERE WAS NO DAMAGE OBSERVED ON ANY OTHER COMPONENTS. THE FST REPLACED THE POWER PLUG TO RESOLVE THIS ISSUE IN ADDITION TO REPLACING SPRINGS WITHIN THE ACID PUMP AND THE HOUR METER TO RESOLVE THE INITIALLY REPORTED ISSUES. THE FST STATED THAT THE MACHINE HOURS ARE NOT AVAILABLE AS A RESULT OF REPLACING THE MACHINE'S HOUR METER. THE FST REPORTED THAT THE MACHINE HAS BEEN RETURNED TO SERVICE WITHOUT ISSUE. THE POWER PLUG WAS REPORTED TO BE DISCARDED AND UNAVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15808561 ↗
• MalfunctionOct 24, 2022Thermal Decomposition of Device; Thermal Decomposition of Device

  A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS TECHNICAL SUPPORT (TS) THAT THE HEPARIN PUMP ON A 2008T HEMODIALYSIS (HD) MACHINE WAS NOT WORKING. THE MACHINE WAS BEING PREPPED FOR A TREATMENT WHEN THE FACILITY NOTICED THIS; THERE WAS NO PATIENT INVOLVEMENT. THE BIOMED COULD NOT RESOLVE THE ISSUE AND CONTACTED FRESENIUS TS FOR FURTHER ASSISTANCE. A FRESENIUS FIELD SERVICE TECHNICIAN (FST) WAS SUBSEQUENTLY DISPATCHED TO THE USER FACILITY TO PROVIDE FURTHER SUPPORT. DURING TESTING, IT WAS FOUND THAT IC21 ON THE ACTUATOR TEST BOARD WAS BLACKENED (OR BURNT). IT WAS CONFIRMED THAT THERE WAS NO BURNING SMELL, AND THERE WERE NO SIGNS OF ANY SMOKE, SPARKS, OR FLAMES. THE MACHINE HAD 1266 HOURS ON IT AT THE TIME OF THE REPAIR. THE FST DID NOT KNOW IF THE MACHINE HAD EVER FAILED THE ELECTRICAL LEAKAGE TEST. IT WAS CONFIRMED THAT THE MACHINE WAS PLUGGED INTO A HOSPITAL GRADE GROUND-FAULT CIRCUIT INTERRUPTER (GFCI). OTHER THAN THE DAMAGED CHIP, NO OTHER COMPONENTS WERE FOUND TO BE DAMAGED. TO RESOLVE THE REPORTED ISSUE, THE ACTUATOR TEST BOARD AND THE HEPARIN PUMP WERE BOTH REPLACED. THE BIOMED FROM THE FACILITY HAD A SPARE HEPARIN PUMP THAT WAS USED TO REPLACE THE BAD ONE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15663935 ↗
• MalfunctionJul 8, 2022Thermal Decomposition of Device; Sparking; Thermal Decomposition of Device; Sparking

  A BIOMEDICAL TECHNICIAN (BIOMED) AT A USER FACILITY REPORTED THAT A FRESENIUS 2008T MACHINE TRIPPED THE GROUND-FAULT CIRCUIT INTERRUPTER (GFCI) POWER OUTLET AND A SPARK COULD BE SEEN FROM THE POWER PLUG. BLOWN FUSES WERE ALSO IDENTIFIED ON THE POWER SUPPLY AFTER THE MACHINE WAS PULLED FROM SERVICE FOR EVALUATION AFTER FAILING TO POWER ON. 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. NO PARTS WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14957759 ↗
• MalfunctionJun 29, 2022Melted; Melted

  A FRESENIUS FST (FIELD SERVICE TECHNICIAN) WAS CALLED ONSITE BY A USER FACILITY TO REPAIR A 2008T MACHINE THAT HAD A BLUE HANSEN HOSE LEAK DURING HEAT DISINFECT. THE FST TRIMMED BACK THE HOSES GOING IN AND OUT OF THE SAMPLE PORT AND RAN THE MACHINE THROUGH A HEAT DISINFECT AND THE LEAKS STOPPED. WHEN THE MACHINE WAS PLUGGED BACK IN A MELTED POWER PLUG WAS OBSERVED AND WAS REPLACED. THE MACHINE WAS TESTED AND PLACED BACK IN SERVICE. UPON FOLLOW-UP, THE BIOMEDICAL TECHNICIAN (BMT) CONFIRMED ALL ISSUES HAVE BEEN RESOLVED AND THE MACHINE HAS BEEN RETURNED TO SERVICE. MACHINE FUNCTIONAL TESTS WERE COMPLETED AND PASSED ONSITE AFTER REPAIR. THERE WAS NO PATIENT INVOLVEMENT OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14853013 ↗
• MalfunctionJun 10, 2022Melted; Melted

  A USER FACILITY BIOMEDICAL TECHNICIAN (BMT) REPORTED TO TECHNICAL SUPPORT THAT A 2008T MACHINE DISPLAYED THE FLOW INLET ERROR MESSAGE AND HAD A BURNING SMELL DURING HEAT DISINFECT MODE. HE FOUND THAT PLASTIC AROUND THE DEAERATION MOTOR BRUSHES MELTED. HE RECENTLY INSTALLED THE DEAERATION MOTOR AND RAN WITHOUT ISSUE FOR MULTIPLE TREATMENTS. THERE WAS NO PATIENT INVOLVEMENT, PATIENT HARM, OR ADVERSE EVENT REPORTED. THE BIOMEDICAL TECHNICIAN STATED THE MACHINE REMAINS OUT OF SERVICE PENDING DECISION FROM THE CLINIC MANAGER. THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT. THE MACHINE WAS PLUGGED INTO A HOSPITAL GRADE GROUND-FAULT CIRCUIT INTERRUPTER (GFCI) OUTLET AND DOES NOT HAVE A PREVIOUS HISTORY OF FAILING AN ELECTRICAL LEAKAGE TEST. IT WAS REPORTED THE REPLACED DEAERATION MOTOR COMPONENT WAS RETURNED FOR INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14658198 ↗
• MalfunctionMar 17, 2022Display or Visual Feedback Problem

  WHEN THE PATIENT WAS CONNECTED TO THE HEMODIALYSIS MACHINE THE MACHINE WAS ALARMING HIGH CONDUCTIVITY, NOT READING TRANSMEMBRANE PRESSURE (TMP), AND SAID LOW FLOW ERROR. THERE WAS AN ATTEMPT TO RESET THE MACHINE, BUT DUE TO HIGH PRESSURES THAT WERE NOT READING AND NO TMP READING THE PATIENT'S VENOUS SITE ON THE LEFT AV FISTULA INFILTRATED.

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

  MAUDE report 13794847 ↗
• MalfunctionNov 4, 2021Inadequate Ultra Filtration; Inadequate Ultra Filtration

  A USER FACILITY HEMODIALYSIS (HD) NURSE REPORTED THAT THE ULTRAFILTRATION (UF) STARTED BUT THE CLOCKS ARE NOT COUNTING DOWN. THE NURSE REPORTED THAT THE MACHINE IS SETUP FOR A PEDIATRIC PATIENT WITH THE GOALS AND TIMES SET. THE PATIENT WAS CONNECTED TO THE MACHINE AND THE "TREATMENT START" BUTTON WAS PRESSED WHICH BEGAN TREATMENT AND CAUSED THE UF BUTTON TO GO GREEN. HOWEVER BOTH TREATMENT TIME AND UF TIME CLOCKS DID NOT START COUNTING DOWN. TECHNICAL SUPPORT HAD THE NURSE STOP TREATMENT USING THE "TREATMENT PAUSE" BUTTON. TREATMENT WAS RESTARTED BUT THE UF COUNTED UP WHILE BOTH TREATMENT TIME AND UF CLOCKS REMAINED AT TIME SET. THE NURSE STATED THERE WAS NO WAY TO TELL WHEN TREATMENT STARTED BUT THE ULTRAFILTRATION (UF) WAS STILL PROGRESSING. THE NURSE CONFIRMED THAT THERE WERE NO ADJUSTMENTS MADE TO THE PATIENT'S UF GOAL, RATE, OR TIME. TECHNICAL SUPPORT RECOMMENDED REMOVING THE PATIENT FROM THE MACHINE AND REMOVING THE MACHINE FROM SERVICE UNTIL A FULL EVALUATION IS PERFORMED TO DETERMINE THE CAUSE OF THE CLOCK ERRORS. THE UF WAS NOT TURNED OFF AT ALL DURING TREATMENT. IT IS UNKNOWN IF THE UP/DOWN ARROW KEYS WERE USED TO PROGRAM THE INITIAL SETTING. THE PATIENT WAS ABLE TO SUCCE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12752893 ↗
• MalfunctionOct 13, 2021Thermal Decomposition of Device; Thermal Decomposition of Device

  A USER FACILITY BIOMEDICAL TECHNICIAN (BMT) REPORTED TO TECHNICAL SUPPORT THAT A 2008T MACHINE DISPLAYED THE ACID PUMP ALWAYS EOS MESSAGE. THE CUSTOMER HAD SWAPPED THE ACID AND BIC PUMP CONNECTORS ON THE DISTRIBUTION BOARD AND THE MESSAGE DID NOT CHANGE. THERE WAS A SLIGHT BURN SMELL, THE CUSTOMER DID NOT NOTICE ANY BURN MARKS ON THE BOARD. UPON FOLLOW UP, THE CUSTOMER SAID THAT THE ACTUATOR BOARD WAS "FRIED". IT HAD VISIBLE SIGNS OF HEAT DAMAGE. THERE WAS SMOKE, CHARRING, AND CRACKS ON THE BOARD. THERE WERE NO VISIBLE FLAMES. NO PATIENTS WERE INVOLVED. PHOTOS ARE AVAILABLE AND HAVE BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12623496 ↗
• MalfunctionJul 13, 2021Thermal Decomposition of Device; Thermal Decomposition of Device

  A BIOMEDICAL TECHNICIAN (BMT) AT A USER FACILITY REPORTED A FRESENIUS 2008T HEMODIALYSIS (HD) MACHINE HAD A BLANK DISPLAY. THE AUDIBLE ALARMS OPERATED NORMALLY. THE BMT REPORTED THERE WAS NO SMOKE, SPARK, OR FLAME OBSERVED. THE INVERTER BOARD ON THE DISPLAY ASSEMBLY APPEARED FRIED. IT WAS NOTED THE COMPONENT LOOKED LIKE IT HAD GOTTEN WET. THE ISSUE WAS NOTICED DURING POWER UP OF THE MACHINE. UPON FOLLOW-UP, THE BMT CONFIRMED THE DISPLAY ASSEMBLY APPEARED BURNT. 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 25,000 HOURS AND THE DISPLAY ASSEMBLY BOARD WAS THE ORIGINAL FRESENIUS PART ON THE MACHINE. PER BMT THE DISPLAY ASSEMBLY WAS REPLACED. THE BMT REPORTED THE UNIT WAS RETURNED TO SERVICE AT THE USER FACILITY WITHOUT REOCCURRENCE OF THE EVENT. THE BMT REPORTED THAT THE DISPLAY ASSEMBLY COMPONENT WAS AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12160363 ↗
• MalfunctionJun 23, 2021Thermal Decomposition of Device; Thermal Decomposition of Device

  A USER FACILITY BIOMEDICAL TECHNICIAN (BMT) REPORTED THAT A FRESENIUS 2008T HEMODIALYSIS (HD) MACHINE WAS EXPERIENCING LOW CONDUCTIVITY. THE BMT STATED HE NOTICED THE CABLE ON THE ACID PUMP WAS BURNED. THE BMT WAS ISSUED A REPLACEMENT ACID PUMP. IT IS UNKNOWN IF THE ACID CABLE WAS AVAILABLE TO BE RETURNED FOR MANUFACTURER EVALUATION. THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT. ADDITIONAL INFORMATION WAS REQUESTED, HOWEVER TO DATE HAS NOT BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12053256 ↗
• MalfunctionJun 23, 2021Thermal Decomposition of Device; Thermal Decomposition of Device

  A USER FACILITY BIOMEDICAL TECHNICIAN (BMT) REPORTED THAT A FRESENIUS 2008T HEMODIALYSIS (HD) MACHINE WAS EXPERIENCING A LOW CONDUCTIVITY MESSAGE. IT IS UNKNOWN IF THE MACHINE PROMPTED WITH AUDIBLE ALARMS. THE COND WAS 10.0 MS/CM. THE BMT STATED HE NOTICED THE CABLES ON THE ACID PUMP AND BIC PUMP WERE BURNED. THE BMT WAS ISSUED A REPLACEMENT ACID PUMP. IT IS UNKNOWN IF THE ACID OR BIC PUMP CABLES WERE AVAILABLE TO BE RETURNED FOR MANUFACTURER EVALUATION. THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT. ADDITIONAL INFORMATION WAS REQUESTED, HOWEVER TO DATE HAS NOT BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12053201 ↗
• MalfunctionJun 13, 2021Thermal Decomposition of Device; Thermal Decomposition of Device

  A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED THAT A FRESENIUS 2008T HEMODIALYSIS (HD) MACHINE WAS EXPERIENCING LOW CONDUCTIVITY. THE BIOMED COULD NOT GET THE CONDUCTIVITY TO GO UP. DURING TROUBLESHOOTING, THE BIOMED FOUND THAT THE ACID PUMP DISPLAYED THERMAL DAMAGE IN THE FORM OF VISIBLE BURN MARKS. SPECIFICALLY, THE BIOMED STATED THERE WERE BLACK SPOTS ON THE RIBBON CABLE. IN ADDITION, THERE WAS BURN DAMAGE FOUND ON THE HEATER ROD. TO RESOLVE THE REPORTED ISSUE, THE BIOMED REPLACED THE ACID PUMP AND THE HEATER ROD. THERE WAS NO BURNING SMELL, SMOKING, 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 INTERRUPTER (GFCI) OUTLET AND HAD PREVIOUS HISTORY OF FAILING THE ELECTRICAL LEAKAGE TEST. THE BIOMED STATED THERE WERE 1,892 HOURS ON THE MACHINE. AFTER REPLACING THE DAMAGED PARTS, THE BIOMED SATED THE MACHINE WAS RETURNED TO SERVICE. THE ACID PUMP WAS SAID TO BE AVAILABLE FOR MANUFACTURER EVALUATION. THE BIOMED STATED THEY WOULD CONTACT TECHNICAL SERVICE TO SET UP A RETURNED GOODS AUTHORIZATION (RGA) FOR FAILURE ANALYSIS OF THE PART. THERE WA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11989241 ↗