2008T BlueStar Hemodialysis Machine 191128Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00840861102105), received between Aug 4, 2020 and Apr 29, 2026 — classified as 5 deaths, 1 injury, 16 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (6 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. Apr 17, 2024Class IIOpen, Classified

   An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.

   Z-1869-2024 · Root cause: Device Design · Recall details · FDA record ↗

3. Sep 6, 2023Class IOpen, Classified

   Potential PCBA leaching from tubing of hemodialysis machines.

   Z-0034-2024 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 29, 2026Thermal Decomposition of Device

  A BIOMEDICAL TECHNICIAN (BMT) REPORTED TO TECHNICAL SUPPORT THAT A 2008T MACHINE DISPLAYED A 24 V LOW MESSAGE. UPON FOLLOW UP, THE BMT STATED THAT THE POWER SUPPLY WAS REPLACED TO RESOLVED THE REPORTED ISSUE. THE MACHINE WAS RETURNED TO SERVICE. IT WAS CONFIRMED THAT THERE WAS NO PATIENT INVOLVEMENT, NO HARM OR ADVERSE EVENTS WITH THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25034773 ↗
• MalfunctionAug 20, 2025Thermal Decomposition of Device; Thermal Decomposition of Device

  A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) CONTACTED FRESENIUS TECHNICAL SUPPORT BECAUSE A CRIT-LINE DEVICE WAS NOT PASSING THE VERIFICATION TEST ON A 2008T HEMODIALYSIS MACHINE. THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE EVENT. THE BIOMED WAS REQUESTING ASSISTANCE TO HAVE THE DEVICE VERIFIED. A FRESENIUS FIELD SERVICE TECHNICIAN (FST) WAS DISPATCHED TO THE FACILITY TO EVALUATE THE MACHINE. THE FST CONFIRMED THE CRIT-LINE DEVICE WOULD NOT PASS THE VERIFICATION TEST. THE FST TRIED THE CRIT-LINE DEVICE ON OTHER KNOWN GOOD MACHINES, AND IT WOULD NOT PASS THE TEST ON THOSE MACHINES EITHER. DURING EVALUATION OF THE ORIGINAL MACHINE IN QUESTION, THE FST FOUND A BURNT DIODE ON THE FUNCTIONAL BOARD. THE FST SAID THIS DIODE CONTROLS THE FRONT USB PORT BOARD. NO OTHER COMPONENTS WERE FOUND TO BE DAMAGED. TO RESOLVE THE REPORTED ISSUE, THE BIOMED REPLACED THE USB PORT BOARD AND THE FUNCTIONAL BOARD. THERE WAS NO BURNING SMELL, AND THERE WERE NO SIGNS OF ANY SMOKE, SPARKS, OR FLAMES. 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. AT THE TIME OF THE REPAIR, THE MACHINE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22856382 ↗
• MalfunctionMay 15, 2025Fluid/Blood Leak; Fluid/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 TWO HOURS AFTER THE INITIATION OF A PATIENT'S HD TREATMENT RESULTING IN BLOOD LOSS. THE MACHINE, A FRESENIUS 2008T MACHINE, ALARMED APPROPRIATELY WITH AN AIR IN LINE ALARM. FRESENIUS BLOODLINES WERE NOT IN USE. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 1ML. THERE WAS NO PATIENT SERIOUS INJURY OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THIS EVENT. THE PATIENT WAS RESTARTED ON A NEW MACHINE AND TREATMENT COMPLETED SUCCESSFULLY WITH NEW SUPPLIES. PER THE BMT, THE MACHINE WAS RETURNED TO SERVICE AFTER THEY 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 22027581 ↗
• MalfunctionApr 2, 2025Thermal Decomposition of Device; Thermal Decomposition of Device

  A USER FACILITY'S BIOMEDICAL TECHNICIAN (BMT) REPORTED THAT A 2008T HEMODIALYSIS (HD) MACHINE POWERED DOWN BY ITSELF DURING SET UP. DURING REPAIR, THE BMT NOTED THAT THE CAPACITOR ON THE MOTHERBOARD WAS CHARRED. 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. 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 21752450 ↗
• MalfunctionJul 18, 2024Fluid/Blood Leak; Fluid/Blood Leak

  A FRESENIUS FIELD SERVICE TECHNICIAN (FST) WAS CALLED ONSITE AFTER THE BLOOD PUMP OF A 2008T MACHINE TORE THE TUBING OF THE B.BRAUN BLOODLINES (NOT A FRESENIUS PRODUCT) DURING THE PATIENT'S HEMODIALYSIS (HD) TREATMENT. A USER FACILITY NURSE CONFIRMED THE REPORTED EVENT DURING FOLLOW-UP BUT DECLINED TO PROVIDE MUCH OF THE ADDITIONAL INFORMATION THAT WAS REQUESTED REGARDING THE TREATMENT. IT WAS CONFIRMED THAT THE PATIENT DID NOT EXPERIENCE A SERIOUS INJURY OR REQUIRE MEDICAL INTERVENTION. THE PATIENT'S ESTIMATED BLOOD LOSS (EBL) WAS NOT PROVIDED. THE FST REPLACED THE BLOOD PUMP MODULE TO RESOLVE THE REPORTED ISSUE. THE MACHINE PASSED FUNCTIONAL TESTING AND WAS RETURNED TO THE CUSTOMER. THE SAMPLE IS AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19772404 ↗
• DeathJan 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A BIOMEDICAL TECHNICIAN CONTACTED FRESENIUS TECHNICAL SUPPORT TO REQUEST AN INSPECTION OF THE 2008T HEMODIALYSIS (HD) MACHINE AFTER A HOSPITAL PATIENT PASSED AWAY DURING DIALYSIS TREATMENT. THE PATIENT¿S DOCTOR HAD ORDERED HD AS THE PATIENT WAS IN VERY BAD HEALTH (UNSPECIFIED). AT THE LAST MINUTE OF TREATMENT, THE PATIENT FLATLINED AND PASSED AWAY. THERE WERE NO ISSUES DURING THE DIALYSIS TREATMENT (NO ALARMS OR MACHINE ISSUES). THERE WERE NO REPORTED PATIENT COMPLAINTS OR PROBLEMS. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE UNSUCCESSFUL.

  Patient problems: Insufficient Information

  MAUDE report 18519412 ↗
• MalfunctionJan 8, 2024Inadequate Ultra Filtration; Inadequate Ultra Filtration

  A USER FACILITY REGISTERED NURSE (RN) REPORTED UPON COMPLETION OF A PATIENT'S HEMODIALYSIS (HD) TREATMENT THE MACHINE NOTED WITH AN ULTRAFILTRATION (UF) RATE AT 70ML AND THE UF REMOVED AT 228 ML. A FIELD SERVICE TECHNICIAN (FST) COMPLETED A UF PROBLEM IDENTIFICATION CHECKLIST AND COULD NOT DUPLICATE THE SYMPTOM. A SIMULATED ONE HOUR TREATMENT WAS PERFORMED WITH A 1000 ML GOAL. 995ML WAS REMOVED AT END OF THE TREATMENT CLOCK WHEN THE TEST COMPLETED. UPON FOLLOW-UP, THE RN CONFIRMED THE REPORTED EVENT AND STATED THE PATIENT HAD AN INADEQUATE UF REMOVAL DURING THEIR HEMODIALYSIS TREATMENT. IT WAS UNKNOWN WHAT MAY HAVE ATTRIBUTED TO THE REPORTED ISSUE. THE RN STATED THE MACHINE HAD BEEN PULLED FROM SERVICE AND WAS EVALUATED BY THE FST, WHO WAS UNABLE TO DUPLICATE THE SYMPTOM. PER RN THE PATIENT DID NOT REQUIRE ANY MEDICAL INTERVENTION AS A RESULT OF THE REPORTED ISSUE AND REMAINED ASYMPTOMATIC. IT WAS DECIDED BY THE NEPHROLOGIST AND AGREED BY THE PATIENT TO RETURN TO THE CLINIC THE FOLLOWING DAY FOR ADDITIONAL HD TREATMENT, WHICH WAS COMPLETED WITHOUT ISSUE. THE RN CONFIRMED THE PATIENT HAD SINCE BEEN ABLE TO CONTINUE IN-CENTER HD THERAPY WITHOUT FURTHER ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18470302 ↗
• MalfunctionAug 15, 2023Thermal Decomposition of Device; Thermal Decomposition of Device

  A USER FACILITY REPORTED NO POWER TO CLIC CRIT-LINE CLIP . IT WAS DISCOVERED THE STAFF WAS GETTING THE USB PORT WET AND SHORTING OUT THE USB AND THE USB CONNECTION ON THE FUNCTION BOARD. BOTH COMPONENTS WERE REPLACED AND VERIFIED OPERATION OF THE MACHINE. UPON FOLLOW-UP, THE BIOMEDICAL TECHNICIAN (BMT) REPORTED STATED THE THERE WERE NO DIAGNOSTIC MESSAGES OR AUDIBLE ALARMS. THE BMT STATED THERE WAS NO PATIENT INVOLVEMENT, PATIENT HARM, OR ADVERSE EVENT REPORTED. THE BMT STATED THE FUNCTION BOARD APPEARED BURNT AND CONFIRMED THERE WAS NO SMOKE, FIRE OR BURNING SMELL AS ASSOCIATED WITH THE REPORTED EVENT. THE BMT REPLACED THE FUNCTION BOARD AND USB CONNECTION TO RESOLVE THE REPORTED ISSUE. 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. THE REPLACED COMPONENTS WERE AVAILABLE TO BE RETURNED FOR INVESTIGATION. A PHOTO WAS PROVIDED FOR THE INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17552144 ↗
• MalfunctionAug 14, 2023Fluid/Blood Leak; Fluid/Blood Leak

  A FRESENIUS FIELD SERVICE TECHNICIAN (FST) REPORTED THAT THE BLOOD PUMP ROTOR COVER ON THE 2008T MACHINE WAS CRACKED AND TORE THROUGH THE FRESENIUS COMBI SET BLOODLINES DURING A PATIENT¿S HEMODIALYSIS (HD) TREATMENT, CAUSING A BLOOD LEAK TO OCCUR. UPON FOLLOW UP WITH THE USER FACILITY REGISTERED NURSE (RN), IT WAS CONFIRMED THAT THE EVENT OCCURRED DURING THE PATIENT¿S TREATMENT AND THE MACHINE DID PROVIDE AIR DETECTED ALARMS TO ALERT THE STAFF TO THE ISSUE. THE RN STATED THAT THE ISSUE WAS DISCOVERED WHEN IT WAS VISUALLY OBSERVED BY THE MEDICAL STAFF. THERE WAS NO DEFECT OR DAMAGE NOTED TO THE BLOODLINES PRIOR TO THE OCCURRENCE OF THIS ISSUE. THE RN STATED THAT THE BLOODLINES APPEARED TO HAVE BEEN TORN BY THE MACHINE. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 100 ML. THERE WAS NO PATIENT INJURY, ADVERSE EVENTS, OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THIS EVENT. THE PATIENT SUCCESSFULLY COMPLETED TREATMENT ON A DIFFERENT MACHINE WITH NEW SUPPLIES. THE BLOOD PUMP ROTOR WAS REPLACED TO RESOLVE THE REPORTED ISSUE. THE MACHINE HAS BEEN RETURNED TO SERVICE. THE COMPLAINT DEVICE IS AVAILABLE TO BE RETURNED FOR PHYSICAL EVALUATION BY THE MANUFACTURER.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17541841 ↗
• MalfunctionJun 9, 2023Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY BIOMEDICAL TECHNICIAN (BMT) REPORTED DURING A PATIENT'S HEMODIALYSIS (HD) TREATMENT, A BLOOD PUMP (BP) ROTOR SLICED THE BP TUBING OPEN AND INDUCED AIR INSIDE THE LINES. FOLLOWING THE INCIDENT, DIALYSIS MODE WAS SIMULATED WITH BLOOD TUBING, SALINE, AND DIALYZER. THE BMT COULD NOT FIND ANYTHING THAT WOULD SLICE BLOOD TUBING AND NO BLOOD PUMP MODULE ERROR CODE WAS FOUND. THE MACHINE SELF TEST PASSED THREE TIMES AND FUNCTION CHECKS WERE COMPLETED. THE BLOOD MODULE WAS REPLACED AS A PRECAUTION. THE ESTIMATED BLOOD LOSS WAS UNKNOWN. THE MACHINE HAD A REPORTED 77 MACHINE HOURS. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT RECEIVED TO DATE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17096167 ↗
• MalfunctionMay 22, 2023Inadequate Ultra Filtration; Inadequate Ultra Filtration

  IT WAS REPORTED TO FRESENIUS THAT THE ULTRAFILTRATION (UF) TIME ON A 2008K2 MACHINE WAS NOT COUNTING DOWN DURING A PATIENT'S HEMODIALYSIS (HD) TREATMENT. LIMITED ADDITIONAL INFORMATION WAS PROVIDED BY THE CHARGE NURSE DURING FOLLOW-UP. THE PATIENT DID NOT EXPERIENCE A SERIOUS INJURY, ADVERSE EVENT, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THE REPORTED ISSUE. THE PATIENT COMPLETED TREATMENT WITHOUT MEETING THEIR UF GOAL (WHICH WAS NOT PROVIDED). THE MACHINE HAS SINCE BEEN REPAIRED AND RETURNED TO SERVICE. NO PARTS WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16974400 ↗
• DeathFeb 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 07/FEB/2023, A BIOMEDICAL TECHNICIAN (BIOMED) CONTACTED FRESENIUS TECHNICAL SUPPORT TO REQUEST AN INSPECTION ON A 2008T HEMODIALYSIS (HD) MACHINE. A PATIENT HAD EXPIRED ON THE MACHINE. ADDITIONAL INFORMATION WAS OBTAINED THROUGH FOLLOW-UP WITH THE REGISTERED NURSE AND THE BIOMED. THIS MALE PATIENT WAS A POST-OP (UNSPECIFIED) HOSPITAL PATIENT. ON (B)(6) 2023, THIS PATIENT COMPLETED HD TREATMENT WITHOUT COMPLICATION. AFTER THE COMPLETION OF TREATMENT AND PRIOR TO THE PATIENT BEING DISCONNECTED FROM THE MACHINE, THE PATIENT SUFFERED A HEART ATTACK. THE PATIENT WAS ADMINISTERED CARDIOPULMONARY RESUSCITATION (CPR) WITHOUT SUCCESS. IT WAS DISCOVERED THAT THE PATIENT ALSO HAD A BLOOD CLOT IN HIS LUNG. THE RN STATED THAT THE PATIENT¿S HEART ATTACK WAS NOT RELATED TO THE HD TREATMENT OR THE MACHINE, BUT THAT IT IS HOSPITAL POLICY FOR THE MACHINE TO BE INSPECTED WHEN A PATIENT DEATH OCCURS IN RELATION TO HD TREATMENT. FOLLOW-UP WITH THE BIOMED DOCUMENTED THAT THE FRESENIUS FIELD SERVICE TECHNICIAN HAD JUST COMPLETED THE MACHINE INSPECTION ON 09/FEB/2023. THE MACHINE CHECKED OUT GOOD AND PASSED ALL TESTS. THE MACHINE WAS BEING PUT BACK INTO SERVICE THAT DAY.

  Patient problems: Myocardial Infarction; Pulmonary Embolism

  MAUDE report 16351153 ↗
• MalfunctionNov 29, 2022Mechanical Problem; Reflux within Device; Mechanical Problem; Reflux within Device

  A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS TECHNICAL SUPPORT (TS) THAT A 2008T HEMODIALYSIS (HD) MACHINE HAD A SALINE BAG BACKFILL THAT OCCURRED DURING TESTING. THE BIOMED WAS PERFORMING TROUBLESHOOTING ON THE MACHINE WHEN IT OCCURRED. THE BIOMED SAID THE ORIGINAL PROBLEM WAS THAT THE MACHINE WAS GIVING A ¿SYSTEM LEAK, CAN¿T RUN¿ MESSAGE DURING BLEACH DISINFECT. THE MACHINE WAS ALSO GIVING A ¿FLOW INLET ERROR¿ IN RINSE MODE. THE BIOMED TOLD TS THAT THEY HAD REPLACED THE HEAT EXCHANGER. THE BIOMED CONFIRMED THE ¿AIR PUMP¿ AND ¿FLOW PUMP¿ WERE BOTH CALIBRATED AND REBUILT, AND THE WATER INLET PRESSURE WAS CALIBRATED. AFTER DOING THIS, THE BICARB PUMP WOULD NOT RUN. HOWEVER, WHEN THE BIOMED PLUGGED THE ACID INTO THE BICARB PUMP, THEY SAID THAT IT WORKED. THEY ORDERED A NEW DISTRIBUTION BOARD BECAUSE THEY THOUGHT THE ONE IN THE MACHINE WAS BAD. THE BIOMED CONFIRMED VISUALLY SEEING THE SALINE BAG REFILLING WITH FLUID. THEY WERE UNSURE IF THE MACHINE HAD THE CBE UPGRADES. THE BIOMED CONFIRMED THERE WERE NO FILLING PROGRAM ERRORS. THEY SAID THERE WAS "NOTHING WRONG WITH THE DRAIN LINE" WHEN ASKED IF IT WAS WITHIN THE LENGTH AND HEIGHT SPECIFICATION. THEY ALSO SAID

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15879835 ↗
• MalfunctionSep 29, 2022Thermal Decomposition of Device; Smoking; Sparking; Thermal Decomposition of Device; Smoking; Sparking

  A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED SPARKS AND SMOKE COMING FROM THE POWER SUPPLY OF A FRESENIUS 2008T HEMODIALYSIS (HD) MACHINE. THE STAFF WENT TO POWER ON THE MACHINE IN THE MORNING, AND A CAPACITOR BLEW ON THE POWER CONTROL BOARD. THERE WAS NO PATIENT INVOLVEMENT. THE STAFF REPORTEDLY HEARD THE CAPACITOR BLOW (OR SPARK), AND THE NOISE WAS FOLLOWED BY A BURNING SMELL AND SMOKE. THERE WERE NO REPORTS OF ANY FLAMES OR FIRE. A FRESENIUS FIELD SERVICE TECHNICIAN (FST) WAS THEN CALLED ONSITE TO EVALUATE THE MACHINE. THE FST CONFIRMED FINDING EVIDENCE OF THERMAL DAMAGE DURING THEIR INSPECTION OF THE MACHINE. WHEN THE FST OPENED THE BACK OF THE MACHINE, THEY FOUND CHARRING ON THE INTERIOR CABINET OF THE MACHINE¿S HOUSING. THERE WERE ALSO BURNT WIRES ON THE HEATER SWITCH AND EVIDENCE OF LIQUID STREAKS RUNNING DOWN THE BACK OF THE MACHINE AND THE POWER SUPPLY. THE FST FIXED THE MACHINE BY REPLACING THE ENTIRE POWER SUPPLY. THE MACHINE HAD 1,158 HOURS ON IT AT THE TIME OF THE REPAIR. THE FST WAS TOLD THAT THE FACILITY HAD PAST ISSUES WITH THE POWER OUTLETS IN THE ROOM WHERE THE 2008T MACHINE WAS HOUSED. IT WAS REPORTED THAT AN ELECTRICIAN WENT TO THE FACILITY AND ¿FIXED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15506194 ↗
• MalfunctionSep 14, 2022Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED THAT BLOOD LOSS OCCURRED DURING HEMODIALYSIS (HD) TREATMENT A FRESENIUS 2008T MACHINE. A BLOOD CLOT WAS IDENTIFIED IN THE TUBING OF THE BLOODLINES (BRAND UNKNOWN) AND THE BIOMED STATED THAT BLOOD LOSS WAS ALSO IDENTIFIED. THE MACHINE INITIALLY ALARMED WITH AN ARTERIAL PRESSURE ALARM MESSAGE AND THE PATIENT WAS TRANSFERRED TO A DIFFERENT MACHINE TO COMPLETE TREATMENT. IT WAS REPORTED THAT THERE WERE NO ADVERSE REACTIONS EXPERIENCED BY THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED, HOWEVER A RESPONSE WAS NOT RECEIVED. THE PATIENT'S ESTIMATED BLOOD LOSS (EBL) WAS NOT REPORTED. NO PARTS WERE RETURNED TO THE MANUFACTURER FOR A PHYSICAL EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15417613 ↗
• MalfunctionAug 23, 2022Sparking; Sparking

  A BIOMEDICAL TECHNICIAN (BIOMED) AT A USER FACILITY REPORTED THAT A FRESENIUS 2008K HEMODIALYSIS (HD) MACHINE SPARKED AND SMOKED. THE FIELD SERVICE TECHNICIAN (FST) FOUND THE POWER SUPPLY TO BE ¿BAD¿ AND REPLACED THE POWER SUPPLY. THE FST VERIFIED ALL OPERATIONS. THERE WAS NO PATIENT INVOLVED. THERE WAS NO HARM REPORTED TO ANYONE INVOLVED WITH OPERATING THE MACHINE. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15272620 ↗
• MalfunctionMar 24, 2022Mechanical Problem; Reflux within Device; Mechanical Problem; Reflux within Device

  A HEMODIALYSIS (HD) USER FACILITY REPORTED THAT A FRESENIUS 2008T HD MACHINE EXPERIENCED A SALINE BAG FILLING ERROR AND HAD HIGH TRANSMEMBRANE PRESSURE (TMP). A FRESENIUS FIELD SERVICE TECHNICIAN (FST) WAS DISPATCHED TO THE FACILITY TO EVALUATE THE MACHINE. ADDITIONAL DETAILS WERE REVEALED WHEN THE FST ARRIVED ONSITE. THE CLINIC MANAGER (CM) AT THE FACILITY EXPLAINED TO THE FST THAT THE MACHINE WAS SET UP INCORRECTLY AND THE SALINE BACKFILL WAS CAUSED BY USE ERROR. THE CM TOLD THE FST THAT ONE OF THE LINES WAS LEFT UNCLAMPED. PER THE CM, THEY CHANGED THE SETUP AND IT RESOLVED THE ISSUE. HOWEVER, THE TMP WAS STILL HIGH. IT WAS CONFIRMED THAT THIS OCCURRED DURING PRIMING; THERE WAS NO PATIENT INVOLVEMENT. DURING TESTING, THE FST COULD NOT DUPLICATE THE SALINE BAG FILLING ERROR OR THE HIGH TRANSMEMBRANE PRESSURE (TMP) PROBLEM. AS A PRECAUTION, THE FST CALIBRATED THE DIALYSATE PRESSURE. THEY ALSO CALIBRATED THE BICARB PUMP AND THE CONCENTRATE PUMP. THE FST CONFIRMED THAT THE CBE UPGRADES HAD BEEN COMPLETED ON THE MACHINE, AND THAT THERE WERE NO REPORTS OF THE MACHINE GIVING ANY FILLING PROGRAMS. THE FST SAID THE MACHINE WAS RETURNED TO SERVICE UPON THEIR DEPARTURE, AND THEY DID NOT HAV

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13873989 ↗
• DeathAug 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HOSPITAL BIOMEDICAL TECHNICIAN REQUESTED A HEMODIALYSIS (HD) MACHINE EVALUATION FROM FRESENIUS TECHNICAL SERVICES FOLLOWING AN EVENT WHERE AN HD PATIENT EXPIRED DURING HD THERAPY (EXACT DATE UNKNOWN) ON A FRESENIUS 2008T HD MACHINE. NO ADDITIONAL ADVERSE EVENT INFORMATION WAS PROVIDED DURING INTAKE. THE 2008T HD MACHINE WAS SEQUESTERED FOLLOWING THE EVENT(S). A FRESENIUS FIELD SERVICE TECHNICIAN (FST) WENT ONSITE AND PERFORMED FUNCTIONAL COMPLIANCE TESTING/VERIFICATION ON THE MACHINE. THE 2008T HEMODIALYSIS SYSTEM PERFORMED AS EXPECTED PER THE MANUFACTURERS SPECIFICATIONS. SUBSEQUENT ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION (E.G., TREATMENT RECORD, DISCHARGE SUMMARY, DEATH CERTIFICATE, PATIENT DEMOGRAPHICS) HAVE THUS FAR PROVEN UNSUCCESSFUL.

  Patient problems: Insufficient Information

  MAUDE report 12289889 ↗
• MalfunctionDec 29, 2020Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) CONTACTED FRESENIUS TECHNICAL SUPPORT (TS) TO REQUEST A REPLACEMENT BLOOD PUMP MODULE FOR A 2008T HEMODIALYSIS (HD) MACHINE. IT WAS REPORTED THAT THE BLOOD PUMP ROTOR HAD CUT INTO THE BLOOD TUBING SEGMENT DURING A PATIENT¿S TREATMENT, RESULTING IN APPROXIMATELY 2 ML OF BLOOD LOSS. AT FIRST, AN AIR DETECTOR ALARM SOUNDED, AND THE STAFF THEN NOTICED AIR IN THE BLOOD LINES. THE BLOOD PUMP WAS STOPPED, AND THE BLOOD TUBING WAS NOTED TO BE DAMAGED. THE PATIENT WAS MOVED TO ANOTHER MACHINE WHERE THEY COMPLETED THEIR TREATMENT. THE BIOMED TOLD TS THAT THE EVENT DID NOT RESULT IN ANY PATIENT HARM OR INJURY. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN PERFORMED WITHOUT SUCCESS. THUS FAR, NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 11087079 ↗
• DeathDec 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HOSPITAL BIOMEDICAL TECHNICIAN REQUESTED ONSITE SERVICE FROM A FRESENIUS FIELD SERVICE TECHNICIAN (FST) TO EVALUATE A 2008T HEMODIALYSIS (HD) MACHINE. IT WAS REPORTED THAT A PATIENT EXPIRED APPROXIMATELY TWO HOURS AFTER AN HD TREATMENT WAS PROVIDED ON THE SYSTEM. THERE WAS NO SPECIFIC ALLEGATION THIS EVENT WAS RELATED TO ANY DEFICIENCY OR MALFUNCTION OF FRESENIUS DEVICE(S) OR PRODUCT(S) IN THE INITIAL REPORTING. SUBSEQUENT ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION (E.G. DEMOGRAPHICS, MEDICAL HISTORY, END-STAGE RENAL DISEASE (ESRD) DEATH NOTIFICATION, DISCHARGE SUMMARY, AUTOPSY REPORT AND/OR DEATH CERTIFICATE) HAVE THUS FAR PROVEN UNSUCCESSFUL. THE HOSPITAL PROVIDED 2008T HD MACHINE WAS INSPECTED BY AN FST AND IT WAS VERIFIED THE MACHINE WAS OPERATING PROPERLY.

  Patient problems: Death

  MAUDE report 10983408 ↗
• InjuryNov 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN UNKNOWN PATIENT ON HEMODIALYSIS (HD) CODED (PATIENT HARM NOT SPECIFIED) ON A FRESENIUS 2008T DIALYSIS MACHINE AT (B)(6) HOSPITAL. THERE WERE NO DOCUMENTED MALFUNCTIONS OR ISSUES WITH THE HD MACHINE. A FRESENIUS FIELD SERVICE TECHNICIAN (FST) WAS CALLED ONSITE TO PERFORM A MACHINE EVALUATION. THE FST VERIFIED OPERATION OF THE MACHINE AND FOUND THE MACHINE TO BE FUNCTIONING AS PER SPECIFICATION. THERE WERE NO NOTED DISCREPANCIES WITH THE DIALYSIS MACHINE. DETAILS SURROUNDING THE PATIENT EVENT, INCLUDING PATIENT DEMOGRAPHICS, COMORBID CONDITIONS, HD TREATMENT INFORMATION, MEDICAL INTERVENTION, AND PATIENT OUTCOME, ARE UNKNOWN DESPITE MULTIPLE DUE DILIGENCE ATTEMPTS.

  Patient problems: Cardiac Arrest

  MAUDE report 10901811 ↗
• DeathAug 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED THAT THE ROTOR PIN ON A HEMODIALYSIS (HD) MACHINE WAS PROTRUDING, BUT WAS NOT CAUSING ANY SCAPING DAMAGE TO THE BLOOD PUMP PLATE. IT WAS REPORTED THAT THE ISSUE WAS FOUND DURING MACHINE INSPECTION. IT WAS REPORTED THAT THE MACHINE WAS REJECTED DUE TO AN ADVERSE PATIENT EVENT THAT OCCURRED WHILE THE PATIENT WAS IN TREATMENT (SPECIFIC DETAILS NOT PROVIDED). IT WAS REPORTED THAT THE MACHINE HAD NO PROBLEMS WHILE THE PATIENT EXPERIENCED THE ADVERSE EVENT. UPON FOLLOW-UP WITH THE BIOMED, IT WAS REPORTED THAT THE PATIENT SINCE PASSED AWAY. NO SPECIFIC INFORMATION COULD BE PROVIDED IN REGARDS TO THE PATIENT'S ADVERSE EVENT AND SUBSEQUENT EXPIRATION, HOWEVER IT WAS STATED THAT THE PATIENT WAS NOT UNDERGOING HD TREATMENT AT THE TIME OF PASSING. THE BIOMED CONFIRMED THAT THE MACHINE HAS APPROXIMATELY 1300 HOURS AND THAT THERE WERE NO OTHER DAMAGED PARTS. ALL THE PARTS ARE THE ORIGINAL FRESENIUS PARTS ON THE MACHINE. IT WAS CONFIRMED THAT THE ROTOR WAS REPLACED AND THE MACHINE IS BACK IN SERVICE. THE DAMAGED PART WAS REPORTED TO BE AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION. ADDITIONAL INFORMATION REGARDING THE ADVERSE EVENT

  Patient problems: Death; No Information

  MAUDE report 10364648 ↗