2008T BlueStar Hemodialysis Machine 191124Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 00840861102082), received between Nov 11, 2019 and Aug 7, 2026 — classified as 4 injuries, 28 malfunctions.

The most frequently reported specific device problem is “Thermal Decomposition of Device” (17 reports).

4 FDA recall records name this device's identifier, 4 still open.

17 other recalls cover devices cleared under the same FDA submission (K173972, K222952, K231125, K243237); they may or may not involve this specific model.

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-1867-2024 · Root cause: Device Design · Recall details · FDA record ↗

3. Sep 6, 2023Class IOpen, Classified

   Potential PCBA leaching from tubing of hemodialysis machines.

   Z-0032-2024 · Root cause: Device Design · Recall details · FDA record ↗

4. Jul 27, 2022Class IIOpen, Classified

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

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

Most reported problems

Recent adverse event reports

The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

• InjuryAug 7, 2026Adverse Event Without Identified Device or Use Problem

  It was reported to Fresenius technical support (TS) that a patient experienced hypernatremia during hemodialysis (HD) treatment on a Fresenius 2008T machine. In an email response from the user facility, it was documented that on (b)(6) 2026, the patient had a pre-dialysis treatment sitting blood pressure (BP) of 146/92 mmHg, pulse 81, respirations 18, temperature 97.5°F, and a weight of 69.0 kg. Additionally, it was noted that standard pre-treatment safety checks were completed which included HD machine self-tests, dialysate conductivity checks, and external Phoenix conductivity and pH verification. The Fresenius HD machine showed conductivity of 14.0 mS/cm with verified independent meter (Phoenix) conductivity of 14.0 mS/cm and pH 7.0 which were within facility parameters. There were no pre-treatment machine abnormalities or failed tests documented. It was documented that approximately 2.5 hours into the HD treatment the patient developed acute nausea, active vomiting, headache, and reported double vision, accompanied by marked hypertension and tachycardia. It was documented that the patient¿s blood pressure was 195/110 mmHg with persistent severe hypertension (range mid-160s to h

  Patient problems: Diplopia/Double Vision; Headache; High Blood Pressure/ Hypertension; Hypernatremia; Nausea; Tachycardia; Vomiting

  MAUDE report 50182372 ↗
• InjuryAug 7, 2026Adverse Event Without Identified Device or Use Problem

  It was reported to Fresenius technical support (TS) that a patient experienced hypernatremia during hemodialysis (HD) treatment on a Fresenius 2008T machine. In an email response from the user facility, it was documented that on (b)(6) 2026, the patient had a pre-dialysis treatment blood pressure (BP) of 146/78 mmHg with pulse of 75 bpm. Additionally, it was noted that standard pre-treatment safety checks were completed which included HD machine self-tests, dialysate conductivity checks, and external Phoenix conductivity and pH verification. There were no pre-treatment machine abnormalities or failed tests documented. It was documented that at the end of the HD treatment the patient developed severe hypertension with associated symptoms of nausea, headache, neck pain, and vomiting. The patient¿s BP averaged mid-160s/80s which then increased to 174/88 mmHg within the last hour of the HD treatment. The last documented BP was 188/98 mmHg with a pulse of 107 bpm at the end of the patient¿s HD treatment. As a result, the patient¿s HD treatment was discontinued and the patient was given clonidine 0.2 mg orally for hypertension. The treating nephrologist was notified of the event, and the

  Patient problems: Headache; High Blood Pressure/ Hypertension; Hypernatremia; Nausea; Neck Pain; Tachycardia; Vomiting

  MAUDE report 50182370 ↗
• MalfunctionJun 5, 2026Thermal Decomposition of Device

  A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED THAT A 2008T MACHINE WAS POWERING OFF WHEN ATTEMPTING TO PUT IT INTO A RINSE CYCLE OR DIALYSIS MODE. THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE EVENT. THE BIOMED REFERENCED THE TROUBLESHOOTING MANUAL AND IT ADVISED TO CHECK THE ACTUATOR BOARD. UPON INSPECTION OF THE BOARD, THE BIOMED NOTICED THERMAL DAMAGE (A BLACK SPOT). THE BIOMED REPLACED THE ACTUATOR BOARD WITH A SPARE AND THIS RESOLVED THE ISSUE. THERE WAS NO BURNING SMELL NOTED. THERE WERE NO SIGNS OF ANY SMOKE, SPARKS, OR FLAMES. THE BIOMED CONFIRMED THE MACHINE WAS PLUGGED INTO A HOSPITAL GRADE GROUND-FAULT CIRCUIT INTERRUPTER (GFCI) OUTLET AND IT DID NOT HAVE A HISTORY OF FAILING THE ELECTRICAL LEAKAGE TEST. THE BIOMED STATED THE MACHINE HAS ABOUT 16,000 HOURS ON IT. NO PHOTOS OF THE DAMAGED BOARD WERE AVAILABLE. THE BOARD WAS NOT AVAILABLE TO BE SENT BACK FOR EVALUATION AS IT WAS REPORTEDLY DISCARDED. THE MACHINE WAS RETURNED TO SERVICE UPON COMPLETION OF THE REPAIR. NO ADDITIONAL INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25408891 ↗
• InjuryMay 28, 2026Adverse Event Without Identified Device or Use Problem

  A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS TECHNICAL SUPPORT (TS) THAT A HEMODIALYSIS (HD) PATIENT SUFFERED A CARDIAC ARREST WHILE UNDERGOING HD THERAPY ON A 2008T HD MACHINE. FOLLOW-UP WITH THE INPATIENT CHARGE NURSE (ICN) REVEALED THE PATIENT SUFFERED A CARDIAC ARREST WHILE UNDERGOING HD ON (B)(6) 2026. THE ICN REPORTED HD WAS IMMEDIATELY TERMINATED AND CARDIOPULMONARY RESUSCITATIVE (CPR) MEASURES WERE PERFORMED. THE PATIENT WAS SUCCESSFULLY REVIVED AND THEY WERE TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU) FOLLOWING THE SERIOUS ADVERSE EVENTS. THE PATIENT REMAINED IN THE ICU AT THE TIME OF FOLLOW-UP AND WAS UNDERGOING HD WITHOUT ANY KNOWN ISSUES. PER THE ICN, THE HD MACHINE WAS PULLED FROM SERVICE DUE TO POLICY AND PROCEDURE FOLLOWING A CODE SITUATION, AND NOT BECAUSE A FRESENIUS DEVICE DEFICIENCY OR MALFUNCTION WAS SUSPECTED. THE HD MACHINE WAS FIRST EVALUATED BY THE BIOMED AND FUNCTIONED AS EXPECTED. A FRESENIUS FIELD SERVICE TECHNICIAN (FST) WAS DISPATCHED TO PERFORM POST-EVENT FUNCTIONAL COMPLIANCE TESTING ON 8/MAY/2026. THE 2008T HD MACHINE PASSED ALL FUNCTIONAL COMPLIANCE CHECKS AND WAS RETURNED TO SERVICE THAT SAME DAY.

  Patient problems: Cardiac Arrest

  MAUDE report 25325598 ↗
• MalfunctionMar 20, 2026Thermal Decomposition of Device

  A BIOMEDICAL TECHNICIAN (BIOMED) AT A USER FACILITY REPORTED THAT A FRESENIUS 2008T HEMODIALYSIS (HD) MACHINE HAD CHARRED WIRES ON THE DEAERATION MOTOR. THE CHARRED WIRES WERE NOTICED DURING MACHINE REPAIR FOLLOWING A FLOW INLET ERROR. 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 REPLACED THE PARTS, WHICH RESOLVED THE ISSUE. THE MACHINE WAS RETURNED TO SERVICE AT THE USER FACILITY WITHOUT ISSUE AND WITHOUT REOCCURRENCE OF THE EVENT. THE PARTS ARE NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24651312 ↗
• MalfunctionOct 7, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY BIOMEDICAL TECHNICIAN (BMT) REPORTED TO TECHNICAL SUPPORT THAT A 2008T MACHINE EXPERIENCED A CDX PROBLEM DURING TREATMENT. NO PATIENT COMPLICATIONS WERE NOTED AND THE PATIENT FINISHED TREATMENT. THE FACILITY DECIDED TO POWER DOWN THE MACHINE DURING TREATMENT. WHEN THE MACHINE WAS POWERED BACK UP, THE MACHINE STARTED WITH A MANDATORY FORCED TEST. THE BMT WAS ADVISED THAT THE POWER DOWN HAD TO HAVE TAKEN LONGER THAN ONE MINUTE BEFORE POWERING BACK ON TO THE "SELECT PROGRAM" SCREEN, WHICH WOULD INITIATE A FORCED TEST TO BE PERFORMED. UPON FOLLOW-UP, THE BMT STATED THE PATIENT COMPLETED TREATMENT ON THE SAME MACHINE BUT WHEN THE MACHINE WAS POWERED OFF DURING THE START OF THE TREATMENT, NOT ALL OF THE BLOOD WAS RINSED BACK TO THE PATIENT. THE BMT CONFIRMED MACHINE WAS OFF FOR MORE THAN ONE MINUTE DURING TREATMENT. THE BMT SAID A NEW FUNCTIONAL BOARD WITH SOFTWARE VERSION 2.84 HAD BEEN INSTALLED ON THE MACHINE AND WAS WHAT CAUSED THE DELAYED START UP TIME AND RESULTED IN THE CDX ISSUES. UPON ADDITIONAL FOLLOW-UP, THE BMT CLARIFIED THE ISSUE WAS THAT AT THE START OF TREATMENT A PATIENT WAS DIALYZING ON A FRESENIUS HEMODIALYSIS (HD) MACHINE WHEN STAFF NOTICED CHAIRSIDE WAS

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23240777 ↗
• MalfunctionAug 25, 2025Thermal Decomposition of Device; Thermal Decomposition of Device

  A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS TECHNICAL SUPPORT (TS) THAT A 2008T HEMODIALYSIS MACHINE HAD A BURNT WIRE ON THE HEATER ROD (BLUE WIRE), AND THE TERMINAL BLOCK WAS BURNT. THE BIOMED STATED THERE WERE THUNDERSTORMS IN THE AREA WHICH MAY HAVE CONTRIBUTED TO OR CAUSED THE ISSUE. TS ADVISED THE BIOMED TO REPLACE THE HEATER ROD AND DISTRIBUTION BOARD. NO FURTHER DETAILS WERE PROVIDED IN THE INITIAL REPORTING. 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 22891615 ↗
• MalfunctionJul 3, 2025Thermal Decomposition of Device; Thermal Decomposition of Device

  A USER FACILITY'S BIOMEDICAL TECHNICIAN (BMT) REPORTED THAT DURING MACHINE INSTALLATION, A 2008T HEMODIALYSIS (HD) MACHINE WOULD POWER UP TO 15% AND THEN REBOOT. A FRESENIUS FIELD SERVICE TECHNICIAN (FST) WAS CALLED ONSITE AND AFTER RESEATING THE BOARDS AND CONNECTIONS, THEY SAW A VISIBLE PUFF OF SMOKE WITH A BURN MARK ON C1/ C2 OF THE MOTHERBOARD. THEY ORDERED A MOTHERBOARD AND POWER SUPPLY FOR THE CUSTOMER. 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 MOTHER BOARD AND POWER SUPPLY WERE THE ORIGINAL FRESENIUS PART ON THE MACHINE. THE BMT REPORTED THAT THERE WAS NO MELTING, BURNING SMELL, 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 3 HOURS AND IS PLUGGED INTO A HOSPITAL GRADE GROUND-FAULT CIRCUIT INTERRUPTER (GFCI) OUTLET. THE CUSTOMER RECEIVED AND INSTALLED THE PARTS TO RESOLVE THE ISSUE. THE MOTHER BOARD AND POWER SUPPLY ARE NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22395328 ↗
• MalfunctionMar 21, 2025Thermal Decomposition of Device; Thermal Decomposition of Device

  A USER FACILITY'S BIOMEDICAL TECHNICIAN (BMT) REPORTED THAT A 2008T HEMODIALYSIS (HD) MACHINE FAILED SENDING DATA TO THE ACTUATOR BOARD DURING POWER UP. DURING REPAIR, THE BMT NOTED THAT THERE WERE BURN MARKS AND CHARRING ON THE 24 VOLT CABLE, MOTHERBOARD AND THE FUNCTIONAL BOARD. 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 PARTS WERE THE ORIGINAL FRESENIUS PARTS ON THE MACHINE. THE BMT REPORTED THAT THERE WAS NO MELTING, BURNING SMELL, SMOKE, SPARK, FLAME, OR ARCING OBSERVED. THE BMT REPORTED THAT THE MACHINE HAS NOT HAD ANY PAST PROBLEMS WITH FAILING THE ELECTRICAL LEAKAGE TEST AND THAT THERE WAS NO DAMAGE OBSERVED TO ANY OTHER COMPONENTS. THE MACHINE HOURS WERE UNKNOWN. THE MACHINE IS PLUGGED INTO A HOSPITAL GRADE GROUND-FAULT CIRCUIT INTERRUPTER (GFCI) OUTLET. THE BMT IS WAITING FOR PARTS TO ARRIVE TO REPAIR THE MACHINE. NO SAMPLES ARE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21664295 ↗
• MalfunctionMar 5, 2025Thermal Decomposition of Device; Thermal Decomposition of Device

  A USER FACILITY'S BIOMEDICAL TECHNICIAN (BMT) REPORTED THAT A 2008T HEMODIALYSIS (HD) MACHINE WOULD NOT CALIBRATE THE DEAERATION PRESSURE DURING CALIBRATION/ SERVICE MODE. UPON FOLLOW UP, THE BMT STATED THAT HE REPLACED THE DEAERATION BOARD TO RESOLVE THE REPORTED ISSUE. HE ALSO REPORTED THAT THERE WAS A POPPING SOUND AND SMOKE COMING FROM THE ACTUATOR BOARD BECAUSE IT HAD BEEN CALIBRATED AT HIGH POWER. 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 ACTUATOR BOARD AND DEAERATION BOARD WERE THE ORIGINAL FRESENIUS PARTS ON THE MACHINE. THE BMT REPORTED THAT THERE WAS NO MELTING, 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 12,069 HOURS AND IS PLUGGED INTO A HOSPITAL GRADE GROUND-FAULT CIRCUIT INTERRUPTER (GFCI) OUTLET. THE BMT REPLACED THE ACTUATOR BOARD, WHICH RESOLVED THE ISSUE. THE BMT REPORTED THAT THE MACHINE HAS BEEN RETURNED TO SERVICE WITHOUT ISSUE. THE SAMPLES ARE NOT AVAILABLE TO BE RETURNED TO T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21525958 ↗
• MalfunctionJan 15, 2025Thermal Decomposition of Device; Thermal Decomposition of Device

  A USER FACILITY'S BIOMEDICAL TECHNICIAN (BMT) REPORTED THAT A 2008T HEMODIALYSIS (HD) MACHINE'S HEATER ROD SPLIT AND PRODUCED A BURNING SMELL DURING HEAT DISINFECTION MODE. NO PATIENT WAS INVOLVED. IT IS UNKNOWN IF THE MACHINE HAS BEEN RETURNED TO SERVICE. THE COMPLAINT DEVICE IS AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21159578 ↗
• MalfunctionDec 6, 2024Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY'S BIOMEDICAL TECHNICIAN (BMT) REPORTED THAT A 2008T HEMODIALYSIS (HD) MACHINE'S BLOOD PUMP ROTOR ROLLER GUIDE PIN CUT A BLOODLINE 1 HOUR INTO A PATIENT'S HD TREATMENT. THE MACHINE, A FRESENIUS 2008T MACHINE, ALARMED APPROPRIATELY WITH AN ¿AIR IN LINE¿ ALARM. A FRESENIUS DIALYZER WAS ALSO IN USE. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 500ML. THERE WAS NO PATIENT 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. THE BLOODLINE WAS DISCARDED. FOLLOW UP WITH THE BMT REVEALED THAT THAT THE MACHINE HAS NOT BEEN RETURNED TO SERVICE PENDING A REPLACEMENT BLOOD PUMP ROTOR. NO SAMPLE IS AVAILABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20868101 ↗
• MalfunctionOct 21, 2024Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY'S BIOMEDICAL TECHNICIAN (BMT) REPORTED THAT A 2008T HEMODIALYSIS (HD) DISPLAYED A ¿REMOVE USB DEVICE 2¿ MESSAGE DURING A PATIENT'S HD TREATMENT. UPON FOLLOW UP, THE BMT SAID THAT INSERTING A USB IN THE USB PORT RESOLVED THE ISSUE, BUT HE WAS NOT SATISFIED WITH THAT SOLUTION. A FRESENIUS FIELD SERVICE TECHNICIAN (FST) WAS CALLED ONSITE AND REPLACED THE USER INTERFACE (UI)/ MICS BOARD AND THE USB ADAPTOR CABLE. MACHINE FUNCTIONAL TESTS WERE COMPLETED AND PASSED ONSITE AFTER REPAIR. THE PATIENT¿S BLOOD WAS NOT RETURNED FOLLOWING THIS INCIDENT. FOLLOW UP WITH THE CLINIC MANAGER REVEALED THAT THE ISSUE OCCURRED 48 MINUTES INTO TREATMENT. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 150ML. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THIS EVENT. FRESENIUS BLOODLINES WERE ALSO IN USE. THE PATIENT WAS RESTARTED ON A NEW MACHINE AND TREATMENT COMPLETED SUCCESSFULLY WITH NEW SUPPLIES. THE COMPLAINT DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20493508 ↗
• MalfunctionSep 20, 2024Thermal Decomposition of Device; Thermal Decomposition of Device

  A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS TECHNICAL SUPPORT (TS) THAT A 2008T HEMODIALYSIS (HD) MACHINE HAD A BURNT SPOT ON THE BICARB PUMP CABLE. THE BIOMED REPORTED THAT THERE WERE SEVERAL ISSUES WITH THE MACHINE. THE MACHINE WAS EXPERIENCING A FLOW INLET ERROR IN RINSE MODE AND A HIGH FLOW ERROR IN DIALYSIS MODE. THERE WERE NO REPORTED AUDIBLE ALARMS. THE BIOMED HAD ALREADY CHANGED VALVE 30 PRIOR TO CALLING TS. THE BIOMED REPORTED THAT BOTH CHECK VALVES (63 AND 64) WERE LEAKING AND WERE SUBSEQUENTLY REPLACED. THE BIOMED SAID THERE WAS CRYSTALLIZED FLUID ON THE VALVES. THE CHECK VALVES WERE DISCARDED. UPON FURTHER INSPECTION THE BIOMED IDENTIFIED A BURN MARK ON THE BICARB PUMP CABLE. THE BIOMED CONFIRMED THERE WAS NO DAMAGE NOTED ON THE BICARB PUMP ITSELF, THE THERMAL DAMAGE WAS ISOLATED TO THE CABLE. TS HAD ADVISED THE BIOMED TO REPLACE VALVE 26, THE FLOW MOTOR AND PUMP HEAD, OR THE ACTUATOR BOARD AND CABLE. UPON FOLLOW-UP, THE BIOMED REPORTED THAT THEY ALSO REPLACED TRANSDUCER #9, THE FLOW SWITCH, AND THE BICARB PUMP AND CABLE. THE BIOMED HAD ALSO CALIBRATED THE INLET WATER, DEAERATION, LOADING, AND FLOW PRESSURES. THE BIOMED DID NOT HAVE TO REPLACE V

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20270680 ↗
• MalfunctionAug 23, 2024Thermal Decomposition of Device; Thermal Decomposition of Device

  A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS TECHNICAL SERVICES THAT THE 2008T MACHINE EXPERIENCED LOW TEMPERATURE DURING HEAT DISINFECTION. THERE WERE NO DIAGNOSTIC MESSAGES OR AUDIBLE ALARMS EXPECTED. THE EXACT TEMPERATURE WAS NOT PROVIDED BUT IT WAS REPORTED THAT THE TEMPERATURE WOULD NOT RISE PAST 25°C ON THE EXTERNAL METER DURING THE TEMPERATURE CONTROL CALIBRATION. UPON INITIAL FOLLOW-UP, THE BIOMED STATED THE MACHINE WAS PLACED INTO HEAT DISINFECTION AND SUDDENLY STOPPED. UPON TROUBLESHOOTING, A BURNT WIRE WAS IDENTIFIED ON THE BICARBONATE (BICARB) PUMP. DURING FURTHER FOLLOW-UP, THE BIOMED STATED THE RIBBON CABLE ON THE ACID AND BICARBONATE PUMPS WERE CINDERED. THERE WAS NO REPORTED BURNING SMELL, SMOKE, SPARK, FLAME, OR ARCING. THE ACID AND BICARBONATE PUMPS WERE REPLACED TO RESOLVE THE IDENTIFIED THERMAL DAMAGE. THE ACTUATOR AND FUNCTIONAL BOARDS WERE ALSO REPLACED TO RESTORE FUNCTIONALITY TO THE ACID AND BICARB PUMPS, RESPECTIVELY. THE LOADING PRESSURE VALVE WAS REPLACED FOR BEING NOISY. UPON FURTHER FOLLOW-UP THE BIOMED STATED THAT REPLACING THE HEATER RESOLVED THE INITIAL LOW TEMPERATURE ISSUE. THE MACHINE PASSED FUNCTIONAL TESTING AND WAS RETUR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20053826 ↗
• MalfunctionMar 28, 2024Fluid/Blood Leak; Fluid/Blood Leak

  A BIOMEDICAL TECHNICIAN (BMT) REPORTED TO TECHNICAL SUPPORT THAT A 2008T MACHINE'S BLOOD PUMP ROTOR CUT THE DIALYSATE BLOOD PUMP TUBING DURING A PATIENT'S HEMODIALYSIS (HD) TREATMENT. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) IS UNKNOWN. 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. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE FILE WILL BE UPDATED ACCORDINGLY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18992174 ↗
• MalfunctionMar 22, 2024Thermal 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 BURN MARK (DISCOLORATION) INSIDE THE POWER PLUG. THE BURNED POWER PLUG WAS NOTICED DURING REGULAR INSPECTION. 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 PLUG WAS THE ORIGINAL FRESENIUS PART ON THE MACHINE. THE BIOMED REPORTED THAT THERE WAS NO MELTING, BURNING SMELL, SMOKE, SPARK, FLAME, OR ARCING OBSERVED. THE BIOMED 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 HOURS WAS UNKNOWN. THE MACHINE IS PLUGGED INTO A HOSPITAL GRADE GROUND-FAULT CIRCUIT INTERRUPTER (GFCI) OUTLET. THE BIOMED REPLACED THE PLUG, WHICH RESOLVED THE ISSUE. THE BIOMED REPORTED THAT THE MACHINE HAS BEEN RETURNED TO SERVICE WITHOUT ISSUE. THE POWER PLUG WAS NOT RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18960533 ↗
• MalfunctionFeb 29, 2024Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY¿S BIOMEDICAL TECHNICIAN (BMT) REPORTED THAT A BLOOD LEAK OCCURRED DURING A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE BLOOD LEAK WAS COMING FROM THE COMBI SET BLOODLINE, BUT IT WAS REPORTEDLY CAUSED BY THE BLOOD PUMP ROTOR. A TEAR WAS IDENTIFIED IN THE LINE, WHICH WAS REPORTEDLY DAMAGED BY THE BLOOD PUMP ROTOR. THE BLOOD LEAK OCCURRED APPROXIMATELY 3 HOURS INTO TREATMENT. THE MACHINE ALARMED APPROPRIATELY WITH AN AIR DETECTOR ALARM. THE PATIENT¿S BLOOD WAS RETURNED, AND A MINIMAL AMOUNT OF BLOOD WAS LOST, BUT COULD NOT BE QUANTIFIED. 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 EVENTS. TO RESOLVE THE REPORTED ISSUE, THE BIOMED REPLACED THE BLOOD PUMP ROTOR. THE BLOOD PUMP ROTOR WAS REPORTED TO BE AVAILABLE FOR EVALUATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18809283 ↗
• MalfunctionOct 23, 2023Thermal 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 ACTUATOR BOARD. A CHIP ON THE BOARD APPEARED TO BE BLACK. THE BURNED BOARD WAS NOTICED DURING MACHINE REPAIR AFTER THE 2008T MACHINE WAS INITIALLY PULLED FROM SERVICE FOR RECEIVING AN "ACID PUMP NO END OF STROKE (EOS)" ERROR THAT OCCURRED DURING RINSE MODE AND DUE TO GRINDING NOISES COMING FROM THE BICARBONATE PUMP. THE BICARBONATE PUMP WAS REPLACED BUT THE PROBLEM PERSISTED. 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 8,065 HOURS AND THE ACTUATOR BOARD 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 ACTUATOR BOARD. THE BIOMED REPLACED THE ACTUATOR BOARD, WHICH RESOLVED THE ISSUE. THE UNIT WAS RETURNED TO SERVICE AT THE USER FACILITY WITHOUT ISSUE AND WITHOUT REOCCURRENCE OF THE EVENT. THE ACTUATOR BOARD IS AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17985531 ↗
• MalfunctionJul 24, 2023Thermal Decomposition of Device; Smoking; Thermal Decomposition of Device; Smoking

  A BIOMEDICAL TECHNICIAN (BIOMED) AT A USER FACILITY REPORTED THAT A FRESENIUS 2008T HEMODIALYSIS (HD) MACHINE HAD A BURNING SMELL AND A BURNT CAPACITOR COMPONENT ON THE MOTHER BOARD. THERE WAS MINOR SMOKE NOTICED, HOWEVER THE BIOMED CONFIRMED THAT THE SMOKE DETECTORS DID NOT GO OFF AND THERE WAS NO NEED TO USE A FIRE EXTINGUISHER OR EVACUATE THE FACILITY AS A RESULT OF THIS INCIDENT. 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 3,800 HOURS AND THE MOTHER BOARD 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 BURNT CAPACITOR. THE BIOMED REPLACED THE MOTHER BOARD, WHICH RESOLVED THE ISSUE. THE UNIT WAS RETURNED TO SERVICE AT THE USER FACILITY WITHOUT ISSUE AND WITHOUT REOCCURRENCE OF THE EVENT. THE MOTHER BOARD HAS BEEN DISCARDED AND IS NOT AVAILABLE FOR RETURN TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17381968 ↗
• MalfunctionJul 12, 2022Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY BIOMEDICAL TECHNICIAN REPORTED THAT A MINOR BLOOD LEAK OCCURRED DURING A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE MACHINE, A FRESENIUS 2008T MACHINE, ALARMED APPROPRIATELY WITH A BLOOD LEAK ALARM. THERE WAS NO PATIENT INJURY, ADVERSE EVENTS, OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THIS EVENT. THE PATIENT WAS RESTARTED ON A NEW MACHINE AND TREATMENT COMPLETED SUCCESSFULLY. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14989326 ↗
• InjuryJan 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS TECHNICAL SUPPORT THAT A PATIENT CODED WHILE ON A 2008 HEMODIALYSIS (HD) MACHINE AND PASSED AWAY LATER THAT DAY. THE BIOMED STATED THAT THE ADVERSE EVENT WAS NOT THOUGHT TO BE MACHINE RELATED. THE BIOMED WANTED TO KNOW IF IT WAS MANDATORY FOR A FRESENIUS TECHNICIAN TO EVALUATE THE MACHINE. ADDITIONAL INFORMATION WAS OBTAINED THROUGH FOLLOW-UP WITH THE HD CLINIC DIRECTOR. THE PATIENT WAS IN A REGULARLY SCHEDULED HD TREATMENT WHEN THEY CODED. THE TREATMENT WAS INITIATED AT 6:30AM AND THE ADVERSE EVENT OCCURRED AT 9:30AM. LATER THAT DAY (EXACT TIME NOT PROVIDED), THE PATIENT EXPIRED. THE PATIENT HAD BEEN DISCHARGED FROM THE CLINIC THREE DAYS PRIOR TO THE DIALYSIS TREATMENT WHERE THEY WERE INFORMED THEIR EJECTION FRACTION (EF) WAS 5-10% AND THAT THEY WOULD REQUIRE A HEART TRANSPLANT. IT WAS REPORTED THAT THE CODING EVENT AND DEATH WERE NOT RELATED TO THE DIALYSIS TREATMENT OR USE OF THE 2008 HD MACHINE. CULTURES WERE SENT OUT ON THE DIALYSATE WHICH ALL RESULTED NORMAL. THE LINES WERE RETAINED UNTIL THE MACHINE EVALUATIONS WERE COMPLETED. ALL EVALUATIONS WERE COMPLETED WITH NO FINDINGS. THE EVENT WAS ATTRIBUTED TO THE

  Patient problems: Cardiac Arrest

  MAUDE report 13143963 ↗
• MalfunctionJun 28, 2021Thermal 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 HEATER ROD. THE MACHINE TRIPPED THE GROUND-FAULT CIRCUIT INTERRUPTER (GFCI) OUTLET AND POWERED OFF AFTER THE BIOMED ATTEMPTED TO PUT IT INTO RINSE MODE. THE BIOMED EVALUATED THE MACHINE AND FOUND THAT THE HEATER ROD APPEARED WARPED AND CRACKED AND EXPANDED FROM ITS NORMAL SIZE. 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 3,078 HOURS AND THE HEATER ROD 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 HEATER ROD. THE BIOMED REPLACED THE HEATER ROD, WHICH RESOLVED THE ISSUE. THE UNIT WAS RETURNED TO SERVICE AT THE USER FACILITY WITHOUT ISSUE AND WITHOUT REOCCURRENCE OF THE EVENT. THE HEATER ROD IS AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12080514 ↗
• MalfunctionMay 25, 2021Inadequate Ultra Filtration; Inadequate Ultra Filtration

  A USER FACILITY MANAGER REPORTED THAT THE ULTRAFILTRATION (UF) GOAL AND TREATMENT TIME CHANGED ON A FRESENIUS 2008T HEMODIALYSIS (HD) MACHINE AFTER THE INITIATION OF THE PATIENT'S TREATMENT. THE MACHINE WAS PROGRAMED TO A UF GOAL OF 800 ML AND TREATMENT TIME OF 3 HOURS, HOWEVER, AFTER INITIATION IT WAS NOTED THAT THE MACHINE DEFAULTED TO A UF RATE OF 70 ML/HOUR. THE CLINICAL MANAGER STATED THAT THE MACHINE COULD NOT MANUALLY BE ADJUSTED TO WHAT WAS PROGRAMMED BY THE STAFF. THE UF WAS NOT TURNED OFF. DURING THE TREATMENT THE PATIENT'S BLOOD PRESSURE DROPPED. A SALINE BOLUS OF 55 CC WAS ADMINISTERED TO THE PATIENT PER STANDING ORDER (ORDERED BY THE PHYSICIAN). THE PATIENT HAS BEEN DIAGNOSED WITH SPINA BIFIDA. THE CLINICAL MANAGER EXPLAINED THAT THE PATIENT'S DROP IN BLOOD PRESSURE WAS RELATED TO THIS DIAGNOSIS AND NOT A COMPLICATION OF TREATMENT. THERE WAS NO PATIENT INJURY, ADVERSE EVENTS, OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THE REPORTED EVENT. PER THE CLINICAL MANAGER, THE REPORTED EVENT COULD NOT BE DUPLICATED DURING TESTING AND THE MACHINE WAS RETURNED TO SERVICE AND NO PARTS WERE REPLACED OR MACHINE REPAIRS MADE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11879173 ↗
• MalfunctionMay 17, 2021Inadequate Ultra Filtration; Inadequate Ultra Filtration

  A USER FACILITY MANAGER REPORTED THAT THE ULTRAFILTRATION (UF) GOAL AND TREATMENT TIME CHANGED ON A FRESENIUS 2008T HEMODIALYSIS (HD) MACHINE AFTER THE INITIATION OF THE PATIENT'S TREATMENT. THE MACHINE WAS PROGRAMED TO A UF GOAL OF 800 ML AND TREATMENT TIME OF 3 HOURS, HOWEVER, AFTER INITIATION IT WAS NOTED THAT THE MACHINE DEFAULTED TO A UF RATE OF 70 ML/HOUR. THE CLINICAL MANAGER STATED THAT THE MACHINE COULD NOT MANUALLY BE ADJUSTED TO WHAT WAS PROGRAMMED BY THE STAFF. THE UF WAS NOT TURNED OFF AT ALL DURING TREATMENT. AT THAT POINT, TREATMENT WAS TERMINATED. THERE WAS NO PATIENT INJURY, ADVERSE EVENTS, OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THE REPORTED EVENT. THE PATIENT DID NOT HAVE ANY COMPLAINTS OR SYMPTOMS RELATED TO THE REPORTED EVENT AND NO ADDITIONAL TREATMENTS WERE REQUIRED. PER THE CLINICAL MANAGER, THE REPORTED EVENT COULD NOT BE DUPLICATED DURING TESTING AND THE MACHINE WAS RETURNED TO SERVICE AND NO PARTS WERE REPLACED OR MACHINE REPAIRS MADE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11839001 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K173972, K222952, K231125, K243237. One submission often covers many models, so check the product and lot details in each record.

• Z-3017-2026 · Jun 30, 2026 · Open, Classified
  Fresenius Medical Care, 2008T BlueStar Hemodialysis Machine, Model Numbers: 191126, 191130.
• Z-1868-2024 · Apr 17, 2024 · Open, Classified
  2008T BlueStar Hemodialysis Machine, Model 191126 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A.
• Z-1870-2024 · Apr 17, 2024 · Open, Classified
  2008T BlueStar Hemodialysis Machine, Model 191130 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A
• Z-1869-2024 · Apr 17, 2024 · Open, Classified
  2008T BlueStar Hemodialysis Machine, Model 191128 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A.
• Z-0035-2024 · Sep 6, 2023 · Open, Classified
  2008T HD SYS. W/O CDX W/BIBAG BLUESTAR
• Z-0033-2024 · Sep 6, 2023 · Open, Classified
  2008T HD SYS. CDX W/BIBAG BLUESTAR
• Z-0029-2024 · Sep 6, 2023 · Open, Classified
  2008T Hemodialysis System without CDX
• Z-0030-2024 · Sep 6, 2023 · Open, Classified
  2008T Hemodialysis System w/Bibag
• Z-0028-2024 · Sep 6, 2023 · Open, Classified
  2008T Hemodialysis SYS, with CDX
• Z-0031-2024 · Sep 6, 2023 · Open, Classified
  2008T GEN 2 Bibag without CDX
• Z-0034-2024 · Sep 6, 2023 · Open, Classified
  2008T HD SYS. W/O CDX BLUESTAR
• Z-1748-2020 · Mar 12, 2020 · Open, Classified
  Fresenius 2008T Hemodialysis Machine: Part Number Description 190573 2008T HEMODIAL YSIS SYS. OLC/DIASAFE PLUS; 190713 2008T HEMODIAL YSIS SYS., with CDX; 190766 2008T HEMODIAL YSI
• Z-1749-2020 · Mar 12, 2020 · Open, Classified
  Fresenius 2008T BlueStar Hemodialysis Machine Part Number Description: 191124 2008T HD SYS. CDX BLUEST AR; 191126 2008T HD SYS. CDX W/BIBAG BLUEST AR; 191128 2008T HD SYS. W/O CDX
• Z-1529-2020 · Jan 29, 2020 · Terminated
  Honeywell Pressure Transducer- Part Number: 370506-22. It is a component used in 2008T, Common Name: Hemodialysis Delivery System; 2008T HD SYS. BLUE STAR; 2008K2, Common Name: Hem
• Z-1699-2019 · Apr 3, 2019 · Terminated
  2008T BlueStar Machine Software v.2.72-Hemodialysis machine Model Number: 191126 - Product Usage: The 2008T hemodialysis machine is indicated for acute and chronic dialysis thera

…and 2 more.