2008T BlueStar Hemodialysis Machine 191126Recalls & reported problems

Summary

The FDA's MAUDE database contains 441 adverse event reports that list this exact device (DI 00840861102099), received between Nov 14, 2018 and Sep 29, 2026 — classified as 10 deaths, 17 injuries, 414 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (177 reports).

5 FDA recall records name this device's identifier, 5 still open.

16 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. Jun 30, 2026Class IIOpen, Classified

   Fresenius Medical Care Renal Therapies Group, LLC (FMCRTG) has received complaints regarding flow-, no water-, or temperature-related alarms with the 2008T BlueStar Hemodialysis machines.

   Z-3017-2026 · Root cause: Process control · Recall details · FDA record ↗

2. 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 ↗

3. 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-1868-2024 · Root cause: Device Design · Recall details · FDA record ↗

4. Sep 6, 2023Class IOpen, Classified

   Potential PCBA leaching from tubing of hemodialysis machines.

   Z-0033-2024 · Root cause: Device Design · Recall details · FDA record ↗

5. 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 441 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Fluid/Blood Leak; Device Damaged by Another Device

  A nurse reported that there was a blood leak during a hemodialysis (HD) treatment. The machine began alarming "air". Once inspected, it was noted that blood was leaking from the line on the blood pump area. After removal of combi set in blood pump, there was a puncture mark in the tubing allowing blood to leak and air to get into the section of the blood line that was in the blood pump. In a follow up, the nurse said the blood leak occurred approximately 2 hours 15 min after Hemodialysis (HD) treatment was started. There was and air detected alarm on the 2008T machine. An Optiflux dialyzer was being used.The leak was due to the combiset line being punctured or split. Obvious damage to the bloodline was noticed when the line was removed from the blood pump rotor.There were no loose connections noted. There was damage seen to the tubing. The rotor part number is F40014866. It was determined the blood pump rotor was faulty and it was replaced.It had not been replaced before. The rotor was an affected rotor. The patient¿s blood loss was approximately 100mL. There was no patient injury, intervention or adverse event. The patient completed treatment with new bloodlines and a different ma

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50935161 ↗
• MalfunctionSep 17, 2026No Audible Alarm; Alarm Not Visible

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50808535 ↗
• MalfunctionAug 25, 2026Thermal Decomposition of Device

  A Biomedical Technician (BMT) reported to Technical Support that a 2008T machine was powering down as soon as it goes into a mode. Technical Support had the BMT turn off the heater breaker. When going into rinse, the machine stayed on. Technical Support advised swapping the heater rod. Upon follow up, the BMT replaced the heater cord after it was found to be burnt out to resolve the issue. The machine is back in service. It was confirmed that there was no patient involvement, harm, or adverse events associated with the reported issue. No pictures were provided. No part number or Lot number of the part was provided. No parts are available for return. Upon further follow up, the BMT reported that there was no observed burning smell, smoke, spark, flame, arcing. The machine powering down occurred during setup for treatment. The BMT was not at the machine and could not report the machine hours, software version, or e-codes. The cord was the original part on the machine. The machine has not had any past problems with failing electrical leakage tests. The machine is plugged into a hospital grade ground-fault circuit interrupter (GFCI) outlet. There was no damage to any other components r

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50434656 ↗
• MalfunctionJun 26, 2026Thermal Decomposition of Device

  A Biomedical Technician (BMT) reported to Technical Support that a 2008T machine experienced fails multiple self-tests including TMP high soft, act temp high, act temp low, temp high soft, and conductivity high. The BMT stated the temperature was 37.1°C and did not change during the self-test. Customer replaced the actuator-test board. Customer placed the device in self-test twice during the call. The BMT stated the device was now functioning normally and passes the self-test. Upon follow-up, the BMT stated that it was a short electrical issue with the bicarb pump. The BMT was not able to provide more information. No photos were available and no parts were returned for evaluation. The BMT confirmed there was no patient involvement, harm, or adverse events associated with the reported issue. The machine is back in service.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25643990 ↗
• MalfunctionMay 25, 2026Thermal Decomposition of Device

  A BIOMEDICAL TECHNICIAN (BMT) REPORTED TO TECHNICAL SUPPORT THAT A 2008T MACHINE POWER PLUG WAS DISCOLORED. MACHINE ALSO EXPERIENCED AN AUDIBLE ALARM WITH A BUZZING NOISE. THE BIOMEDICAL TECHNICIAN STATED THAT THE SPEAKER WAS REPLACED TO RESOLVE THE NOISE ISSUE AND POWER CABLE REPLACED TO RESOLVE PHYSICAL DAMAGE. THE MACHINE IS BACK IN SERVICE. IT WAS CONFIRMED THERE WAS NO PATIENT INVOLVEMENT, NO HARM OR ADVERSE EVENTS REPORTED WITH THIS INCIDENT. FAULTY PART WAS DISCARDED.THE POWER CABLE ASSEMBLY WAS RETURNED FOR INVESTIGATION AND SIGNS OF THERMAL DAMAGE IN THE POWER PLUG ON THE HOT PHASE WERE FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25271150 ↗
• MalfunctionApr 29, 2026Thermal Decomposition of Device

  A FRESENIUS FIELD SERVICE TECHNICIAN (FST) WAS CALLED ONSITE TO REPAIR A 2008T MACHINE DUE TO USB FRONT PORT WAS NOT WORKING, THE CUSTOMER CAN'T ACTIVATE THE CLIC DEVICE. THE FST REPLACED THE FRONT USB PORT TO RESOLVE THE REPORTED ISSUE. DURING INSPECTION, IT WAS FOUND THAT THE USB CONNECTION CAUSED DAMAGE TO THE FUNCTION BOARD; THEREFORE, THE FUNCTION BOARD WAS REPLACED TO FIX THE PROBLEM. THE DEFECTIVE FUNCTION BOARD WAS RETURNED FOR EVALUATION AND WAS DETERMINED TO HAVE A SHORT ON THE CONTROL COIL RESULTING IN THERMAL DECOMPOSITION. MACHINE FUNCTIONAL TESTS WERE COMPLETED AND IS BACK ON SERVICE. THERE WAS NO PATIENT INVOLVED, NO HARM OR ADVERSE EVENTS REPORTED WITH THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25037586 ↗
• MalfunctionApr 28, 2026Fluid/Blood Leak

  A USER FACILITY BIOMEDICAL TECHNICIAN (BMT) REPORTED A HEMODIALYSIS (HD) MACHINE HAD A POSITIVE BLOOD LEAK INCIDENT. THE BMT STATED THE FLOOR STAFF CLAIMED THE MACHINE NEVER ALARMED FOR BLOOD LEAK. THE BMT ALSO STATED BLOOD WAS OBSERVED IN THE FLOW INDICATOR, BUT NOT DOWNSTREAM FROM THE DIALYZER. THE BMT WAS NOT CERTAIN OF DIALYSATE FLOW RATES AT THE TIME OR IF THE MACHINE WAS IN SEQUENTIAL OR NOT. UPON FOLLOW-UP, THE BMT STATED A PATIENT WAS DIALYZING ON THE MACHINE AND THE FLOOR STAFF EXPRESSED BLOOD WAS OBSERVED IN THE BLUE HANSON LINE DURING A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE BMT INDICATED THE FLOOR STAFF CLAIMED THE MACHINE DID NOT ALARM APPROPRIATELY WITH A BLOOD LEAK ALERT. THE BMT STATED BLOOD WAS REPORTEDLY OBSERVED IN THE FLOW INDICATOR BUT WAS NOT OBSERVED DOWNSTREAM OF THE DIALYZER. THE BMT WAS NOT PROVIDED WITH ANY INFORMATION REGARDING WHETHER A DIALYZER BLOOD LEAK OCCURRED AND WAS INSTRUCTED TO CHECK OPERATION OF THE BLOOD LEAK DETECTOR. THE BMT WAS UNABLE TO PROVIDE ANY PATIENT DEMOGRAPHICS OR TREATMENT PRESCRIPTION SETTINGS INCLUDING DIALYSATE FLOW RATES AT THE TIME OF TREATMENT. THE BMT STATED AS FAR AS HE WAS AWARE, THERE WAS NO IMPACT TO THE PATIENT AN

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25015853 ↗
• MalfunctionApr 22, 2026Fluid/Blood Leak

  A USER FACILITY'S BIOMEDICAL TECHNICIAN (BMT) REPORTED THAT A 2008T HEMODIALYSIS (HD) MACHINE HAD BLOOD THAT ENTERED THE VENOUS HANSEN CAUSING THE FLOW INDICATOR TO LEAK. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) IS UNKNOWN. NO PATIENT SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED DUE TO THIS EVENT. A FRESENIUS FIELD SERVICE TECHNICIAN (FST) WAS CALLED ONSITE AND REPLACED THE FLOW INDICATOR TO RESOLVE THE ISSUE. MACHINE FUNCTIONAL TESTS WERE COMPLETED AND PASSED ONSITE AFTER REPAIR. 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: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24955521 ↗
• MalfunctionApr 22, 2026Thermal Decomposition of Device

  A USER FACILITY BIOMEDICAL TECHNICIAN (BMT) REPORTED THEY HAD BEEN EXPERIENCING AN ISSUE WHERE THE CRIT-LINE WILL NOT POWER UP. THE BMT PREVIOUSLY SOLVED THE ISSUE BY REPLACING THE FRONT PORT USB AND/OR THE FUNCTIONAL BOARD, BUT THE ISSUE RETURNED WITHIN 3 MONTHS TO A YEAR. THE BMT HAD REPLACED THE FUNCTIONAL BOARD FOUR TIMES AND THE USB TWO TIMES. THE BMT WAS ADVISED THEIR POWER SUPPLY OR MOTHER BOARD IS SHORTING OUT THEIR DAUGHTER COMPONENTS. ADVISED THE CUSTOMER TO REPLACE THE POWER SUPPLY FIRST AND ONLY ATTEMPT THE MOTHER BOARD AFTER AND IF THE ISSUE PERSISTS TO PREVENT BURNING A NEW MOTHERBOARD. THERE WAS NO PATIENT INVOLVEMENT OR INJURY NOTED AT INTAKE. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT RECEIVED TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24949946 ↗
• MalfunctionApr 14, 2026Thermal Decomposition of Device; Arcing

  It was reported to Fresnius that the power cord on the 2008T machine sustained damage. Upon follow-up, the user facility biomedical technician (biomed) confirmed that the power cord sustained thermal damage. The power cord appeared blackened and there was darkness inside the plug. The biomed determined the damaged power cord was the result of arcing. The reported issue was identified during a routine check at the end of the day. There was no harm to any patients or individuals as a result of this issue. There was no smoke, spark, or flame observed. No additional thermal damage was identified and the reported issue did not cause extensive damage to the machine. There was no issue identified with the power outlet. The machine has approximately 4,204 operating hours and the plug is original to the machine. A replacement plug was ordered to resolve the reported issue. The replacement part had not arrived at the time of follow-up. The machine remained out of service pending repair. The biomed stated the part would be replaced without assistance from Fresenius. No parts were reported to be returned to the manufacturer for physical evaluation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24875079 ↗
• MalfunctionApr 13, 2026Thermal Decomposition of Device

  The Biomedical Technician (biomed) reported to Fresenius Technical Services that the power plug on the 2008T machine was blackened. No smoke, spark, flame, or arcing was observed. The power plug is original to the machine. The machine has approximately 4,204 operating hours. The biomed stated that the reported issue was identified during a routine check. There was no harm to any patients or individuals as a result of this malfunction. No additional thermal damage was identified and the reported issue did not cause extensive damage to the machine. No issues were identified with the hospital grade ground-fault circuit interrupter (GFCI) outlet. A replacement plug was ordered to resolve the reported issue. The replacement part had not arrived at the time of follow-up. The machine remained out of service pending repair. No parts were reported to be returned to the manufacturer for physical evaluation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24864982 ↗
• MalfunctionApr 13, 2026Melted; Smoking

  THE BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS THAT THE 2008T MACHINE WAS UNDERGOING PRE-TREATMENT TESTING WHEN SMOKE WAS OBSERVED FROM THE HOSPITAL GRADE GROUND-FAULT CIRCUIT INTERRUPTER (GFCI) OUTLET. NO SMOKE DETECTORS WERE TRIGGERED AND A FIRE EXTINGUISHER WAS NOT REQUIRED TO ADDRESS THE SMOKE. THE POWER PLUG WAS PULLED AND THE MACHINE WAS TRANSPORTED TO THE BIOMED¿S ROOM. UPON EVALUATION, THE POWER PLUG APPEARED MELTED. THE MACHINE HAS APPROXIMATELY 4,302 OPERATING HOURS. THE POWER PLUG IS ORIGINAL TO THE MACHINE. NO ADDITIONAL THERMAL DAMAGE WAS IDENTIFIED AND THE REPORTED ISSUE DID NOT CAUSE EXTENSIVE DAMAGE TO THE MACHINE. A REPLACEMENT POWER PLUG WAS ORDERED BUT HAD NOT BEEN RECEIVED AT THE TIME OF FOLLOW-UP. THE BIOMED STATED THEY WOULD REPLACE THE PART WITHOUT REQUIRING ASSISTANCE. THE MACHINE REMAINS OUT OF SERVICE PENDING REPAIR. THE POWER OUTLET WAS REPLACED BY THE BIOMED. THERE WAS NO HARM TO ANY PATIENTS OR INDIVIDUALS AS A RESULT OF THIS MALFUNCTION. NO PARTS WERE REPORTED TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24864180 ↗
• MalfunctionMar 25, 2026Thermal Decomposition of Device; Melted

  A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS TECHNICAL SUPPORT THAT A 2008T HEMODIALYSIS (HD) MACHINE DISPLAYED AN 'E.08' ALARM WITH AN 'ART. BP NO COMM' MESSAGE DURING THE SELECT PROGRAM SCREEN. ADDITIONAL DETAILS WERE PROVIDED UPON FOLLOW-UP WITH THE BIOMED. THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE EVENT. THE BIOMED FIRST TRIED REPLACING THE LP955 BOARD, BUT THIS DID NOT RESOLVE THE ISSUE. DURING TROUBLESHOOTING, THE BIOMED FOUND THERMAL DAMAGE ON THE BLOOD PUMP MOTOR. NO OTHER PARTS WERE FOUND TO BE DAMAGED. THE BIOMED SAID WHEN THEY OPENED UP WHERE THE MOTOR BRUSHES ARE, THEY NOTICED THAT IT WAS PACKED FULL OF BLACK DUST. AFTER CLEARING THE DEBRIS, THE BIOMED COULD SEE THAT THE WHITE PLASTIC AROUND THE MOTOR BRUSHES WAS BLACKENED AND MELTED. NO BURNING SMELL WAS NOTED. THE BIOMED CONFIRMED THERE WERE NO SIGNS OF SMOKE, SPARKS, OR FLAMES. THE BIOMED REPLACED THE BLOOD PUMP MOTOR AND THE ALARMS WENT AWAY. THE BLOOD PUMP MOTOR WAS REPORTED TO BE THE ORIGINAL FRESENIUS PART ON THE MACHINE. THE BIOMED CONFIRMED THE MACHINE WAS PLUGGED INTO A HOSPITAL GRADE GROUND-FAULT CIRCUIT INTERRUPTER (GFCI) OUTLET AND HAD NO PAST PROBLEMS WITH FAILING THE ELE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24683558 ↗
• MalfunctionFeb 16, 2026Thermal Decomposition of Device

  A USER FACILITY'S BIOMEDICAL TECHNICIAN (BMT) REPORTED THAT A 2008T HEMODIALYSIS (HD) MACHINE TRIPPED THE GROUND FAULT CIRCUIT INTERRUPTER (GFCI) DURING RINSE MODE. 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 BMT REPLACED THE POWER SUPPLY ASSEMBLY AND STATED THAT THE ORIGINAL POWER CONTROL BOARD HAD SIGNS OF BURNING/CHARRING. IT IS UNKNOWN IF THE COMPLAINT DEVICE IS AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. MULTIPLE ATTEMPTS HAVE BEEN MADE TO CONTACT THE CUSTOMER TO OBTAIN ADDITIONAL INFORMATION RELATED TO THE REPORTED EVENT. AT THIS TIME, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24344349 ↗
• DeathFeb 6, 2026Adverse Event Without Identified Device or Use Problem

  THE BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS TECHNICAL SERVICES THAT A HEMODIALYSIS PATIENT WAS IN TREATMENT ON (B)(6) 2026 UTILIZING THE FRESENIUS 2008T HEMODIALYSIS MACHINE WHEN THEY BECAME RESTLESS. THE PATIENT WAS LAID FLAT. THE PATIENT RELIEVED THEMSELVES DURING THE TREATMENT AND THE STAFF PROCEEDED TO CLEAN THE PATIENT. THE PATIENT THEN COMPLAINED AND WANTED TO SIT UP. THE PATIENT STOPPED TALKING/RESPONDING AND THEN CODED. RESUSCITATION WAS UNSUCCESSFUL. NO ALARMS OR ISSUES WITH THE 2008T MACHINE WERE NOTED DURING TREATMENT. IT WAS REQUESTED THAT THE DEVICE BE INSPECTED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE UNSUCCESSFUL. NO FURTHER DETAILS COULD BE GATHERED.

  Patient problems: Cardiac Arrest

  MAUDE report 24277493 ↗
• MalfunctionFeb 5, 2026Fluid/Blood Leak

  A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED THAT A BLOOD PUMP ROTOR ON A 2008T HEMODIALYSIS (HD) MACHINE CUT THE TUBING OF A COMBISET BLOODLINE DURING A PATIENT¿S HD TREATMENT. ADDITIONAL DETAILS WERE PROVIDED UPON FOLLOW-UP WITH THE BIOMED AND A REGISTERED NURSE (RN) FAMILIAR WITH THE EVENT. APPROXIMATELY ONE HOUR AFTER THE START OF TREATMENT, THE RN NOTICED A CLICKING NOISE COMING FROM THE MACHINE. THEY TRACED THE NOISE TO THE BLOOD PUMP ROTOR. THE RN THEN NOTICED A SMALL AMOUNT OF BLOOD LEAKING FROM THE BLOOD PUMP. THERE WERE NO MACHINE ALARMS THAT OCCURRED. THE RN STOPPED THE BLOOD PUMP AND THE PATIENT WAS DISCONNECTED FROM THE MACHINE. THE RN DID NOT INSPECT THE BLOODLINE FOLLOWING THE EVENT. THEY SAID THEY FOCUSED THEIR ATTENTION ON THE SAFETY OF THE PATIENT. THE RN SAID THERE WAS NO VISIBLE DAMAGE NOTED ON THE LINES PRIOR TO TREATMENT INITIATION. THE PATIENT'S BLOOD WAS NOT RETURNED. ESTIMATED BLOOD LOSS (EBL) DUE TO THE EVENT WAS REPORTED TO BE 200 ML. THE PATIENT WAS ABLE TO COMPLETE THEIR TREATMENT AFTER BEING RE-SETUP WITH NEW SUPPLIES ON A DIFFERENT MACHINE. THE RN CONFIRMED THERE WAS NO PATIENT SERIOUS INJURY, NO ADVERSE EFFECTS WERE EXPERIENCED, AND NO MED

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24273012 ↗
• MalfunctionJan 26, 2026Thermal Decomposition of Device; Smoking

  A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED THAT A 2008T HEMODIALYSIS (HD) MACHINE POWERED DOWN DURING CHEMICAL UPTAKE AND A SMALL CURL OF SMOKE WAS EMITTED FROM THE POWER SUPPLY. ADDITIONAL DETAILS WERE PROVIDED UPON FOLLOW-UP WITH THE BIOMED. THE BIOMED REPORTED THAT A BURNING SMELL WAS PRESENT. THE SMOKE DETECTOR DID NOT GO OFF. THERE WERE NO SPARKS OR FLAMES. DURING THE MACHINE INSPECTION, THE BIOMED FOUND CAPACITOR 10 ON THE POWER CONTROL BOARD TO BE COMPLETELY CHARRED (OR BURNT). TO RESOLVE THE ISSUE, THE BIOMED REPLACED THE ENTIRE POWER SUPPLY UNIT. THE BIOMED SAID THERE WERE 330 HOURS ON THE MACHINE. THE POWER SUPPLY (AND THE POWER CONTROL BOARD INSIDE OF IT) WERE CONFIRMED TO BE ORIGINAL FRESENIUS PARTS. 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. THE MACHINE WAS RETURNED TO SERVICE UPON COMPLETION OF THE REPAIR. IT WAS CONFIRMED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE EVENT. THE BIOMED SAID THE OLD POWER SUPPLY UNIT WOULD BE SENT BACK FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24185508 ↗
• MalfunctionJan 15, 2026Thermal Decomposition of Device

  THE BIOMEDICAL TECHNICIAN (BIOMED) FOR A USER FACILITY REPORTED TO FRESENIUS TECHNICAL SERVICES THAT AN OUT OF BOX FAILURE OCCURRED WITH THE 2008T MACHINE ACTUATOR BOARD. DATA COULD NOT BE SENT TO THE ACTUATOR BOARD. FRESENIUS ADVISED THAT THE PART WOULD BE REPLACED VIA EXTENDED PARTS WARRANTY. NO PATIENT INVOLVEMENT OR ADVERSE EVENT WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED HOWEVER A RESPONSE WAS NOT RECEIVED. THE PART WAS RETURNED TO THE MANUFACTURER. UPON EVALUATION, THERMAL DECOMPOSITION WAS IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24078864 ↗
• MalfunctionJan 14, 2026Fluid/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 DURING A PATIENT'S HD TREATMENT RESULTING IN BLOOD LOSS. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) IS UNKNOWN. IT IS UNKNOWN IF THERE WAS ANY PATIENT SERIOUS INJURY OR ADVERSE EVENT. UPON FOLLOW UP, THE BMT SAID THAT A FRESENIUS FIELD SERVICE TECHNICIAN (FST) WAS CALLED ONSITE AND REPLACED THE BLOOD PUMP MODULE TO RESOLVE THE ISSUE. MACHINE FUNCTIONAL TESTS WERE COMPLETED AND PASSED ONSITE AFTER REPAIR. THE COMPLAINT SAMPLE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL 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: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24069757 ↗
• MalfunctionDec 26, 2025Thermal Decomposition of Device; Thermal Decomposition of Device

  A USER FACILITY BIOMEDICAL TECHNICIAN (BMT) REPORTED THE DEAERATION MOTOR SEIZED AND BURNED UP (MELTING DAMAGE) DURING DIALYSIS TREATMENT MODE. THERE WERE NO ADVERSE REACTIONS WITH THE PATIENT AND THE PATIENT COMPLETED TREATMENT ON ANOTHER DEVICE. NO BLOOD LOSS WAS REPORTED. THE BMT STATED THE DEAERATION MOTOR HAD BEEN RUNNING FOR ABOUT 24,000 MACHINE HOURS. THE RESULTING MACHINE SYMPTOMS WERE A LOW FLOW ERROR AND A BIBAG: PRESSURE TOO LOW ALARM. THE MOTOR WAS REPLACED AND THE MACHINE WAS RUNNING WITH NO FURTHER ISSUES. UPON FOLLOW-UP, THE BMT STATED THE DEAERATION MOTOR WAS REPLACED TO RESOLVE THE REPORTED ISSUE. THE MACHINE IS BACK IN SERVICE. IT IS CONFIRMED THERE WAS PATIENT INVOLVEMENT WITH THIS ISSUE AND THE PATIENT WAS SWITCHED ONTO ANOTHER MACHINE TO COMPLETE TREATMENT AND THERE WAS NO HARM OR ADVERSE EVENT REPORTED. THE BMT STATED A BURNING SMELL WAS NOTED AND THERE WERE NO SIGNS OF ANY SMOKE, SPARKS, OR FLAMES, AND NO OTHER COMPONENTS WERE NOTED TO HAVE BEEN BURNT OR CHARRED. THE BMT STATED NO OTHER COMPONENTS WERE OBSERVED TO BE DAMAGED. IT WAS CONFIRMED THE MACHINE WAS PLUGGED INTO A HOSPITAL GRADE GROUND-FAULT CIRCUIT INTERRUPTER (GFCI) OUTLET. THE BMT STATED THE MACHI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23898433 ↗
• DeathDec 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A BIOMEDICAL TECHNICIAN CONTACTED FRESENIUS TECHNICAL SUPPORT TO REPORT AN ADVERSE EVENT OF A PATIENT WHILE UTILIZING THE 2008T HEMODIALYSIS (HD) MACHINE. THE PATIENT LATER PASSED AWAY OUTSIDE THE FACILITY. THE BIOMED REPORTED THAT DURING VERIFICATION TESTING OF THE MACHINE, THE ULTRAFILTRATION (UF) VOLUME WAS OUT OF SPECIFICATION. AFTER 24 STROKES OF THE UF PUMP, 24.3ML WAS REMOVED FROM THE BURETTE. ADDITIONAL INFORMATION WAS OBTAINED THROUGH FOLLOW-UP WITH THE CLINICAL MANAGER (CM). THE PATIENT HAD BEEN INITIATED ON HD APPROXIMATELY A WEEK AND A HALF PRIOR TO THE EVENT. THE PATIENT HAD A BLADDER TUMOR REMOVED ON (B)(6) 2025 WHICH RESULTED IN KIDNEY FAILURE. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2025. THE PATIENT¿S FIRST HD TREATMENT AT THE FACILITY WAS (B)(6) 2025. THE PATIENT WAS INITIATED ON TREATMENT ON (B)(6) 2025 UTILIZING THE 2008T MACHINE. THE TREATMENT STARTED AT 0748. THE PATIENT¿S BLOOD PRESSURE (BP) WAS REPORTEDLY STABLE THROUGHOUT THE FIRST TWO HOURS OF TREATMENT. THE SYSTOLIC PRESSURES WERE 140S, 120S, AND 101 (TIMES NOT PROVIDED). THE LAST REGISTERED BP SHOWED SYSTOLIC PRESSURE OF 122 AT 0930. AT 0930 THE NURSE DID A 30-MINUTE CHECK ON THE PATIENT,

  Patient problems: Cardiac Arrest

  MAUDE report 23832618 ↗
• MalfunctionDec 2, 2025Obstruction of Flow; Obstruction of Flow

  A USER FACILITY'S NURSE MANAGER (RN) REPORTED THAT A 2008T HEMODIALYSIS (HD) MACHINE DISPLAYED A TMP ALARM AND EXPERIENCED BLOOD THAT BACKED UP TO THE VENOUS TRANSDUCER PROTECTOR DURING A PATIENT'S HD TREATMENT. IT WAS REPORTED THAT THE MACHINE CLOTTED ON THE VENOUS SIDE RESULTING IN BLOOD LOSS. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) IS UNKNOWN. IT IS UNKNOWN IF THERE WAS ANY PATIENT SERIOUS INJURY OR ADVERSE EVENT. THE PATIENT WAS RESTARTED ON THE SAME MACHINE WITH NEW SUPPLIES, BUT THE TMP ALARMS PERSISTED. TREATMENT WAS TERMINATED EARLY AS A RESULT. THE MACHINE WAS REMOVED FROM SERVICE FOLLOWING THE INCIDENT. A FRESENIUS FIELD SERVICE TECHNICIAN (FST) ORDERED A NEW LEVEL DETECTOR FOR THE CUSTOMER. THE BIOMEDICAL TECHNICIAN (BMT) RECEIVED THE NEW LEVEL DETECTOR AND INSTALLED IT TO RESOLVE THE ISSUE. THE COMPLAINT DEVICE IS AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. MULTIPLE ATTEMPTS HAVE BEEN MADE TO CONTACT THE CUSTOMER TO OBTAIN ADDITIONAL INFORMATION RELATED TO THE REPORTED EVENT. AT THIS TIME, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23697068 ↗
• MalfunctionDec 2, 2025Obstruction of Flow; Obstruction of Flow

  A USER FACILITY'S NURSE MANAGER (RN) REPORTED THAT A 2008T HEMODIALYSIS (HD) MACHINE DISPLAYED A TMP ALARM AND EXPERIENCED BLOOD THAT BACKED UP TO THE VENOUS TRANSDUCER PROTECTOR DURING A PATIENT'S HD TREATMENT. IT WAS REPORTED THAT THE MACHINE CLOTTED ON THE VENOUS SIDE RESULTING IN BLOOD LOSS. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) IS UNKNOWN. IT IS UNKNOWN IF THERE WAS ANY PATIENT SERIOUS INJURY OR ADVERSE EVENT. THE PATIENT WAS RESTARTED ON THE SAME MACHINE WITH NEW SUPPLIES, BUT THE TMP ALARMS PERSISTED. TREATMENT WAS TERMINATED EARLY AS A RESULT. THE MACHINE WAS REMOVED FROM SERVICE FOLLOWING THE INCIDENT. A FRESENIUS FIELD SERVICE TECHNICIAN (FST) ORDERED A NEW LEVEL DETECTOR FOR THE CUSTOMER. THE BIOMEDICAL TECHNICIAN (BMT) RECEIVED THE NEW LEVEL DETECTOR AND INSTALLED IT TO RESOLVE THE ISSUE. THE COMPLAINT DEVICE IS AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. MULTIPLE ATTEMPTS HAVE BEEN MADE TO CONTACT THE CUSTOMER TO OBTAIN ADDITIONAL INFORMATION RELATED TO THE REPORTED EVENT. AT THIS TIME, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23697060 ↗
• MalfunctionDec 2, 2025Obstruction of Flow; Obstruction of Flow

  A USER FACILITY'S NURSE MANAGER (RN) REPORTED THAT A 2008T HEMODIALYSIS (HD) MACHINE DISPLAYED A TRANS MEMBRANE PRESSURE (TMP) ALARM AND EXPERIENCED BLOOD THAT BACKED UP TO THE VENOUS TRANSDUCER PROTECTOR DURING A PATIENT'S HD TREATMENT. IT WAS REPORTED THAT THE MACHINE CLOTTED ON THE VENOUS SIDE RESULTING IN BLOOD LOSS. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) IS UNKNOWN. IT IS UNKNOWN IF THERE WAS ANY PATIENT SERIOUS INJURY OR ADVERSE EVENT. THE PATIENT WAS RESTARTED ON THE SAME MACHINE WITH NEW SUPPLIES, BUT THE TMP ALARMS PERSISTED. TREATMENT WAS TERMINATED EARLY AS A RESULT. THE MACHINE WAS REMOVED FROM SERVICE FOLLOWING THE INCIDENT. A FRESENIUS FIELD SERVICE TECHNICIAN (FST) ORDERED A NEW LEVEL DETECTOR FOR THE CUSTOMER. THE BIOMEDICAL TECHNICIAN (BMT) RECEIVED THE NEW LEVEL DETECTOR AND INSTALLED IT TO RESOLVE THE ISSUE. THE COMPLAINT DEVICE IS AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. MULTIPLE ATTEMPTS HAVE BEEN MADE TO CONTACT THE CUSTOMER TO OBTAIN ADDITIONAL INFORMATION RELATED TO THE REPORTED EVENT. AT THIS TIME, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23696927 ↗
• MalfunctionNov 11, 2025Inadequate Ultra Filtration; Inadequate Ultra Filtration

  A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS TECHNICAL SUPPORT (TS) THAT THIS 2008T HEMODIALYSIS (HD) MACHINE WAS PULLED FROM SERVICE BECAUSE A PATIENT CAME OFF THE MACHINE AT A HIGHER WEIGHT THAN WHEN THE TREATMENT WAS STARTED. THE BIOMED WAS IN THE BEGINNING STAGES OF INVESTIGATING AND NEEDED ASSISTANCE FINDING THE DOCUMENTATION FOR ULTRAFILTRATION (UF) PROBLEM IDENTIFICATION. TS HELPED THE BIOMED FIND BOTH THE UF CHECKLIST AND INSTRUCTIONS. THE BIOMED WAS SUSPECTING OPERATOR ERROR, BUT THIS COULD NOT BE CONFIRMED. 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 23528521 ↗

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-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-1867-2024 · Apr 17, 2024 · Open, Classified
  2008T BlueStar Hemodialysis Machine, Model 191124 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A.
• 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-0032-2024 · Sep 6, 2023 · Open, Classified
  2008T HD SYS. CDX BLUESTAR
• Z-0035-2024 · Sep 6, 2023 · Open, Classified
  2008T HD SYS. W/O CDX W/BIBAG BLUESTAR
• 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-0028-2024 · Sep 6, 2023 · Open, Classified
  2008T Hemodialysis SYS, with CDX
• 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-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-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
• Z-3194-2018 · Jul 13, 2018 · Terminated
  2008T HEMODIALYSIS SYS, WITH CDX, Part Number 190713, Applicable only with 2008T BlueStar Premium Upgrade Kit, Part Number 191138 Product Usage: Indicated for acute and chronic di

…and 1 more.