2008T BlueStar Hemodialysis Machine 191130Recalls & reported problems

Summary

The FDA's MAUDE database contains 272 adverse event reports that list this exact device (DI 00840861102112), received between Aug 26, 2019 and Sep 30, 2026 — classified as 7 deaths, 12 injuries, 253 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (146 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. 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-1870-2024 · Root cause: Device Design · Recall details · FDA record ↗

4. Sep 6, 2023Class IOpen, Classified

   Potential PCBA leaching from tubing of hemodialysis machines.

   Z-0035-2024 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 272 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Thermal Decomposition of Device

  A user facility's biomedical technician (BMT) reported that a 2008T Hemodialysis (HD) Machine showed signs of burnt and charred wires. 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 50951832 ↗
• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Cardiac Arrest

  MAUDE report 50918636 ↗
• DeathSep 17, 2026Adverse Event Without Identified Device or Use Problem

  On 31/Aug/2026, Fresenius Medical Care (FME) became aware this patient with renal failure (RF) on hemodialysis (HD) utilizing a 2008T Hemodialysis System for renal replacement therapy (RRT) expired while undergoing HD on (b)(6) 2026. Follow-up with the clinical charge nurse (CCN) revealed the 2008T Hemodialysis System evaluation took place on (b)(6) 2026 and it was returned to service on (b)(6) 2026 after disinfection. The CCN stated there were no adverse findings during the evaluation, nor did the 2008T Hemodialysis System require any repair, aside from calibrating the ultrafiltration (UF) pump. The patient was in critical condition and had already suffered several cardiac arrests (specifics not provided) prior to attempting ¿urgent start¿ HD. The CCN stated there was no concern a FME device(s) and/or product(s) caused or contributed to the patients cardiac arrest or death. The 2008T Hemodialysis System was sequestered following the serious adverse events. On 8/Sep/2026, an FME field service technician (FST) was dispatched to perform post-event functional compliance testing. The device passed all functional compliance testing (e.g., self-tests, conductivity, temperature, pH, simul

  Patient problems: Insufficient Information

  MAUDE report 50808534 ↗
• MalfunctionSep 16, 2026Thermal Decomposition of Device

  A user facility's biomedical technician (BMT) reported that a 2008T Hemodialysis (HD) Machine¿s heparin pump was not working. During repair the BMT observed arcing and discoloration marks on the 8-pin component of the distribution board. The BMT reported that there was no melting, burning smell, smoke, spark, or flame observed. The machine has not had any past problems with failing the electrical leakage test and there was no damage observed to any other components. The machine has approximately 2,200 hours and is plugged into a hospital grade ground-fault circuit interrupter (GFCI) outlet. A FME Field Service Technician (FST) was called onsite and confirmed the arcing as well as discoloration on the heating block and signs that the wires had loosened causing a buildup of heat. The FST replaced the distribution board to resolve the issues. Machine functional tests were completed and passed onsite after repair. There was blood loss, patient serious injury or adverse events reported. The complaint device is not available to be returned to the manufacturer for evaluation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50789341 ↗
• MalfunctionSep 4, 2026Thermal Decomposition of Device

  A Fresenius Field Service Technician (FST) was called on-site to service a 2008T hemodialysis (HD) machine that would not power up. The FST found a burnt spot on the motherboard, which caused chain reaction of multiple boards to be damaged. The FST replaced the Power control board, main power cable, motherboard, and UI board for power issue. The FST replaced the actuator board for new found issue, ACT Fail Error with troubleshooting power issue. The FST replaced the Sensor BD fo Cond Offset Reference Failure and would not let the FST calibrate the conductivity cells until the sensor board was replaced. The FST replaced the concentrate connector and threaded end because they were fused together. The FST also used a one-year PM kit to replace o-rings, circlip and spacer to complete concentrate connector. There was no patient involvement or patient injury noted. Additional information was requested but was not received to date.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50611914 ↗
• MalfunctionJul 20, 2026Thermal Decomposition of Device

  A user facility's biomedical technician (BMT) reported that a 2008T Hemodialysis (HD) Machine emitted a burning smell during cleaning mode. A Fresenius Field Service Technician (FST) was called onsite and ordered a UI/ MICS board for the customer. Upon follow up, the BMT said that the user interface (UI) board and its cable had a burning smell and the UI/ MICS board was 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 remains out of service as they are waiting for a part to arrive. 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 25876231 ↗
• MalfunctionJun 22, 2026Thermal Decomposition of Device

  A user facility reported that the machine would not complete heat disinfection. The heater rod was replaced as the heater rod was discolored. Upon follow up, it was reported that there was thermal damage on the heater rod. The heater rod was replaced and the machine was able to go through heat disinfection. There was no patient involvement as the reported issue was noted during heat disinfection. The heater rod was discarded.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25579898 ↗
• DeathMay 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS UNKNOWN PATIENT WITH RENAL FAILURE (RF) ON HEMODIALYSIS (HD) UTILIZING A 2008T HEMODIALYSIS SYSTEM FOR RENAL REPLACEMENT THERAPY (RRT) SUFFERED A CARDIAC ARREST AFTER RECENTLY UNDERGOING HD THERAPY ON (B)(6) 2026. DURING FOLLOW-UP, THE CLINICAL CHARGE NURSE (CCN) REPORTED THE PATIENT WAS VERY UNSTABLE AND DID NOT TOLERATE HEMODIALYSIS (EXACT TIME NOT PROVIDED). THE CCN CONFIRMED THE PATIENT WAS DISCONNECTED WHEN THE CARDIAC ARREST OCCURRED; HOWEVER, THE MACHINE WAS SEQUESTERED PER POLICY AND PROCEDURE. THE PATIENT WAS RESUSCITATED; HOWEVER, THEY PASSED AWAY THE FOLLOWING DAY DUE TO THEIR CRITICAL CONDITION. THE CCN CONFIRMED THE 2008T HEMODIALYSIS SYSTEM WAS EVALUATED (PASSED) AND WAS RETURNED TO SERVICE ON (B)(6) 2026. THE SERIOUS ADVERSE EVENTS WERE REPORTEDLY UNRELATED TO ANY FRESENIUS DEVICE(S) AND/OR PRODUCT(S) MALFUNCTION OR DEFICIENCY. A FRESENIUS FIELD SERVICE TECHNICIAN (FST) WAS DISPATCHED TO PERFORM POST-EVENT FUNCTIONAL COMPLIANCE TESTING ON (B)(6) 2026. THE 2008T HEMODIALYSIS SYSTEM PASSED ALL FUNCTIONAL COMPLIANCE (E.G., SELF-TESTS, CONDUCTIVITY, TEMPERATURE, PH, ULTRAFILTRATION PUMP, FLUID REMOVAL) AND WAS RETURNED TO SERVICE THE SAME DAY.

  Patient problems: Cardiac Arrest

  MAUDE report 25278644 ↗
• DeathMay 4, 2026Adverse Event Without Identified Device or Use Problem

  On (b)(6) 2026, Fresenius became aware a patient with renal failure (RF) on hemodialysis (HD) utilizing a 2008T Hemodialysis System for renal replacement therapy (RRT) coded (cardiac arrest) fifteen minutes into HD therapy on (b)(6) 2026. It was also reported that the patient was asymptomatic prior to the serious adverse events. Follow-up with the clinical charge nurse (CCN) revealed that the 2008T Hemodialysis machine has been returned to service after being inspected by a Fresenius technician on (b)(6) 2026 (verified device passed all functional compliance testing following the serious adverse events). The CN reported there was no concern a Fresenius device(s) and/or product(s) caused or contributed to the patient¿s cardiac arrest or subsequent death. The patient was critically ill prior to dialysis and passed away later the same day. During follow-up, the CN reported the 2008T Hemodialysis System was pulled from service for assessment as per their policy and procedure, and not because a malfunction or deficiency was suspected. Based on the available information, the 2008T Hemodialysis System can be disassociated from having a causal or contributory role in the serious adverse ev

  Patient problems: Cardiac Arrest

  MAUDE report 25075400 ↗
• MalfunctionApr 29, 2026Inadequate Ultra Filtration

  A USER FACILITY BIOMEDICAL TECHNICIAN (BMT) REPORTED A HEMODIALYSIS (HD) PATIENT WAS NOT GETTING ENOUGH FLUID REMOVED ACCORDING TO STAFF. THE BMT STATED THE DEVICE HAD NEGATIVE FLOW ON AND NEGATIVE STABILIZE SELF-TEST FAILURES. THE BMT STATED THERE WAS ALSO A BIBAG PHT FAILED ALARM. THERE WAS PATIENT INVOLVEMENT WITH NO INJURY. THE BMT WAS ADVISED TO PERFORM THE INDUCED AIR LEAK TESTS AND INDUCED POSITIVE PRESSURE TESTS TO CHECK THE HYDRAULIC SYSTEM FOR LEAKS. THE BMT WAS ADVISED TO RECALIBRATE THE ULTRAFILTRATION (UF) PUMP AND TO PERFORM THE BIBAG PRESSURE CALIBRATION, THE REGULATOR PRESSURE CALIBRATION, AND PERFORM A FULL RINSE. THE BMT WAS ADVISED TO REPLACE THE DIALYSATE CONNECTOR O-RINGS, LOADING PRESSURE REGULATOR, FLOW PRESSURE REGULATOR, DEAERATION MOTOR, FLOW MOTOR. THE BMT WAS ADVISED TO REPLACE POSSIBLY THE UF PUMP, ACTUATOR-TEST BOARD, VALVE 24, VALVE 26, VALVE 43, DIALYSATE PRESSURE TRANSDUCER #9, OR CHAMBER FULL SWITCH ISSUES. UPON FOLLOW-UP, THE BMT STATED THE PATIENT WAS ABLE TO COMPLETE TREATMENT ON THE DAY OF THE REPORTED EVENT BUT DID NOT HAVE ENOUGH FLUID REMOVED DURING TREATMENT. THE PATIENT DID NOT DEVELOP ANY SYMPTOMS, ADVERSE EVENTS, INJURIES, OR REQUIRE MED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25029638 ↗
• InjuryApr 27, 2026Adverse Event Without Identified Device or Use Problem

  ON 13/APR/2026, IT WAS REPORTED THAT THIS PATIENT EXPERIENCED DECREASED BLOOD PRESSURE APPROXIMATELY 30 MINUTES INTO A HEMODIALYSIS TREATMENT UTILIZING THE FRESENIUS 2008 T MACHINE (SERIAL NUMBER (B)(6)). THE PATIENT¿S TREATMENT WAS ENDED. SUBSEQUENTLY, APPROXIMATELY 15 MINUTES LATER THE PATIENT CODED AFTER BEING TRANSPORTED TO A HOSPITAL ROOM. THERE WERE NO REPORTED ALLEGATIONS OF ANY ISSUES WITH THE OPERATION OF THE FRESENIUS 2008 T MACHINE. IN ADDITIONAL FOLLOW-UP, THE BIOMEDICAL TECHNICIAN ASSOCIATED WITH THE USER FACILITY CONFIRMED THAT THE PATIENT¿S TREATMENT WAS ENDED DUE TO LOW BLOOD PRESSURE DURING HEMODIALYSIS TREATMENT ON (B)(6) 2026. ADDITIONALLY, IT WAS CONFIRMED THAT THE PATIENT WAS NOT ON THE FRESENIUS HEMODIALYSIS MACHINE WHEN THE CODE OCCURRED. THE BIOMEDICAL TECHNICIAN HAD NO OTHER INFORMATION ABOUT THE PATIENT AVAILABLE AND COULD NOT PROVIDE MEDICAL CONTACT TO FOLLOW UP WITH. HOWEVER, THE BIOMEDICAL TECHNICIAN STATED THAT THERE IS NO ALLEGATION AGAINST THE FRESENIUS 2008 T MACHINE NOR ANY SUSPICION THAT THE MACHINE CAUSED THIS EVENT. THE BIOMEDICAL TECHNICIAN REQUESTED TO HAVE THE MACHINE EVALUATED (POST EVENT) BY HOSPITAL POLICY. CONTAINED IN THE FILE IS THE POS

  Patient problems: Cardiac Arrest; Low Blood Pressure/ Hypotension

  MAUDE report 25002171 ↗
• MalfunctionApr 17, 2026Thermal Decomposition of Device

  A Fresenius Field Service Technician (FST) was called on-site to repair a 2008T Hemodialysis (HD) machine that had an actuator board that kept blowing integrated circuit 12. The FST replaced the acid pump, bicarbonate pump, ultrafiltration (UF) pump, the actuator board and Negative Temperature Coefficient (NTC) #3 to resolve the issue. Machine functional tests were completed and passed onsite after repair. Upon follow-up, the user facility Biomedical Technician (BMT) stated the machine was repaired successfully by the FST. A patient was not connected to the machine at the time of the incident and there was no harm to any patients or individuals due to the reported event. The BMT stated the machine had approximately 15,500 hours at the time of the repair. The BMT indicated no components actually blew up but that the integrated circuit did apear burnt. There was no reported visible damage to any other components. The BMT stated there was no burning smell, smoke, spark, flame, or arcing related to the reported event. The BMT reported the acid pump, bicarb pump, uf pump and the actuator board were replaced by the FST which resolved the issue. Per BMT it was unknown which component was

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24918072 ↗
• MalfunctionMar 26, 2026Inadequate Ultra Filtration

  A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS TECHNICAL SUPPORT (TS) THAT THE ULTRAFILTRATION (UF) REMOVAL WAS TOO HIGH DURING TREATMENT MODE ON A 2008T HEMODIALYSIS (HD) SYSTEM. A FRESENIUS FIELD SERVICE TECHNICIAN (FST) WAS DISPATCHED TO THE FACILITY TO EVALUATE THE 2008T MACHINE. THE FST WAS UNABLE TO DUPLICATE THE REPORTED ISSUE, AND THE UF CALIBRATION WAS CONFIRMED TO BE WITHIN SPECIFICATION. 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 24706267 ↗
• DeathFeb 25, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS UNKNOWN PATIENT WITH RENAL FAILURE (RF) ON HEMODIALYSIS (HD) UTILIZING A 2008T HEMODIALYSIS SYSTEM FOR RENAL REPLACEMENT THERAPY (RRT) EXPERIENCED A CODE (CARDIAC ARREST) DURING TREATMENT ON (B)(6) 2026. FOLLOW-UP WITH THE INPATIENT CHARGE NURSE (ICN) CONFIRMED A PATIENT CODED WHILE UNDERGOING HEMODIALYSIS (HD) ON (B)(6) 2026 WHILE IN THE INTENSIVE CARE UNIT. THE ICN STATED THE PATIENT¿S CONDITION WAS ¿TENUOUS AT BEST¿ PRIOR TO INITIATING HD, AND THE FAMILY UNDERSTOOD ATTEMPTING HD WOULD BE ¿EXTREMELY RISKY.¿ THE ICN STATED SHE COULD NOT PROVIDE ANY MORE CLINICAL INFORMATION; HOWEVER, SHE REPORTED THE PATIENT PASSED AWAY THE FOLLOWING DAY ON (B)(6) 2026. PER THE ICN, THE SERIOUS ADVERSE EVENTS WERE NOT CAUSED BY ANY FRESENIUS PRODUCT(S), DRUG(S), AND/OR DEVICE(S) DEFICIENCY OR MALFUNCTION. THE 2008T HEMODIALYSIS SYSTEM WAS TAKEN OUT OF SERVICE, AND AN EVALUATION OF THE DEVICE WAS REQUESTED BY THE HOSPITAL. A FRESENIUS FIELD SERVICE TECHNICIAN (FST) WAS DISPATCHED TO PERFORM POST-EVENT FUNCTIONAL COMPLIANCE TESTING ON (B)(6) 2026, AND THE DEVICE PASSED ALL POST-EVENT COMPLIANCE AND ULTRAFILTRATION TESTING. THE ICN CONFIRMED THE 2008T HEMODIALYSIS SYSTEM WAS

  Patient problems: Cardiac Arrest

  MAUDE report 24443623 ↗
• MalfunctionFeb 18, 2026Thermal Decomposition of Device

  A USER FACILITY'S BIOMEDICAL TECHNICIAN (BMT) REPORTED THAT A 2008T HEMODIALYSIS (HD) MACHINE HAD LOW CONDUCTIVITY. DURING REPAIR, THE BMT FOUND THAT THE BICARBONATE PUMP RIBBON CABLE AND DISTRIBUTION BOARD COVER WERE SCORCHED DUE TO THE BICARBONATE PUMP OVERHEATING. 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. A FRESENIUS FIELD SERVICE TECHNICIAN (FST) WAS CALLED AND ORDERED A BICARBONATE PUMP FOR THE CUSTOMER. UPON FOLLOW UP, THE FST SAID THAT THERE WAS NO REPORT OF A BURNING SMELL. ADDITIONALLY, THERE WERE NO SIGNS OF SMOKE, SPARKS, OR FLAMES. TO RESOLVE THE ISSUE, THE CUSTOMER REPLACED THE BICARB PUMP. THE MACHINE WAS RETURNED TO SERVICE UPON COMPLETION OF THE REPAIR. THE COMPLAINT DEVICE WAS REPORTED TO BE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24376919 ↗
• MalfunctionFeb 18, 2026Thermal Decomposition of Device

  A USER FACILITY'S BIOMEDICAL TECHNICIAN (BMT) REPORTED THAT A 2008T HEMODIALYSIS (HD) MACHINE HAD LOW CONDUCTIVITY. DURING REPAIR, THE BMT FOUND THAT THE BICARBONATE PUMP RIBBON CABLE AND DISTRIBUTION BOARD COVER WERE SCORCHED DUE TO THE BICARBONATE PUMP OVERHEATING. 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 THE MACHINE HAS BEEN RETURNED TO SERVICE. 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 24376918 ↗
• MalfunctionFeb 18, 2026Thermal Decomposition of Device

  A USER FACILITY'S BIOMEDICAL TECHNICIAN (BMT) REPORTED THAT A 2008T HEMODIALYSIS (HD) MACHINE HAD LOW CONDUCTIVITY. DURING REPAIR, THE BMT FOUND THAT THE BICARBONATE PUMP RIBBON CABLE AND DISTRIBUTION BOARD COVER WERE SCORCHED DUE TO THE BICARBONATE PUMP OVERHEATING. 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. A FRESENIUS FIELD SERVICE TECHNICIAN (FST) WAS CALLED ONSITE AND REPLACED THE BICARBONATE PUMP TO RESOLVE THE ISSUE. MACHINE FUNCTIONAL TESTS WERE COMPLETED AND PASSED ONSITE AFTER REPAIR. UPON FOLLOW UP, THE FFST SAID THAT THERE WAS NO REPORT OF A BURNING SMELL. ADDITIONALLY, THERE WERE NO SIGNS OF SMOKE, SPARKS, OR FLAMES. THE COMPLAINT DEVICE WAS REPORTED TO BE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24376915 ↗
• MalfunctionFeb 18, 2026Thermal Decomposition of Device

  A USER FACILITY'S BIOMEDICAL TECHNICIAN (BMT) REPORTED THAT A 2008T HEMODIALYSIS (HD) MACHINE HAD LOW CONDUCTIVITY. DURING REPAIR, THE BMT FOUND THAT THE BICARBONATE PUMP RIBBON CABLE AND DISTRIBUTION BOARD COVER WERE SCORCHED DUE TO THE BICARBONATE PUMP OVERHEATING. 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. A FRESENIUS FIELD SERVICE TECHNICIAN (FST) ORDERED A BICARBONATE PUMP FOR THE CUSTOMER. UPON FOLLOW UP, THE FST SAID THAT THERE WAS NO REPORT OF A BURNING SMELL. ADDITIONALLY, THERE WERE NO SIGNS OF SMOKE, SPARKS, OR FLAMES. TO RESOLVE THE ISSUE, THE CUSTOMER REPLACED THE BICARB PUMP. THE MACHINE WAS RETURNED TO SERVICE UPON COMPLETION OF THE REPAIR. THE COMPLAINT DEVICE WAS REPORTED TO BE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24376913 ↗
• DeathFeb 11, 2026Adverse Event Without Identified Device or Use Problem

  A FACILITY BIOMEDICAL (BIOMED) TECHNICIAN REPORTED THAT A HEMODIALYSIS (HD) PATIENT WAS IN TREATMENT UTILIZING THE FRESENIUS 2008T HD MACHINE WHEN THEY CODED. THE BIOMED WAS REQUESTING AN ONSITE MACHINE EVALUATION. ADDITIONAL INFORMATION DOCUMENTED THAT THIS MALE PATIENT HAD BEEN ADMITTED TO THE HOSPITAL ON (B)(6) 2026 FOR AN INTERNAL BLEED AFTER A FALL. THE FALL WAS NOT RELATED TO DIALYSIS. THE PATIENT WAS IN HD TREATMENT ON (B)(6) 2026 CONNECTED TO THE 2008T MACHINE WHEN HIS CONDITION WAS DECLINING RAPIDLY (NO SPECIFIC INFORMATION PROVIDED). THE TREATMENT WAS STOPPED AND THE PATIENT WAS RINSED BACK. THE PATIENT WAS REMOVED FROM THE MACHINE TO ATTEMPT TO INCREASE HIS BLOOD PRESSURE. APPROXIMATELY 30 MINUTES AFTER BEING REMOVED FROM THE MACHINE, THE PATIENT WAS PRONOUNCED DECEASED. NO ADDITIONAL DETAILS WERE AVAILABLE PERTAINING TO MEDICAL INTERVENTIONS OR IF ANY RESUSCITATIVE EFFORTS WERE ADMINISTERED. THE DEATH WAS DETERMINED TO BE RELATED TO THE INTERNAL BLEED FROM THE FALL. THE REQUEST TO HAVE THE MACHINE EVALUATED WAS PER THEIR PROCEDURE. NO ISSUES WERE FOUND WITH THE MACHINE, AND THE MACHINE WAS PLACED BACK INTO SERVICE.

  Patient problems: Cardiac Arrest; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24315983 ↗
• InjuryNov 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS THAT THE PATIENT CODED DURING TREATMENT ON THE 2008T MACHINE. NO FURTHER INFORMATION REGARDING THE TREATMENT WAS AVAILABLE. THE BIOMED STATED THE PATIENT PASSED AWAY AT THE HOSPITAL TWO DAYS LATER. NO FURTHER DETAILS ABOUT THE PATIENT WERE PROVIDED DESPITE SEVERAL FOLLOW-UP ATTEMPTS. THE CUSTOMER REQUESTED (PER HOSPITAL POLICY) AN ONSITE VISIT FOR A DEVICE EVALUATION BY A FRESENIUS FIELD SERVICE TECHNICIAN (FST). THE FST DOCUMENTED IN THEIR SERVICE REPORT THAT THE FRESENIUS 2008T MACHINE PASSED ALL FUNCTIONAL TESTING.

  Patient problems: Cardiac Arrest

  MAUDE report 23582769 ↗
• MalfunctionNov 5, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE BIOMEDICAL TECHNICIAN (BIOMED) FOR A USER FACILITY REPORTED TO FRESENIUS TECHNICAL SERVICES THAT THE BLOODLINE TUBING WAS PUNCTURED BY THE 2008T MACHINE BLOOD PUMP ROTOR DURING THE PATIENT'S HEMODIALYSIS (HD) TREATMENT RESULTING IN BLOOD LOSS. THE PATIENT CARE TECHNICIAN (PCT) NOTIFIED THE BIOMED OF THE REPORTED ISSUE. DROPLETS WERE VISUALLY OBSERVED RUNNING DOWN THE FRONT OF THE MACHINE. THE PATIENT'S BLOOD WAS NOT RETURNED. THE PATIENT'S ESTIMATED BLOOD LOSS (EBL) WAS NOT PROVIDED. NO SERIOUS INJURY OR REQUIRED MEDICAL INTERVENTION RESULTED FROM THE REPORTED ISSUE. THE BIOMED ADVISED THE PCT TO TRANSFER THE PATIENT TO A DIFFERENT MACHINE WHERE TREATMENT WAS SUCCESSFULLY COMPLETED. THE MACHINE WAS REMOVED FROM SERVICE FOLLOWING THE REPORTED EVENT. A REPLACEMENT BLOOD PUMP ROTOR WAS ORDERED VIA GROUND SHIPPING. THE MACHINE REMAINS OUT OF SERVICE PENDING REPAIR. NO PARTS WERE REPORTED TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. ADDITIONAL INFORMATION WAS REQUESTED, HOWEVER A RESPONSE WAS NOT RECEIVED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23478417 ↗
• MalfunctionOct 20, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A CLINIC MANAGER REPORTED THAT THERE WAS A DIALYZER BLOOD LEAK DURING A HEMODIALYSIS (HD) TREATMENT. DURING TREATMENT IT WAS NOTICED THAT THE DIALYZER FIBERS WERE ONLY STREAKED WITH BLOOD, NOT FILLED COMPLETELY WITH BLOOD. IN A FOLLOW UP, THE NURSE REPORTED THAT THE BLOOD LEAK OCCURRED APPROXIMATELY 30 MIN PRIOR TO ENDING THE HD TREATMENT. THE NURSE EXPLAINED THAT THE LEAK WAS VISUALLY SEEN. THE BLOOD LEAK WAS DESCRIBED AS BEING AN INTERNAL BLOOD LEAK. A FRESENIUS 2008T MACHINE WAS BEING USED. THE MACHINE DID NOT ALARM WITH A BLOOD LEAK ALARM. BLOOD LEAK TEST STRIPS WERE NOT USED. FRESENIUS BLOODLINES WERE USED. THERE WAS NO DAMAGE NOTED ON THE DIALYZER. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS >100 ML. THERE WAS NO PATIENT INJURY, ADVERSE EVENT OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THIS EVENT. THE TREATMENT WAS CONSIDERED COMPLETED WHEN THE LEAK WAS NOTED. THE DEVICE IS AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23343039 ↗
• MalfunctionSep 29, 2025Thermal Decomposition of Device; Thermal Decomposition of Device

  A USER FACILITY¿S BIOMEDICAL TECHNICIAN (BMT) REPORTED THAT A 2008T HEMODIALYSIS (HD) HAD A LOW TEMPERATURE ISSUE DUE TO A HYDRAULIC FLUID LEAK DURING SET UP. A FRESENIUS FIELD SERVICE TECHNICIAN (FST) WAS CALLED ONSITE AND NOTED BLACKENING AND DISCOLORATION OF THE HEATER ROD INDICATING THERMAL DECOMPOSITION. FOLLOW UP WITH THE BMT REVEALED THAT A PATIENT WAS NOT CONNECTED TO THE MACHINE AT THE TIME OF THE INCIDENT AND THERE WAS NO HARM TO ANY PATIENTS OR INDIVIDUALS BECAUSE OF THIS MALFUNCTION. THE HEATER ROD WAS THE ORIGINAL FRESENIUS PART 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 ON ANY OTHER COMPONENTS. THE MACHINE HAS 667 HOURS AND IS PLUGGED INTO A HOSPITAL GRADE GROUND-FAULT CIRCUIT INTERRUPTER (GFCI) OUTLET. THE FST REPLACED THE HEATER ROD AND CALIBRATED THE HEAT TEMPERATURE CONTROL TO RESOLVE THE LOW TEMPERATURE ISSUE. THE FST COULD NOT DUPLICATE THE FLUID LEAK. MACHINE FUNCTIONAL TESTS WERE COMPLETED AND PASSED ONSITE AFTER REPAIR. THE COMPLAINT SAMPLE IS NOT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23167514 ↗
• MalfunctionSep 22, 2025Thermal Decomposition of Device; Thermal Decomposition of Device

  A USER FACILITY'S BIOMEDICAL TECHNICIAN (BMT) REPORTED TO TECHNICAL SUPPORT THAT A 2008T HEMODIALYSIS (HD) MACHINE DISPLAYED A "BICARB PUMP NO EOS" MESSAGE DURING POWER UP. A FRESENIUS FIELD SERVICE TECHNICIAN (FST) WAS CALLED ONSITE AND ORDERED A BICARBONATE PUMP FOR THE CUSTOMER. THE CUSTOMER RECEIVED THE NEW BICARBONATE PUMP AND DURING INSTALLATION SAW THAT THE ORIGINAL BICARBONATE PUMP HAD BROWN AND BLACK BURN MARKS ON THE HYDRAULIC FRAME AND THE DISTRIBUTION COVER. 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 BICARBONATE PUMP WAS THE ORIGINAL FRESENIUS PART 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 ON ANY OTHER COMPONENTS. THE MACHINE HAS APPROXIMATELY 1,583 HOURS AND IS PLUGGED INTO A HOSPITAL GRADE GROUND-FAULT CIRCUIT INTERRUPTER (GFCI) OUTLET. THE BMT REPLACED THE BICARBONATE PUMP, WHICH RESOLVED THE ISSUE. THE BMT REPORTED THAT THE MACHINE HAS BEEN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23111196 ↗
• MalfunctionSep 2, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED TO FRESENIUS THAT THE BLOOD PUMP ROTOR ON THE 2008T MACHINE DAMAGED THE BLOOD PUMP HOUSING DURING A PATIENT'S HEMODIALYSIS (HD) TREATMENT AND RESULTED IN BLOOD LOSS. A CAP CAME OFF AND EXPOSED THE GUIDE PIN WHICH PERFORATED THE BLOODLINE. A NURSE STATED DURING FOLLOW-UP THAT THE CLINIC STAFF VISUALLY OBSERVED THE REPORTED ISSUE. DROPLETS WERE IDENTIFIED THAT THE CLINIC STAFF DETERMINED WERE COMING FROM A HOLE IN THE BLOODLINES CAUSED FROM THE 2008T MACHINE BLOOD PUMP. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS NOT QUANTIFIED. NO SERIOUS INJURY OR REQUIRED MEDICAL INTERVENTION RESULTED FROM THE REPORTED ISSUE. THE PATIENT COMPLETED TREATMENT ON THE REPORTED EVENT DATE WITH THE SAME MACHINE AFTER THE BLOOD PUMP ROTOR WAS IMMEDIATELY REPLACED. FRESENIUS SUPPLIES WERE NOT USED FOR THIS TREATMENT. THE MACHINE REMAINS IN THE BACK ROOM AS A POTENTIAL BACKUP TO BE RETURNED TO SERVICE AT ANY TIME. THE SAMPLE WILL BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22938169 ↗

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-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-1868-2024 · Apr 17, 2024 · Open, Classified
  2008T BlueStar Hemodialysis Machine, Model 191126 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A.
• Z-0034-2024 · Sep 6, 2023 · Open, Classified
  2008T HD SYS. W/O CDX BLUESTAR
• Z-0033-2024 · Sep 6, 2023 · Open, Classified
  2008T HD SYS. CDX W/BIBAG BLUESTAR
• Z-0031-2024 · Sep 6, 2023 · Open, Classified
  2008T GEN 2 Bibag without CDX
• Z-0028-2024 · Sep 6, 2023 · Open, Classified
  2008T Hemodialysis SYS, with CDX
• 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-0734-2023 · Jul 27, 2022 · Open, Classified
  2008T and 2008TBluestar Hemodialysis Machines with CDX-Indicated for acute and chronic dialysis therapy in a healthcare facility Models: (1) 190713 2008T HEMODIALYSIS SYS., with
• 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

…and 2 more.