2008® Series Hemodialysis Machines 190610Recalls & reported problems

Summary

The FDA's MAUDE database contains 335 adverse event reports that list this exact device (DI 00840861100859), received between Jul 27, 2015 and Aug 17, 2026 — classified as 15 deaths, 27 injuries, 293 malfunctions.

The most frequently reported specific device problem is “Thermal Decomposition of Device” (113 reports).

1 FDA recall record name this device's identifier.

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. Dec 14, 2017Class IITerminated

   When the recirculation ultrafiltration (UF) Goal is set to a value greater than 200ml in service mode and the user starts a treatment using the SLED (Sustained Low Efficiency Dialysis) program the display will show an invalid message and the UF pump will run at the recirculation UF rate which may be up to 4000ml/hour. The SLED program is required to limit the UF rate to a maximum of 1000 ml/hour.

   Z-1278-2018 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 335 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 17, 2026Thermal Decomposition of Device; Melted

  A user facility biomedical technician (biomed) contacted Fresenius Medical Care (FME) technical support (TS) to report that a 2008K2 Hemodialysis machine would not power on. The biomed stated the machine stops during power-up (at 15% of initialization) and just audibly alarms. It does not continue powering up. During troubleshooting the biomed noticed a defective wire (scorched) on the power switch in the power supply. They replaced the power supply assembly with another module (unknown to be good or not). The biomed also replaced the motherboard. The biomed unplugged the actuator/sensor cables from the distribution board and the problem continues to occur. TS recommended the biomed replace the functional board or power logic board. The biomed was also advised to swap the power supply with a known good module. Upon follow-up with the biomed, it was reported that the power issue was resolved by replacing the functional board. The biomed said the replacement functional board was ordered through a third-party vendor, and the defective functional board was sent back to the vendor as part of an exchange. The biomed confirmed thermal damage was found during troubleshooting. One of the po

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50287017 ↗
• MalfunctionDec 30, 2025Thermal Decomposition of Device; Smoking; Thermal Decomposition of Device; Smoking

  An area technical operations manager (ATOM) reported to Fresenius technical support that smoke was noticed coming from the hydraulics of a 2008K2 machine during an acid clean cycle. When the machine was powered down and inspected, valve 25 was found to be swollen and charred. Additional details were provided upon follow-up with the ATOM. The ATOM confirmed that staff noticed smoke coming from the back of the machine when it was being cleaned at the end of the day. The smoke detector did not go off as the problem was identified rather quickly. There were no issues with the machine prior to this; the ATOM said it was used all day without any problems. Once the staff saw the smoke, they turned off the machine and unplugged it. There was also a burning smell present. There were no sparks or flames. A few hours later, the machine was inspected by the facility¿s biomedical technician (biomed). During the machine inspection, the biomed found that valve 25 inside the hydraulics was swollen and charred. The cable from pressure transducer #9 was also burnt as it was running alongside the valve. To resolve the issue, the biomed replaced pressure transducer #9, the cable, and valve 25. There w

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23928037 ↗
• MalfunctionNov 17, 2025Mechanical Problem; Reflux within Device; Mechanical Problem; Reflux within Device

  A USER FACILITY'S BIOMEDICAL TECHNICIAN (BMT) REPORTED THAT A 2008K2 HEMODIALYSIS (HD) MACHINE EXPERIENCED A SALINE BACK THAT BACKFILLED DURING A SIMULATED TREATMENT. THE BACKFILL WAS VISUALLY OBSERVED AT THE END OF TREATMENT. THE BMT SAID THAT HE SET THE MACHINE UP FOR SIMULATED TREATMENT IN HIS SHOP THEN WALKED AWAY. HE DID NOT KNOW IF THERE WERE ANY MACHINE ALARMS. HE DID NOT VISUALLY SEE THE BAG REFILLING. THE BMT REPORTED THAT THERE WERE NO QUICK DISCONNECTS ON THE DRAIN LINE AND THAT THE DRAIN LINE LENGTH AND HEIGHT WERE WITHIN SPECIFICATION. HE WAS NOT SURE IF THE MACHINE HAS HAD THE CBE UPGRADES. A PATIENT WAS NOT CONNECTED TO THE MACHINE AT THE TIME OF THE INCIDENT. THE BMT SAID THAT THE SALINE BAG BACKFILL WAS NOT DUE TO USER ERROR. THE MACHINE REMAINS OUT OF SERVICE AS HE HAS NOT YET HAD TIME TO WORK ON IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23570211 ↗
• MalfunctionOct 20, 2025Thermal Decomposition of Device; Thermal Decomposition of Device

  A FRESENIUS FIELD SERVICE TECHNICIAN (FST) REPORTED THAT DURING ANNUAL PREVENTATIVE MAINTENANCE A 2008K2 HEMODIALYSIS (HD) MACHINE'S NTC2 AND NTC3 WIRE SHEATH WAS MELTED. THE FST REPLACED THE NTC2 AND NTC3 TO RESOLVE THE ISSUE. 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 11,852 HOURS AND THE NTC2 AND NTC3 WERE THE ORIGINAL FRESENIUS PARTS ON THE MACHINE. DURING FOLLOW UP, THE BIOMEDICAL TECHNICIAN (BMT) REPORTED THAT THERE WAS NO CHARRING, BLACKENING, 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. MACHINE FUNCTIONAL TESTS WERE COMPLETED AND PASSED ONSITE AFTER REPAIR. THE COMPLAINT DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23337216 ↗
• InjuryJun 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A USER FACILITY BIOMEDICAL TECHNICIAN REPORTED THAT A HEMODIALYSIS (HD) PATIENT EXPERIENCED A ¿CODE BLUE¿ (SPECIFICS NOT PROVIDED) AFTER COMPLETING HD THERAPY ON A 2008K2 HD MACHINE. THE PATIENT REPORTEDLY COMPLETED TREATMENT, AND UPON STANDING/AMBULATING THE PATIENT BECAME DIZZY. THE PATIENT WAS ¿SAT DOWN¿ AND SHORTLY THEREAFTER THE CODE BLUE OCCURRED. THE BIOMEDICAL TECHNICIAN STATED THERE WERE NO DEVICE ISSUES OR ANYTHING UNUSUAL NOTED DURING TREATMENT. THE 2008K2 HD MACHINE WAS SEQUESTERED FOLLOWING THE SERIOUS ADVERSE EVENT(S), AND A FRESENIUS FIELD SERVICE TECHNICIAN (FST) WAS DISPATCHED TO PERFORM POST-EVENT FUNCTIONAL COMPLIANCE TESTING (PER COMPANY PROTOCOL). THE DEVICE PASSED ALL FUNCTIONAL COMPLIANCE AND ULTRAFILTRATION TESTING (E.G., SELF-TESTS, CONDUCTIVITY, TEMPERATURE, PH, ULTRAFILTRATION PUMP, FLUID REMOVAL), HOWEVER IT IS CURRENTLY UNKNOWN IF THE MACHINE WAS RETURNED TO SERVICE. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION, AND THUS FAR NO FURTHER DETAILS HAVE BEEN PROVIDED.

  Patient problems: Dizziness; Insufficient Information

  MAUDE report 22181415 ↗
• DeathMay 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A HOME HEMODIALYSIS (HD) PATIENT WAS IN TREATMENT WHEN THEY REPORTED NOT FEELING WELL (UNSPECIFIED). THE PATIENT WANTED TO END THE TREATMENT. IT WAS REPORTED THAT THE NURSE WANTED THE PATIENT TO CONTINUE WITH THE TREATMENT. THE PATIENT THEN WENT INTO CARDIAC ARREST. THE PATIENT WAS DISCONNECTED FROM THE MACHINE AND PASSED AWAY. IT IS BELIEVED THAT EMERGENCY MEDICAL SERVICES (EMS) ARRIVED AT THE PATIENT¿S HOME AND ATTEMPTED TO REVIVE THE PATIENT. ACCORDING TO THE PATIENT¿S SPOUSE, THE PATIENT HAD CARDIAC AND OTHER HEALTH ISSUES. NO ALARMS OR ISSUES WERE REPORTED DURING THE DIALYSIS TREATMENT. THE DATE OF THE EVENT WAS NOT PROVIDED. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION, AND THUS FAR NO FURTHER DETAILS HAVE BEEN PROVIDED.

  Patient problems: Cardiac Arrest

  MAUDE report 22107900 ↗
• InjuryApr 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 25/MAR/2025, FRESENIUS BECAME AWARE THIS FEMALE PATIENT WITH RENAL FAILURE (RF) ON HEMODIALYSIS (HD) UTILIZING A 2008K2 HEMODIALYSIS SYSTEM FOR RENAL REPLACEMENT THERAPY (RRT) ENCOUNTERED A MEDICAL EVENT DURING HD THERAPY ON (B)(6) 2025, WHICH REQUIRED A ¿RAPID RESPONSE¿ CALL FOR ADDITIONAL MEDICAL STAFF. DURING FOLLOW-UP, THE INPATIENT CHARGE NURSE (ICN) ON (B)(6) 2025, REPORTED THE RAPID RESPONSE CALL WAS NOT DUE TO A CARDIOPULMONARY ARREST, BUT RATHER A LOSS OF CONSCIOUSNESS DUE TO AN EPISODE OF INTRADIALYTIC HYPOTENSION (SPECIFICS NOT PROVIDED). THE PATIENT WAS PLACED ON AN INTRAVENOUS (IV) VASOPRESSOR (DRUG, DOSE, DURATION, FREQUENCY NOT PROVIDED) FOR BLOOD PRESSURE SUPPORT, AND DIALYSIS WAS DISCONTINUED FOR THE REMAINDER OF THE DAY. THE PATIENT STABILIZED AFTER THE SERIOUS ADVERSE EVENTS AND RESUMED HD THERAPY THE FOLLOWING DAY. AS OF (B)(6) 2025, THE PATIENT REMAINS HOSPITALIZED, HOWEVER HER CURRENT DISPOSITION WAS NOT PROVIDED. THE 2008K HEMODIALYSIS SYSTEM WAS SEQUESTERED FOLLOWING THE SERIOUS ADVERSE EVENTS. ON 28/MAR/2025, A FRESENIUS FIELD SERVICE TECHNICIAN (FST) WAS DISPATCHED TO PERFORM POST-EVENT FUNCTIONAL COMPLIANCE TESTING. THE DEVICE PASSED ALL FUNCTIONAL COM

  Patient problems: Insufficient Information

  MAUDE report 21752541 ↗
• MalfunctionFeb 19, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY'S BIOMEDICAL TECHNICIAN (BMT) REPORTED THAT A 2008T HEMODIALYSIS (HD) MACHINE HAD LOW (POSITIVE) TRANS-MEMBRANE PRESSURE (TMP) DURING A PATIENT'S HD TREATMENT. DURING FOLLOW UP, THE BMT REPORTED THAT THE MACHINE HAD LOW TMP AND NEGATIVE VENOUS PRESSURE. THE MACHINE WAS RETURNED TO SERVICE AFTER THE BMT REPLACED THE SENSOR BOARD. THE COMPLAINT DEVICE WAS REPORTED TO BE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. THE BMT SAID THAT THE PATIENT WAS MOVED TO ANOTHER MACHINE TO COMPLETE TREATMENT AND THEIR BLOOD WAS NOT RETURNED. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) IS UNKNOWN. IT IS UNKNOWN IF THERE WAS ANY PATIENT HARM OR ADVERSE EVENT. FOLLOW UP WITH A REGISTERED NURSE AND THE FACILITY ADMINISTRATOR RESULTED IN NO ADDITIONAL INFORMATION. NEITHER PARTY HAD ANY RECOLLECTION OR RECORD OF A BLOOD LOSS INCIDENT IN REGARD TO THE REPORTED ISSUE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21410534 ↗
• MalfunctionFeb 13, 2025Mechanical Problem; Reflux within Device; Mechanical Problem; Reflux within Device

  A BIOMEDICAL TECHNICIAN REPORTED TO FRESENIUS TECHNICAL SUPPORT (TS) THAT A 2008K2 HEMODIALYSIS (HD) MACHINE HAD A SALINE BAG FILLING ISSUE THAT OCCURRED DURING A PATIENT¿S TREATMENT. IT WAS UNKNOWN IF THE PATIENT WAS ABLE TO COMPLETE THEIR TREATMENT. HOWEVER, IT WAS CONFIRMED THE EVENT DID NOT RESULT IN ANY PATIENT INJURY OR HARM. IT WAS UNKNOWN IF THERE WERE ANY DIAGNOSTIC MESSAGES. UPON FOLLOW-UP IT WAS REVEALED THAT THE AIR SEPARATOR BOARD WAS UPGRADED, AND THE MACHINE WAS FULLY OPERATIONAL AGAIN. IT WAS CONFIRMED THAT THE DRAIN LINE LENGTH AND HEIGHT WERE WITHIN SPECIFICATION. IT WAS ALSO MENTIONED THAT THE BLOODLINES MAY NOT HAVE BEEN COMPATIBLE WITH THE MACHINE. 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 21381877 ↗
• MalfunctionDec 2, 2024Mechanical Problem; Reflux within Device; Mechanical Problem; Reflux within Device

  A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS TECHNICAL SUPPORT (TS) THAT A 2008K2 HEMODIALYSIS (HD) MACHINE DISPLAYED A ¿FILLING PROGRAM¿ MESSAGE DURING RECIRCULATION CAUSING THE SALINE BAG TO FILL. THERE WERE NO AUDIBLE ALARMS. THE MACHINE DOES NOT HAVE AN AIR SEPARATOR ADAPTER BOARD INSTALLED. THE TS REPRESENTATIVE ADVISED THE BIOMED TO INSTALL AN AIR SEPARATOR BOARD. ADDITIONAL INFORMATION WAS PROVIDED UPON FOLLOW-UP WITH THE BIOMED. THE BIOMED CONFIRMED THE MACHINE WAS GIVING A "FILLING PROGRAM" MESSAGE. THERE WERE NO OTHER ALARMS OR MESSAGES. THE BIOMED DID NOT WITNESS IT HAPPEN, BUT NURSES REPORTED TO THE BIOMED THAT THEY SAW FLUID BACKFLOWING INTO THE SALINE BAG DURING RECIRCULATION. THE SALINE BAG WAS REFILLING WITH DIALSYATE. THE BIOMED WAS UNSURE IF THE MACHINE HAD THE CBE UPGRADES COMPLETED. THEY CONFIRMED THE MACHINE WAS PASSING ALL PRESSURE AND ALARM TESTS. THE BIOMED COULD NOT SPEAK TO WHETHER OR NOT USER ERROR WAS A FACTOR. IT WAS CONFIRMED THAT THE DRAIN LINE LENGTH AND HEIGHT WERE BOTH WITHIN SPECIFICATION, AND THERE WERE NO QUICK DISCONNECTS USED ON THE DRAIN LINE. THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE EVENT. THE BACKFILL OCC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20825231 ↗
• InjuryOct 11, 2024Inadequate Ultra Filtration; Inadequate Ultra Filtration

  ON 7/OCT/2024, FRESENIUS BECAME AWARE (VIA A BIOMEDICAL TECHNICIAN) THIS 81-YEAR-OLD FEMALE PATIENT WITH END STAGE RENAL DISEASE (ESRD) ON HEMODIALYSIS (HD) FOR RENAL REPLACEMENT THERAPY (RRT) WAS UNDERGOING TREATMENT WHEN THE 2008K2 HEMODIALYSIS SYSTEM ENCOUNTERED AN ULTRAFILTRATION (UF) CHECK VALVE ERROR. THE PATIENT¿S TREATMENT WAS REPORTEDLY DISCONTINUED, AFTER WHICH SHE RESUMED HD THERAPY ON A DIFFERENT HD SYSTEM. DURING FOLLOW-UP, THE CLINICAL MANAGER (CM) REPORTED FIFTEEN MINUTES PRIOR TO THE COMPLETION OF TREATMENT (3.0 HOURS), WATER WAS NOTED TO BE LEAKING ON THE FLOOR. FOLLOWING THE DISCOVERY OF THE LEAK, THE PATIENT WAS FOUND TO BE UNCONSCIOUS AND THE UF ON THE 2008K2 HEMODIALYSIS SYSTEM WAS TURNED OFF. THE PATIENT WAS PLACED INTO THE TRENDELENBURG POSITION, OXYGEN WAS PROVIDED (VOLUME NOT PROVIDED), 300 ML OF NORMAL SALINE WAS ADMINISTERED, AND THE PATIENT REGAINED CONSCIOUSNESS. THE CM REPORTED TOO MUCH FLUID WAS REMOVED FROM THE PATIENT. THE PATIENT¿S PRETREATMENT WEIGHT WAS 53.6 KGS, AND HER POST TREATMENT WEIGHT WAS 50.9 KGS (SAME SCALE UTILIZED). IT WAS ALSO REPORTED THAT THE PATIENT ATE AND DRANK DURING TREATMENT. THE PATIENT¿S VITALS RETURNED TO BASELINE (VALUE N

  Patient problems: Loss of consciousness; Low Blood Pressure/ Hypotension; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20428551 ↗
• MalfunctionSep 16, 2024Thermal Decomposition of Device; Thermal Decomposition of Device

  A USER FACILITY BIOMEDICAL TECHNICIAN (BMT) REPORTED TO TECHNICAL SUPPORT THAT A 2008T MACHINE POWERED DOWN. THE BMT STATED ONE OF THE WIRES IN THE POWER SUPPLY WAS CHARRED. THERE WAS NO PATIENT INVOLVEMENT, PATIENT HARM, OR ADVERSE EVENT REPORTED. UPON FOLLOW-UP THE BMT STATED THE 2008T MACHINE HAD BEEN REMOVED FROM SERVICE DUE TO NOT POWERING UP CORRECTLY. UPON FURTHER EXAMINATION, IT WAS NOTED ONE OF THE WIRES LEADING FROM THE POWER CONTROL BOARD TO THE POWER SWITCH APPEARED CHARRED. THE BMT CONFIRMED NO SMOKE, BURNING SMELL OR FLAMES WERE NOTED AT ANY TIME DURING THE REPORTED EVENT. THE BMT STATED THAT THEY DID NOT OBSERVE ANY FLAME OR ARCING, OR ANY OTHER VISIBLE HEAT RELATED TO THE CHARRING FOUND ON THE SWITCH. THE BMT STATED THAT THE POWER SWITCH WAS THE ORIGINAL FRESENIUS PART ON THE MACHINE. THE BMT STATED THAT A REPLACEMENT UPPER POWER SUPPLY WAS ORDERED AND THE MACHINE REMAINS OUT OF SERVICE PENDING RECEIPT OF THE REPLACEMENT PARTS. ADDITIONALLY, THE BMT CONFIRMED THAT THERE WAS NO DAMAGE OBSERVED ON ANY OTHER COMPONENTS, OR ANY OTHER ADDITIONAL ISSUES ASSOCIATED WITH THE REPORTED EVENT. THE BMT CONFIRMED THAT A PATIENT WAS NOT CONNECTED TO THE MACHINE AT THE TIME OF THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20229729 ↗
• MalfunctionMar 27, 2024Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY BIOMEDICAL TECHNICIAN (BMT) REPORTED A 2008K2 UF CHECK VALVE 63 LEAKED DURING A PATIENT'S HEMODIALYSIS (HD) TREATMENT AND THE MACHINE WAS PULLED. THE BMT WAS UNSURE OF THE PATIENT FINISHED TREATMENT. PER BMT THERE WAS NO PATIENT INJURY. THE BMT STATED ONE OF THE PLASTIC TABS HOLDING THE TWO HALVES OF THE CHECK VALVE FAILED AND THE CHECK VALVE BROKE APART. THE CHECK VALVE WAS REPLACED TO RESOLVE THE ISSUE. UPON FOLLOW-UP, THE BMT STATED THE UF CHECK VALVE WAS NOTICED TO HAVE BEEN SPLIT APART DURING THE PATIENT'S TREATMENT, CAUSING A BLOOD LEAK. THE MACHINE REPORTEDLY ALARMED APPROPRIATELY DURING TREATMENT AS A RESULT OF THE LEAK. THE ESTIMATED BLOOD LOSS (EBL) WAS UNKNOWN. IT WAS UNKNOWN IF ANY DAMAGE WAS NOTED TO THE UF CHECK VALVE PRIOR TO TREATMENT OR WHAT MAY HAVE ATTRIBUTED TO THE CHECK VALVE BREAKING APART, BUT STATED THE MACHINE HAD PASSED PRE-CHECKS PRIOR TO THE PATIENT'S TREATMENT. THE BMT STATED IT WAS UNKNOWN IF THE PATIENT WAS ABLE TO COMPLETE THEIR TREATMENT FOLLOWING THE REPORTED EVENT, AND CONFIRMED THERE WAS NO KNOWN PATIENT INJURY AS A RESULT OF THE REPORTED ISSUE, WITH NO HARM OR ADVERSE EVENTS REPORTED. THE BMT STATED THE MACHINE WAS REPLACED WITH

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18989175 ↗
• InjuryOct 13, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  A THIRD-PARTY BIOMEDICAL TECHNICIAN (BIOMED) FOR A HOSPITAL REPORTED TO FRESENIUS THAT CASTER WHEELS ON A 2008K2 MACHINE CAME OFF OR DISLODGED WHICH MADE THE MACHINE TIP OVER. THE REPORTED ISSUE OCCURRED DURING PRETREATMENT SETUP. THERE WAS NO REPORTED PATIENT INVOLVEMENT. AN EMPLOYEE ATTEMPTED TO STOP THE FALL OF THE MACHINE WHICH RESULTED IN A SHOULDER INJURY. THE EMPLOYEE WAS OUT FROM WORK AND UPON INITIAL REPORTING WAS CURRENTLY ON LIGHT DUTY. THE CHARGE NURSE REPORTED THAT THEY WILL CHANGE THE CASTER WHEELS ON THE MACHINE TO THE ORIGINAL/SMALLER WHEELS. ADDITIONAL INFORMATION WAS PROVIDED DURING FOLLOW-UP. THE MACHINE FELL OUT OF AN ELEVATOR DURING TRANSPORT. A NURSE WHO WAS PRESENT FOR THE FALL ATTEMPTED TO CATCH THE MACHINE AS IT TIPPED OVER AND EXPERIENCED A SHOULDER INJURY. THE EXTENT OF THE SHOULDER INJURY WAS NOT PROVIDED. THE NURSE COULD NOT WORK FOR A COUPLE OF MONTHS AND RECEIVED REHABILITATION TREATMENT AS A RESULT OF THE INJURY. THE NURSE HAS RETURNED TO WORK. THE THIRD-PARTY BIOMED STATED THAT WHEN TRANSFERRING THE MACHINE FOR REPAIR THE MACHINE FELL AGAIN. THE BIOMED DID NOT ATTEMPT TO CATCH THE MACHINE AND IT HIT THE GROUND PUSHING THE ACUTE HANDLE THROUGH THE CA

  Patient problems: Unspecified Musculoskeletal problem

  MAUDE report 17930241 ↗
• MalfunctionAug 10, 2023Fluid/Blood Leak; Fluid/Blood Leak

  A CORPORATE MANAGER OF INVENTORY REPORTED TO FRESENIUS THAT A DIALYZER BLOOD LEAK OCCURRED AT A HEMODIALYSIS (HD) USER FACILITY. ADDITIONAL INFORMATION WAS OBTAINED THROUGH FOLLOW-UP WITH THE FACILITY¿S CHARGE NURSE (CN). THE BLOOD LEAK WAS INTERNAL, AND IT OCCURRED APPROXIMATELY TWO AND A HALF HOURS INTO HD TREATMENT. IT WAS REPORTED THAT A STREAK OF BLOOD WAS VISUALLY OBSERVED WITHIN THE DIALYZER, ON THE OUTSIDE OF THE FIBERS. THE MACHINE, A FRESENIUS 2008K2 MACHINE, DID NOT ALARM WITH A BLOOD LEAK ALERT. A BLOOD LEAK TEST STRIP WAS USED TO TEST THE DIALYSATE FOR BLOOD, AND IT TESTED POSITIVE. NO PHYSICAL DAMAGE WAS NOTED ON THE DIALYZER. FRESENIUS BLOODLINES WERE ALSO BEING UTILIZED DURING THE TREATMENT. AFTER THE BLOOD STREAK WAS IDENTIFIED, THE TREATMENT WAS PAUSED. THE PATIENT¿S BLOOD WAS NOT RETURNED. ESTIMATED BLOOD LOSS (EBL) WAS 300 ML. THE CN CONFIRMED THERE WAS NO PATIENT INJURY, NO ADVERSE EFFECTS WERE EXPERIENCED, AND NO MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THE REPORTED EVENT. THE PATIENT COMPLETED THEIR TREATMENT AFTER BEING RE-SETUP WITH NEW SUPPLIES ON THE SAME MACHINE. FOLLOWING THE EVENT, THE MACHINE WAS REMOVED FROM SERVICE FOR EVALUATION. THE FACILI

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17502877 ↗
• MalfunctionJul 13, 2023Thermal Decomposition of Device; Thermal Decomposition of Device

  A BIOMEDICAL TECHNICIAN (BIOMED) AT A USER FACILITY REPORTED THAT A FRESENIUS 2008K2 HEMODIALYSIS (HD) MACHINE HAD A BURNT POWER CONTROL BOARD. THIS WAS IDENTIFIED DURING TROUBLESHOOTING AN INTERMITTENT 24V LOW ALARM. 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 20,742 HOURS AND THE POWER CONTROL 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 BOARD. THE BIOMED REPLACED THE POWER CONTROL BOARD WHICH RESOLVED THE ISSUE. THE UNIT WAS RETURNED TO SERVICE AT THE USER FACILITY WITHOUT ISSUE AND WITHOUT REOCCURRENCE OF THE EVENT. THE POWER BOARD IS AVAILABLE FOR RETURN TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17315947 ↗
• MalfunctionJun 13, 2023Thermal Decomposition of Device; Thermal Decomposition of Device

  A FRESENIUS FIELD SERVICE TECHNICIAN (FST) REPORTED THAT A FRESENIUS 2008K2 HEMODIALYSIS (HD) MACHINE HAD A BURNED POWER PLUG. THE BURNED POWER PLUG WAS NOTICED DURING MACHINE REPAIR. THE FST WAS INITIALLY CALLED ONSITE BY THE USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) WHEN THE MACHINE INTERMITTENTLY ALARMED IN ALL MODES WITH A 12V HIGH 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 MACHINE HAS APPROXIMATELY 22,290 HOURS AND THE PLUG IS THE ORIGINAL FRESENIUS PART ON THE MACHINE. THE BIOMED REPORTED THAT THERE WAS NO MELTING, BURNING SMELL, SMOKE, SPARK, FLAME, OR ARCING OBSERVED. THE MACHINE IS PLUGGED INTO A HOSPITAL GRADE GROUND-FAULT CIRCUIT INTERRUPTER (GFCI) OUTLET. THE FST REPLACED THE PLUG TO ADDRESS THE POWER PLUG DISCOLORATION. THE FST WAS UNABLE TO DUPLICATE THE INITIAL 12V ERROR. HOWEVER A LEAK WAS IDENTIFIED AT BICARBONATE (BICARB) MIXING CHAMBER #2 ABOVE THE FLOW MOTOR. FLUID MAY HAVE BEEN INSIDE THE FLOW MOTOR AS IT WAS FOUND TO BE RUSTED. THE FST DETERMINED THE WET FLOW MOTOR CAUSED THE INTERMITTENT VOLTAGE ALARMS. THE BICARB MIXING CHAMBER #2, FLOW

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17119128 ↗
• MalfunctionMay 22, 2023Inadequate Ultra Filtration; Inadequate Ultra Filtration

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16974397 ↗
• MalfunctionMay 3, 2023Thermal Decomposition of Device; Thermal Decomposition of Device

  A USER FACILITY BIOMEDICAL TECHNICIAN (BMT) REPORTED A HEMODIALYSIS (HD) MACHINE HAD NO POWER. NOTHING HAPPENED WHEN THE BMT PRESSED THE POWER BUTTON. THE BMT FOUND SIGNS OF A LEAK (WHITE BUILDUP) ON THE BIC PUMP AND SCORCH MARKS ON THE ACID PUMP CABLE. THE BMT AGREED TO RETURN THE ACID PUMP WITH A BLUE OUTPUT NIPPLE FOR FAILURE ANALYSIS. THE BMT WAS ADVISED TO SWAP THE POWER SUPPLY, POWER LOGIC BOARD OR FRONT PANE. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT RECEIVED TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16858427 ↗
• InjuryApr 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 13/APR/2023, FRESENIUS BECAME AWARE (VIA A BIOMEDICAL TECHNICIAN) THIS UNKNOWN PATIENT WITH RENAL FAILURE (RF) ON HEMODIALYSIS (HD) FOR RENAL REPLACEMENT THERAPY (RRT) EXPERIENCED A ¿CODE BLUE¿ (CARDIAC ARREST) DURING HD THERAPY ON (B)(6) 2023. NO ADDITIONAL INFORMATION WAS PROVIDED DURING INTAKE. A REVIEW OF THE FUNCTIONAL COMPLIANCE TESTING AND UF CHECKLIST PERFORMED ON (B)(6) 2023 REVEALED THE 2008K2 HEMODIALYSIS SYSTEM PERFORMED WITHIN MANUFACTURER SPECIFICATIONS AND WAS RETURNED TO SERVICE. SUBSEQUENT ATTEMPTS TO OBTAIN ADDITIONAL CLINICAL INFORMATION (E.G., HD TREATMENT DATA, TIMELINE OF EVENTS, CAUSALITY, PATIENT DEMOGRAPHICS, DISCHARGE SUMMARY, MACHINE RECORDS, HOSPITAL RECORDS) WERE UNSUCCESSFUL.

  Patient problems: Cardiac Arrest

  MAUDE report 16770983 ↗
• MalfunctionFeb 20, 2023Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY CERTIFIED CLINICAL HEMODIALYSIS TECHNICIAN (CCHT) REPORTED AFTER TREATMENT BEGAN, THE TECHNICIAN NOTICED THAT THE TUBING WAS PINCHED IN THE BLOOD PUMP ROTOR AREA, CAUSING A BLOOD SPILL AND CREATING A LEVEL DETECTOR (AIR IN BLOOD) ALARM. TREATMENT WAS TERMINATED AND THE MACHINE WAS PLACED OUT OF SERVICE. THE PATIENT WAS MOVED TO ANOTHER MACHINE, BEGINNING A NEW SETUP AND TREATMENT RESUMED UNTIL COMPLETED. IT WAS REPORTED A BLOOD LINE WAS PUNCTURED. THE PATIENT WAS MOVED TO ANOTHER MACHINE TO BEGIN AND COMPLETE DIALYSIS TREATMENT. THERE WAS NO PATIENT INJURY, NO ADVERSE EFFECTS WERE EXPERIENCED, AND NO MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THE REPORTED EVENT. UPON FOLLOW-UP, THE CCHT STATED THE BLOOD PUMP ROTOR OF THE MACHINE, A FRESENIUS 2008K2 MACHINE, WAS COMING OFF AND CAUSED A BLOOD LEAK TO OCCUR. THE CCHT STATED THE ROTOR GUIDE SLEEVES (AROUND THE PINS) WERE COMING OFF AND CUT THE BLOOD PUMP TUBING. THE MACHINE WAS PULLED FROM SERVICE PENDING REPLACEMENT OF THE BLOOD PUMP ROTOR. THE ROTOR WAS THE ORIGINAL TO THE MACHINE. THE CCHT STATED THAT FRESENIUS BLOODLINES WERE USED FOR TREATMENT AND CONFIRMED THAT THERE WERE NO DEFECTS OR DAMAGE SEEN ON THE MAC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16403828 ↗
• MalfunctionNov 14, 2022Mechanical Problem; Reflux within Device; Mechanical Problem; Reflux within Device

  A BIOMEDICAL TECHNICIAN (BIOMED) AT A USER FACILITY REPORTED THAT A FRESENIUS 2008K2 HEMODIALYSIS (HD) MACHINE HAD A SALINE BAG BACKFILL DURING SET-UP FOR USE. A PATIENT WAS NOT CONNECTED TO THE MACHINE AT THE TIME OF THE INCIDENT. ADDITIONAL INFORMATION WAS REQUESTED HOWEVER A RESPONSE WAS NOT RECEIVED. NO PARTS WERE RETURNED TO THE MANUFACTURER FOR A PHYSICAL EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15788076 ↗
• DeathOct 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO FRESENIUS THAT THE PATIENT EXPERIENCED AN ARREST (STATED AS ¿CODED¿ IN THE INITIAL REPORTING) DURING ACUTE HEMODIALYSIS (HD) THERAPY UTILIZING THE 2008K2 DIALYSIS SYSTEM. THERE WAS NO SPECIFIC ALLEGATION THIS EVENT WAS DUE TO A DEFICIENCY OR MALFUNCTION OF ANY FRESENIUS PRODUCT(S) OR DEVICE(S) IN THE INITIAL REPORTING. UPON FOLLOW UP WITH A HOSPITAL HD REGISTERED NURSE, IT WAS REPORTED THIS PATIENT WAS INITIALLY HOSPITALIZED (EXACT DATE UNKNOWN) FOR RESPIRATORY FAILURE REQUIRING MECHANICAL VENTILATION. THE PATIENT WAS NOT A CHRONIC DIALYSIS PATIENT. THE PATIENT WAS PLACED ON ACUTE HD THERAPY FOR THERAPEUTIC EFFECT DURING THIS ADMISSION FOLLOWING RENAL FAILURE DUE TO UNSPECIFIED COMORBIDITIES, ON A HOSPITAL-PROVIDED 2008K2 HD DEVICE. THE PATIENT BEGAN HD TREATMENT ON (B)(6) 2022 AND APPROXIMATELY ONE HOUR INTO TREATMENT, THE PATIENT EXPERIENCED A CARDIAC ARREST. THE HOSPITAL CARDIAC ARREST TEAM ARRIVED BEDSIDE AND AFTER MULTIPLE ROUNDS OF CARDIOPULMONARY RESUSCITATION, THE PATIENT HAD A RETURN OF SYSTEMIC CIRCULATION. THE PATIENT REMAINED IN CRITICAL CONDITION FOLLOWING THE ARREST AND THE DECISION WAS MADE BY FAMILY TO DISCONTINUE ALL MODALITIES OF THERAPEUTIC AND

  Patient problems: Cardiac Arrest; Respiratory Failure

  MAUDE report 15671294 ↗
• InjuryOct 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE FRESENIUS 2008K2 HEMODIALYSIS MACHINE HAD A SAFETY CHECK PERFORMED DUE TO AN UNSPECIFIED PATIENT INCIDENT. ADDITIONAL FOLLOW-UP WAS CONDUCTED WITH A BIOMEDICAL ENGINEER. HOWEVER, VERY LIMITED DETAILS ABOUT THE PATIENT EVENT WERE AVAILABLE. IT WAS STATED AN UNKNOWN PATIENT CODED WHILE ON THE FRESENIUS 2008K2 HEMODIALYSIS MACHINE. IT WAS REPORTED AS PART OF CLINIC POLICY, THE MACHINE IS PUT THROUGH A SAFETY CHECK AFTER ANY INCIDENT. THE BIOMEDICAL ENGINEER REPORTED THE MACHINE WAS NOT SUSPECTED TO HAVE CAUSED ANY HARM TO THE PATIENT. IT WAS STATED THE PATIENT INCIDENT WAS DUE TO PATIENT COMORBIDITIES AND NOT RELATED TO FRESENIUS PRODUCT. PER THE BIOMEDICAL ENGINEER, THE FRESENIUS 2008K2 HEMODIALYSIS MACHINE PASSED ALL TESTS AND HAS RETURNED TO USE WITHOUT ANY ISSUES. NO FURTHER INFORMATION WAS AVAILABLE.

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

  MAUDE report 15602326 ↗
• MalfunctionJul 13, 2022Mechanical Problem; Reflux within Device; Mechanical Problem; Reflux within Device

  A BIOMEDICAL TECHNICIAN (BIOMED) AT A USER FACILITY REPORTED THAT A FRESENIUS 2008K2 HEMODIALYSIS (HD) MACHINE HAD A SALINE BAG BACKFILL DURING THE RECIRCULATION PHASE OF SETUP. THE BACKFILL WAS VISUALLY OBSERVED BY THE NURSING STAFF. THE BAG THAT WAS PRIMED TO FILL WITH 500 ML FILLED TO APPROXIMATELY 1000 ML.. A PATIENT WAS NOT CONNECTED TO THE MACHINE AT THE TIME OF THE INCIDENT. THE BIOMED REPORTED THAT THERE WERE NO QUICK DISCONNECTS ON THE DRAIN LINE AND THAT THE DRAIN LINE LENGTH AND HEIGHT WERE WITHIN SPECIFICATION. THE BIOMED BELIEVES THE SALINE BAG BACKFILL WAS NOT DUE TO USER ERROR. IT WAS CONFIRMED THAT THE UNIT HAS RECEIVED THE CBE HARDWARE AND SOFTWARE UPGRADES. THE BIOMED STATED THAT THE MACHINE WILL NOT BE REPAIRED DUE TO AGE AND COST OF REPAIRS. THE MACHINE HAS BEEN REMOVED FROM SERVICE PERMANENTLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15008261 ↗