2008® Series Hemodialysis Machines 190395Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00840861100958), received between Nov 19, 2015 and Oct 24, 2023 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (2 reports).

3 FDA recall records name this device's identifier, 3 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Jun 3, 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-2344-2024 · Root cause: Component design/selection · Recall details · FDA record ↗

2. Jun 3, 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-2343-2024 · Root cause: Component design/selection · Recall details · FDA record ↗

3. Jun 3, 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-2347-2024 · Root cause: Component design/selection · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 24, 2023Obstruction of Flow; Obstruction of Flow

  A HOME HEMODIALYSIS (HD) PATIENT REPORTED THEY FORGOT TO UNCLAMP THE HEPARIN LINE DURING THEIR TREATMENT ON A FRESENIUS 2008K@HOME MACHINE, AND THE MACHINE FAILED TO ALARM. THE INCIDENT RESULTED IN BLOOD LOSS DUE TO BLOOD WITHIN THE SYSTEM COAGULATING AFTER FOUR HOURS OF TREATMENT. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 180 ML. UPON FOLLOW-UP WITH THE FIELD SERVICE TECHNICIAN (FST) FAMILIAR WITH THE EVENT, IT WAS INDICATED THAT USE ERROR WAS POSSIBLY INVOLVED. WHEN THE TECHNICIAN TESTED THE HEPARIN PUMP, IT WAS CONFIRMED THAT THE MACHINE ALARMED APPROPRIATELY. ALTHOUGH THE PATIENT FORGOT TO UNCLAMP THE HEPARIN LINE, THE TECHNICIAN STATED THAT THE MACHINE SHOULD HAVE PRODUCED A HEPARIN PUMP ALARM. IT WAS CONFIRMED THAT THE PATIENT WAS USING THE HEPARIN PUMP FOR THE TREATMENT. THE TECHNICIAN STATED THERE WAS NO BOLUS DELIVERY SET UP, BUT THE HEPARIN PUMP SETTINGS WERE REPORTEDLY SET PROPERLY. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION, AND THUS FAR NO FURTHER DETAILS HAVE BEEN PROVIDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18000010 ↗
• MalfunctionJul 21, 2022Mechanical Problem; Reflux within Device; Mechanical Problem; Reflux within Device

  A BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS TECHNICAL SERVICES THAT A 2008K@HOME HEMODIALYSIS (HD) MACHINE HAD A SALINE BAG BACKFILL WHILE RECIRCULATING DURING SET-UP FOR USE. THE MACHINE PROVIDED AN AUDIBLE ALARM ALONG WITH A ¿10 FILL PGM IN 1 HR¿ ERROR MESSAGE. A PATIENT WAS NOT CONNECTED TO THE MACHINE AT THE TIME OF THE INCIDENT. THE BIOMED REPORTED THAT THE MACHINE DOES NOT HAVE THE AIR SEPARATOR ADAPTER BOARD INSTALLED. THE FRESENIUS TECHNICAL SUPPORT REPRESENTATIVE ADVISED THE BIOMED TO INSTALL THE AIR SEPARATOR BOARD AND PROVIDED PART INFORMATION. ADDITIONAL INFORMATION WAS REQUESTED HOWEVER A RESPONSE WAS NOT RECEIVED. NO PARTS WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15076016 ↗
• MalfunctionFeb 6, 2018Thermal Decomposition of Device; Thermal Decomposition of Device

  A BIOMEDICAL TECHNICIAN (BIOMED) AT A USER FACILITY REPORTED THAT A FRESENIUS 2008K@HOME HEMODIALYSIS (HD) MACHINE HAD A BURNED POWER PLUG. THE BURNED POWER PLUG WAS NOTICED DURING REGULAR INSPECTION. A PATIENT WAS NOT CONNECTED TO THE MACHINE AT THE TIME OF THE INCIDENT AND THERE WAS NO HARM TO ANY PATIENTS OR INDIVIDUALS BECAUSE OF THIS MALFUNCTION. THE PLUG WAS THE ORIGINAL FRESENIUS PART ON THE MACHINE. THE BIOMED REPORTED THAT THERE WAS NO MELTING, BURNING SMELL, SMOKE, SPARK, OR FLAME OBSERVED. THE BIOMED REPORTED THAT THE MACHINE HAS NOT HAD ANY PAST PROBLEMS WITH FAILING THE ELECTRICAL LEAKAGE TEST AND THAT THERE WAS NO DAMAGE OBSERVED ON ANY OTHER COMPONENTS. THE MACHINE HAS APPROXIMATELY 4,500 HOURS AND IS PLUGGED INTO A HOSPITAL GRADE GROUND-FAULT CIRCUIT INTERRUPTER (GFCI) OUTLET. THE BIOMED REPLACED THE PLUG, WHICH RESOLVED THE ISSUE. THE BIOMED REPORTED THAT THE MACHINE IS READY FOR SERVICE. THE POWER PLUG WAS STATED TO BE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

  Patient problems: No Patient Involvement

  MAUDE report 7246271 ↗
• InjuryDec 26, 2017Pressure Problem; Pressure Problem

  THE PATIENT WAS HAVING HEMODIALYSIS (HD) TREATMENT AT HOME WHEN THE FRESENIUS 2008K AT HOME HD MACHINE WAS GIVING HIGH TRANSMEMBRANE PRESSURE (TMP) ALARMS. THE PATIENT WAS FOUND UNCONSCIOUS BY THE PERSONAL SUPPORT WORKER (PSW) AND THE PATIENT¿S WIFE A FEW MINUTES AFTER THE MACHINE WAS GIVING HIGH TMP ALARMS. THE PATIENT LOST A CIRCUIT OF BLOOD AS THE PSW WAS INSTRUCTED TO NOT RETURN THE PATIENT¿S BLOOD. THE ESTIMATED BLOOD LOSS WAS REPORTEDLY 300ML. THE PATIENT WAS SENT TO THE EMERGENCY ROOM (ER) HOSPITAL VIA AMBULANCE FOR EVALUATION. IN THE ER, THE PATIENT HAD A COMPUTERIZED TOMOGRAPHY (CT) OF THE HEAD, CHEST X-RAY, AND BLOOD WORK. THE PATIENT RECEIVED MEDICATIONS FOR HIGH BLOOD PRESSURE AND WAS LATER DIALYZED AT THE IN-CENTER FACILITY. THE PATIENT WAS DISCHARGED TO HOME THE SAME DAY WITH INSTRUCTIONS TO COMPLETE CARDIAC FOLLOW-UP. THE PATIENT IS CONTINUING WITH HD THERAPY WITHOUT ANY FURTHER PROBLEM. FOLLOWING THE EVENT, A FRESENIUS MEDICAL CARE CANADA TECHNICIAN PERFORMED MACHINE EVALUATION. THE TECHNICIAN REPORTED THAT THE TMP WAS FOUND OUT OF CALIBRATION AND WAS A POSSIBLE DIALYSATE PRESSURE TRANSDUCER CALIBRATION ISSUE. THE TECHNICIAN PERFORMED TMP CALIBRATION AND RETURNED TH

  Patient problems: Blood Loss; Loss of consciousness

  MAUDE report 7145471 ↗
• MalfunctionNov 19, 2015Fluid/Blood Leak; Mechanical Jam

  A PATIENT REPORTED THAT APPROXIMATELY FOUR HOURS INTO THE DIALYSIS TREATMENT, THE MACHINE EXPERIENCED AN AIR DETECT ALARM. THE PATIENT NOTED THAT THE COMBISET TUBING BECAME BUNCHED UP WITHIN THE ROTOR SEGMENT OF THE BLOOD PUMP. THE PATIENT WAS NOT ABLE TO DISLODGE THE TUBING FROM THE ROTOR SEGMENT WHICH RESULTED IN THE LOSS OF A FULL CIRCUIT OF BLOOD. THE ESTIMATED BLOOD LOSS (EBL) IS 500CC WHICH IS AN APPROXIMATION OF BLOOD THAT REMAINED IN THE DIALYZER AND LINES COULD NOT BE RETURNED TO THE PATIENT. THE PATIENT WAS SWITCHED TO ANOTHER MACHINE WITH A NEW SETUP TO CONTINUE AND COMPLETE TREATMENT WITHOUT ANY FURTHER ISSUES. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT AND NO MEDICAL INTERVENTION WAS REQUIRED. FOLLOW UP INFORMATION WAS PROVIDED BY THE AT-HOME NURSE WHO REVEALED THAT THE PATIENT HAS BEEN ON DIALYSIS FOR APPROXIMATELY 5 YEARS AND IS VERY METICULOUS WITH THE SETUP. ADDITIONALLY, THE NURSE CONFIRMED THAT THE PATIENT HAD FOLLOWED PROPER PROCEDURE WHEN THE BLOODLINE WAS INSERTED INTO THE BLOOD PUMP SEGMENT. THE ACTUAL SAMPLE IS NOT AVAILABLE FOR EVALUATION. FURTHER INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5249562 ↗
• MalfunctionNov 19, 2015Fluid/Blood Leak; Mechanical Jam

  A PATIENT REPORTED THAT APPROXIMATELY FOUR HOURS INTO THE DIALYSIS TREATMENT, THE MACHINE EXPERIENCED AN AIR DETECT ALARM. THE PATIENT NOTED THAT THE COMBISET TUBING BECAME BUNCHED UP WITHIN THE ROTOR SEGMENT OF THE BLOOD PUMP. THE PATIENT WAS NOT ABLE TO DISLODGE THE TUBING FROM THE ROTOR SEGMENT WHICH RESULTED IN THE LOSS OF A FULL CIRCUIT OF BLOOD. THE ESTIMATED BLOOD LOSS (EBL) IS 500CC WHICH IS AN APPROXIMATION OF BLOOD THAT REMAINED IN THE DIALYZER AND LINES COULD NOT BE RETURNED TO THE PATIENT. THE PATIENT WAS SWITCHED TO ANOTHER MACHINE WITH A NEW SETUP TO CONTINUE AND COMPLETE TREATMENT WITHOUT ANY FURTHER ISSUES. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT AND NO MEDICAL INTERVENTION WAS REQUIRED. FOLLOW UP INFORMATION WAS PROVIDED BY THE AT-HOME NURSE WHO REVEALED THAT THE PATIENT HAS BEEN ON DIALYSIS FOR APPROXIMATELY 5 YEARS AND IS VERY METICULOUS WITH THE SETUP. ADDITIONALLY, THE NURSE CONFIRMED THAT THE PATIENT HAD FOLLOWED PROPER PROCEDURE WHEN THE BLOODLINE WAS INSERTED INTO THE BLOOD PUMP SEGMENT. THE ACTUAL SAMPLE IS NOT AVAILABLE FOR EVALUATION. FURTHER INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5249559 ↗
• InjuryNov 19, 2015Adverse Event Without Identified Device or Use Problem

  A HEMODIALYSIS PT REPORTED BEING TREATED FOR AN INFECTION THAT PERSISTED FOR OVER 3 WEEKS. ANTIBIOTICS WAS ADMINISTERED AT THE HOSPITAL TO TREAT THE INFECTION. THE AT-HOME NURSE REVEALED THE PT HAS BEEN ON DIALYSIS FOR APPROXIMATELY 5 YEARS AND IS VERY METICULOUS ABOUT THE TREATMENT SETUP. THE PT COMPLETES SIX TREATMENTS EACH WEEK. FURTHER INFO HAS BEEN REQUESTED, HOWEVER, NO NEW DETAILS HAVE BEEN MADE AVAILABLE. SPECIFIC INFO PERTAINING TO THE TYPE OF INFECTION OR THE RELATIONSHIP BETWEEN THE INFECTION AND THE HEMODIALYSIS TREATMENT HAS NOT BEEN PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 5247328 ↗