2008® Series Hemodialysis Machines 190828Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00840861100941), received between Aug 7, 2017 and Apr 29, 2022 — classified as 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (1 report).

2 FDA recall records name this device's identifier, 2 still open.

19 other recalls cover devices cleared under the same FDA submission (K070049, K150708); 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 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-2341-2024 · 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-2345-2024 · Root cause: Component design/selection · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryApr 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO FRESENIUS THAT THIS HOME HEMODIALYSIS PATIENT WAS IN TREATMENT UTILIZING THE 2008K@HOME HEMODIALYSIS MACHINE WHEN THEY BEGAN FEELING UNWELL. THE PATIENT COMPLAINED OF DIZZINESS AND NUMBNESS IN THE LEFT LEG. THE EVENT OCCURRED AT APPROXIMATELY 1514 HOURS (15 MINUTES AFTER THE START OF TREATMENT) AFTER THE PATIENT RECEIVED A HIGH VENOUS PRESSURE ALARM. THE PATIENT¿S BLOOD WAS RETURNED. THE PARAMEDICS WERE CALLED, AND THE PATIENT WAS TRANSPORTED TO THE HOSPITAL. ADDITIONAL FOLLOW-UP YIELDED LIMITED INFORMATION RELATED TO THE EVENT. THE PATIENT WAS ADMITTED TO THE HOSPITAL. THE PATIENT WAS TRANSITIONED TO IN-CENTER HEMODIALYSIS AND DISCONTINUED USE OF THE HOME HEMODIALYSIS MACHINE. NO ADDITIONAL DETAILS WERE AVAILABLE RELATED TO THE PATIENT¿S HOSPITAL COURSE OR DATE OF DISCHARGE. AN EVALUATION OF THE MACHINE ON 13/APR/2022 FOUND THE VENOUS AND ARTERIAL TRANSDUCER PRESSURES TO MEASURE AS EXPECTED WITH NO LEAKAGE OBSERVED. ADDITIONALLY, THE PRESSURE AND ALARM TESTS PASSED, AND THE ELECTRICAL SAFETY CHECK WAS CARRIED OUT SUCCESSFULLY. FURTHERMORE, THE BLOOD PRESSURE MODULE AND CUFFS WERE FOUND TO BE WORKING AS EXPECTED.

  Patient problems: Dizziness; Numbness

  MAUDE report 14251875 ↗
• MalfunctionApr 8, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED TO FRESENIUS THAT THIS PATIENT WITH END STAGE RENAL DISEASE (ESRD) ON HOME HEMODIALYSIS (HD) FOR RENAL REPLACEMENT THERAPY (RRT) NEGLECTED TO OPEN THE HEPARIN LINE CLAMP PRIOR TO TREATMENT AND THE PATIENT¿S EXTRACORPOREAL CIRCUIT ¿COAGULATED.¿ THE PATIENT ALLEGED THE 2008K@HOME HEMODIALYSIS SYSTEM DID NOT ALARM THAT THE HEPARIN LINE WAS CLAMPED, AND THEREFORE THE PATIENT WAS REQUIRED TO TERMINATE TREATMENT EARLY. THE PATIENT'S ESTIMATED BLOOD LOSS (EBL) FOR THIS TREATMENT IS APPROXIMATELY 325 ML. THE PATIENT DID NOT EXPERIENCE A SERIOUS INJURY, ADVERSE EVENT, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THE REPORTED EVENT. AN INSPECTION OF THE MACHINE AFTER THE EVENT REVEALED THE HEPARIN PUMP REQUIRED REPLACEMENT DUE TO SIGNS OF ¿KINKING.¿ A NEW HEPARIN PUMP WAS INSTALLED AND DURING FOLLOW-UP RESTRAINT TESTING, THE 2008K@HOME HEMODIALYSIS SYSTEM ALARMED APPROPRIATELY. ADDITIONALLY, IT WAS REPORTED ALL POST EVENT FUNCTIONAL COMPLIANCE CHECKS WERE PASSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11638850 ↗
• MalfunctionApr 7, 2021Inadequate Ultra Filtration; Inadequate Ultra Filtration

  A HOME HEMODIALYSIS (HD) PATIENT REPORTED TO FRESENIUS MEDICAL CARE (B)(4) THAT THEIR 2008K@HOME HD MACHINE WAS REMOVING TOO MUCH FLUID DURING TREATMENT. THE ULTRAFILTRATION (UF) PROBLEM IDENTIFICATION CHECKLIST WAS COMPLETED BY AN FMC CANADA TECHNICIAN, AND NO PROBLEMS WERE FOUND. THE PATIENT STATED THEY WOULD CONTINUE TO USE THE MACHINE AND REPORT ANY FURTHER ISSUES. THROUGH MULTIPLE FOLLOW-UP ATTEMPTS WITH FMC CANADA, NO ADDITIONAL INFORMATION COULD BE OBTAINED. THE TECHNICAL REPRESENTATIVE FROM CANADA WAS UNABLE TO REACH THE PATIENT FOR MORE INFORMATION. HOWEVER, THE UF PROBLEM CHECKLIST PROVIDED AT INTAKE INDICATES THE 2008K@HOME MACHINE PASSED ALL TESTS. THE TECHNICIAN STATED THEY ¿BELIEVE THE PATIENT WAS DOING SOMETHING WRONG WHEN WEIGHING [THEMSELVES] AND HAS NOT HAD ANY ISSUES SINCE THEN¿. THERE WERE NO REPORTS OF ANY ADVERSE EVENTS. IN ADDITION, THERE WAS NO INDICATION THAT ANY PARTS HAD TO BE REPLACED OR CALIBRATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11631988 ↗
• InjuryFeb 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT ON HEMODIALYSIS (HD) UTILIZING THE 2008K@HOME HEMODIALYSIS SYSTEM WAS URGENTLY HOSPITALIZED FOR A POSSIBLE AIR EMBOLISM. THE PATIENT RETURNED HOME FOUR HOURS LATER. THE MACHINE WAS CHECKED THE FOLLOWING MORNING. THE BLOOD SERUM LEVEL IN THE VENOUS CHAMBER WAS 10MM ABOVE THE LEVEL DETECTOR DOOR; HOWEVER, THE PATIENT REPORTED THAT THE LEVEL IN THE VENOUS CHAMBER WAS FINE ALL THE WAY UNTIL DISCONNECT. THE LEVEL CALIBRATION CHECKED BOTH CHANNELS AND THE CALIBRATIONS WERE FINE. THE BLOOD PUMP WAS FOUND TO HAVE NO PROBLEMS. THE MACHINE PASSED ALL TESTS. NO PROBLEMS WERE FOUND WITH THE MACHINE. ADDITIONAL INFORMATION CONFIRMED THE PATIENT WAS 2 HOURS INTO A 3.5 HOUR HD TREATMENT WHEN AN EMERGENCY WAS ENCOUNTERED. NO SIGNS OR SYMPTOMS WERE REPORTED. THE PATIENT REPORTEDLY DISCONNECTED FROM THE MACHINE PER EMERGENCY DISCONNECT PROCEDURES. THE PATIENT WAS TRANSPORTED TO THE HOSPITAL VIA EMERGENCY MEDICAL SERVICES (EMS). IT IS UNKNOWN WHAT TESTING OR EVALUATION WAS COMPLETED AT THE HOSPITAL OR IF ANY MEDICAL INTERVENTION WAS RECEIVED. THE PATIENT WAS DISCHARGED FOUR HOURS AFTER ARRIVAL. THERE IS NO CONFIRMATION THAT THE PATIENT WAS DIAGNOSED WITH AN AIR EMBOLISM

  Patient problems: Air Embolism

  MAUDE report 9769296 ↗
• MalfunctionJul 11, 2019Mechanical Problem; Reflux within Device; Mechanical Problem; Reflux within Device

  A USER FACILITY BIOMED TECHNICIAN REPORTED TO TECHNICAL SUPPORT THAT A 2008K MACHINE EXPERIENCED A BAG OF SALINE FILLING UP. THE SALINE BAG BACKFILL OCCURRED DURING RECIRCULATION. THE PATIENT WAS NOT CONNECTED DURING RECIRCULATION. 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 MACHINE WAS RETURNED TO SERVICE WITHOUT A RECURRENCE OF THE REPORTED ISSUE. AN AIR SEPARATOR CONDUCTIVITY CABLE WAS CHANGED.

  Patient problems: No Patient Involvement

  MAUDE report 8779788 ↗
• MalfunctionMay 31, 2018Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WAS HAVING ABDOMINAL PAIN DURING THEIR HEMODIALYSIS (HD) THERAPY ON A FRESENIUS 2008K@HOME MACHINE AND THE MACHINE BEGAN BEEPING. THE PATIENT PUSHED BUTTONS (UNKNOWN WHICH ONES) AND THE MACHINE BEGAN TO ALARM. THE PATIENT TRIED TO MANUALLY PUMP THE BLOOD BACK BUT WAS TOO WEAK TO DO SO DUE TO HAVING THE FLU. THE PATIENT¿S ESTIMATED BLOOD LOSS WAS 100 ML. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THE REPORTED EVENT. THE BLOOD LOSS WAS ATTRIBUTED TO THE PATIENT¿S INABILITY TO MANUALLY PUMP THE BLOOD BACK AND NOT RELATED TO A MACHINE MALFUNCTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7558725 ↗
• MalfunctionJan 29, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  A BIOMEDICAL ENGINEER (BIOMED) REPORTED THAT A HOME HEMODIALYSIS (HD) PATIENT WAS HAVING ISSUES RETURNING THEIR BLOOD AT THE END OF HD TREATMENT WHILE USING A FRESENIUS 2008K@HOME HD MACHINE. THE PATIENT REPORTEDLY WAS UNABLE TO RETURN HIS BLOOD AT THE END OF TREATMENT WHEN THE MESSAGE ¿TX DISCONNECT?¿ APPEARED ON THE MACHINE FOR RE-INFUSION. THE ESTIMATED BLOOD LOSS WAS 100ML. THERE WAS NO PATIENT INJURY OR ADVERSE REACTION REPORTED. NO MEDICAL INTERVENTION WAS REQUIRED. FOLLOWING THE EVENT, THE BIOMED EVALUATED THE MACHINE AT THE PATIENT¿S HOME. THE BIOMED REPLACED THE BLOOD PUMP AND THE AIR DETECTOR, AND RESEATED AND THE CARD CAGE BOARDS. THE PATIENT CONTINUES TO USE THE MACHINE AND DID NOT MISS ANY TREATMENTS OR HAVE ANY FURTHER ISSUES. NO PARTS ARE REPORTED TO BE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR ANALYSIS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7224739 ↗
• MalfunctionAug 7, 2017Contamination /Decontamination Problem; Contamination /Decontamination Problem

  A HOME HEMODIALYSIS (HD) THERAPIES NURSE REPORTED THAT A HOME HD PATIENT IS SWITCHING TO THE NXSTAGE MACHINE DUE TO MULTIPLE ISSUES OBSERVED WHILE USING THE FRESENIUS 2008K@HOME MACHINE FOR POSITIVE CULTURE TEST RESULTS, RESULTING IN THE PATIENT HAVING BACK-UP TREATMENT AT A DIALYSIS CLINIC. THE NURSE STATED THAT THE CLINICS ARE FULL AND SOMETIMES THE PATIENT WOULD HAVE TO DRIVE OVER AN HOUR AWAY TO GET TREATMENT. THE PATIENT REPORTEDLY LIVES IN A REMOTE AREA AND WORKS FULL TIME, CAUSING INCONVENIENCE. IN ADDITION, THE PATIENT¿S MEDICAL DOCTOR (MD) HAS INSTRUCTED THAT THE PATIENT COMPLETE HD TREATMENT EITHER FOUR (4) DAYS PER WEEK FOR FOUR (4) HOURS, OR THREE (3) DAYS A WEEK FOR FIVE (5) HOURS FIFTEEN (15) MINUTES ON THE 2008K@HOME MACHINE. THE MD ALLOWS FOR THE PATIENT TO RUN EXTRA TREATMENTS AS NEEDED, AS THE PATIENT HAS SEVERE LYMPHEDEMA, CURRENT WEIGHT OF APPROXIMATELY (B)(6), AND IS SHORT OF BREATH THE MAJORITY OF THE TIME AND MAY NEED ADDITIONAL FLUID REMOVAL. THE MD WOULD PREFER THAT THE PATIENT COMPLETE HD TREATMENT EVERY DAY, HOWEVER, THE PATIENT DENIES TO COMPLY WITH THESE INSTRUCTIONS. IN ADDITION, THE PATIENT HAS DIFFICULTY SITTING LONG ENOUGH TO COMPLETE A 5 HOURS 15 M

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6771556 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K070049, K150708. One submission often covers many models, so check the product and lot details in each record.

• Z-0033-2024 · Sep 6, 2023 · Open, Classified
  2008T HD SYS. CDX W/BIBAG BLUESTAR
• 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-0029-2024 · Sep 6, 2023 · Open, Classified
  2008T Hemodialysis System without CDX
• Z-0031-2024 · Sep 6, 2023 · Open, Classified
  2008T GEN 2 Bibag without CDX
• Z-0034-2024 · Sep 6, 2023 · Open, Classified
  2008T HD SYS. W/O CDX BLUESTAR
• Z-0028-2024 · Sep 6, 2023 · Open, Classified
  2008T Hemodialysis SYS, with CDX
• Z-0035-2024 · Sep 6, 2023 · Open, Classified
  2008T HD SYS. W/O CDX W/BIBAG BLUESTAR
• Z-1026-2017 · Dec 21, 2016 · Terminated
  Fresenius 2008T Series Hemodialysis System
• Z-1028-2017 · Dec 21, 2016 · Terminated
  Fresenius 2008K2 Series : Hemodialysis System
• Z-1029-2017 · Dec 21, 2016 · Terminated
  Fresenius 2008K@home Series : Hemodialysis System
• Z-1027-2017 · Dec 21, 2016 · Terminated
  Fresenius 2008K Series : Hemodialysis System
• Z-1549-2015 · Feb 20, 2015 · Terminated
  2008 Series Hemodialysis Machines: 2008Kathome - 190895 2008T GEN 2 BIBAG WITHOUT CDX; 190908 2008T HD SYSTEM WITH CDX, CANADA; 190713 2008T HEMODIALYSIS SYS., with CDX; 190766 200
• Z-0629-2014 · Nov 12, 2013 · Terminated
  Fresenius 2008 Series Hemodialysis Machines: Models: 2008H, 2008K, 2008K2, 2008k@Home, 2008T The 2008H Hemodialysis machine is indicated for acute and chronic dialysis therapy. He
• Z-0186-2014 · Aug 29, 2013 · Terminated
  Combiset Blood Line Hemodialysis use Catalog Number: 03-2622-3. Intended for use as the extracorporeal blood circuit during Hemodialysis and is indicated for use with conventiona

…and 4 more.