CombiSet 03-2962-3Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00840861100330), received between Nov 19, 2015 and Apr 8, 2020 — classified as 3 malfunctions.

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

7 other recalls cover devices cleared under the same FDA submission (K070049); 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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 8, 2020Fluid/Blood Leak; Fluid/Blood Leak

  A PATIENT¿S CONTACT REPORTED TO CUSTOMER SERVICE (CS) THAT A COMBI SET BLOOD LEAK OCCURRED AT THE BEGINNING OF THE PATIENT¿S HEMODIALYSIS (HD) TREATMENT. DURING FOLLOW UP, THE CONTACT HAD A DIFFICULT TIME EXPLAINING WHERE THE LEAK WAS COMING FROM. IN ADDITION, THE CONTACT WASN¿T EXACTLY SURE OF THE LEAK ORIGIN. THE BLOOD LOSS WAS REPORTED TO BE MINIMAL; THE CONTACT ESTIMATED ¿ONE OR TWO SPOONFULS¿ OF BLOOD LOSS. NO DAMAGE WAS IDENTIFIED ON THE PRODUCT, AND THERE WERE NO MACHINE ALARMS. THE CONTACT REPORTEDLY CLAMPED THE LINE THAT WAS LEAKING, AND SUCCESSFULLY STOPPED THE LEAK. AFTERWARDS, THE PATIENT COMPLETED THEIR TREATMENT USING THE SAME SUPPLIES. THE CONTACT STATED THERE WAS NO PATIENT INJURY, NO ADVERSE EFFECTS WERE EXPERIENCED, AND NO MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THE REPORTED EVENT. ADDITIONAL INFORMATION WAS OBTAINED DURING FOLLOW UP WITH THE CLINIC MANAGER (CM) AT THE PATIENT¿S USER FACILITY. THE CM CONFIRMED THE PATIENT HADN¿T EXPERIENCED ANY ADVERSE EFFECTS, AND THAT MEDICAL INTERVENTION WAS NOT REQUIRED. THE DETAILS OF THE EVENT WERE NOT ENTIRELY CLEAR TO THE CM. AS THEY UNDERSTOOD IT, THE LEAK WAS COMING FROM THE HEPARIN LINE AS THE PATIENT'S CONTACT

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9935646 ↗
• MalfunctionJul 17, 2017Fitting Problem; Fitting Problem

  A HOME HEMODIALYSIS (HD) THERAPIES NURSE REPORTED THAT APPROXIMATELY THREE HOURS INTO HD TREATMENT, THE SALINE CLAMP ON THE FRESENIUS BLOODLINE HAD BECOME UN-CLAMPED AND CAUSED SALINE TO BE INTRODUCED TO THE HOME HD PATIENT. THE HOME HD MACHINE ALARMED AS EXPECTED FOR AIR DETECTOR AND PREVENTED AIR FROM BEING INTRODUCED TO THE PATIENT. THE PATIENT'S ESTIMATED BLOOD LOSS (EBL) WAS NOTED AS BEING APPROXIMATELY 300 ML (MILLILITERS). THE HD TREATMENT WAS TERMINATED TWO HOURS EARLY. NO PATIENT ADVERSE EFFECTS OR INJURIES WERE EXPERIENCED AND NO MEDICAL INTERVENTION WAS REQUIRED. THE PATIENT HAS CONTINUED REGULARLY SCHEDULED HD THERAPY SESSIONS WITHOUT ANY FURTHER INCIDENTS. THE BLOODLINE DEVICE WAS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER AS IT WAS DISCARDED BY THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6717767 ↗
• 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 5249563 ↗

Recalls under the same FDA submission

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

• 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
• Z-0185-2014 · Aug 29, 2013 · Terminated
  Combiset Blood Line with BVM for Hemodialysis use Catalog Number: 03-2965-9. Intended for use as the extracorporeal blood circuit during Hemodialysis and is indicated for use with
• Z-0184-2014 · Aug 29, 2013 · Terminated
  2008K@ Home Blood lines Combiset True Flow Series for Hemodialysis use Catalog Number: 03-2962-3. Intended for use as the extracorporeal blood circuit during Hemodialysis and is i
• Z-3269-2011 · Aug 11, 2011 · Terminated
  CombiSet True Flow" 2008K@home Bloodlines Fresenius Medical Care. Used for transferring blood during the hemodialysis treatment from the patient to the dialyzer (artificial kidney
• Z-3083-2011 · May 4, 2011 · Terminated
  Fresenius 2008K@home The Fresenius 2008K@home is indicated for acute and chronic dialysis therapy in an acute or chronic facility. The 2008K@home is also indicated for hemodialysi