BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GAMBRO CARTRIDGE BLOOD SET

    MDR report key: 2960311 · Received February 8, 2013

    Report

    Report Number
    8030638-2013-00002
    Event Type
    Injury
    Date Received
    February 8, 2013
    Date of Event
    December 27, 2012
    Report Date
    January 11, 2013
    Manufacturer
    GAMBRO RENAL PRODUCTS S.A. DE C.V.
    Product Code
    FJK
    PMA / PMN Number
    K070414
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BLOOD TUBING SET INVOLVED IN THIS INCIDENT WAS NOT AVAILABLE FOR INVESTIGATION. INSTEAD, ONE HUNDRED COMPANION SAMPLES FROM THE SAME LOT NUMBER REPORTED (1000027119) WERE VISUALLY INSPECTED. FOUR BLOOD TUBING SETS WERE FOUND TO HAVE DISTORTED PUMP SEGMENTS. THOSE FOUR BLOOD TUBING SETS WERE FUNCTIONAL TESTED FOR HOURS ON A PHOENIX DIALYSIS MACHINE AND IN EACH CASE; THE PUMP SEGMENT CAME OFF THE PUMP ROTOR. THE INVOLVED BLOOD TUBING SET DOES NOT HAVE FDA CLEARANCE AND IS NOT MARKETED IN THE USA. THE BLOOD TUBING SET IS SIMILAR TO ANOTHER GAMBRO BLOOD TUBING SET WHICH IS SOLD IN THE U.S. BUT THE ISSUE IS NOT PRESENT IN THAT SET.

    Description of Event or Problem · 1

    DURING TREATMENT, TWO BLOOD TUBING SETS REPORTEDLY CAME OFF THE BLOOD PUMP ROTOR; TREATMENT WAS STOPPED AND THE BLOOD IN THE EXTRACORPOREAL CIRCUITS WAS NOT RETURNED TO THE PT. THE PT HAD AN ESTIMATED BLOOD LOSS OF 800 ML. THE PT'S VITAL SIGNS REMAINED STABLE, THE DIALYSIS TREATMENT COMPLETED AND THE PT WAS DISCHARGED HOME. WHEN THE PT RETURNED FOR HER NEXT SCHEDULED DIALYSIS TREATMENT HER LAB WORK REVEALED HER HEMOGLOBIN DECREASED. THE PHYSICIAN ORDERED AN INCREASED DOSE OF EPOGEN. IT WAS REPORTED THE PT'S HEMOGLOBIN INCREASED FOLLOWING THE DOSE OF EPOGEN. THE PHOENIX MACHINE WAS INSPECTED AND FOUND TO BE OPERATING AS INTENDED. THE BLOOD TUBING SETS WERE DISCARDED AND NOT AVAILABLE FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53600 GAMBRO CARTRIDGE BLOOD SET BLOOD TUBING SET FJK GAMBRO RENAL PRODUCTS S.A. DE C.V. NA 1000027119

    Patients

    Seq Age Sex Outcome Treatment
    1 Other PHOENIX DIALYSIS MACHINE| BAXTER EXELTRA (E210)