BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GAMBRO CARTRIDGE BLOOD SET

    MDR report key: 1691399 · Received April 20, 2010

    Report

    Report Number
    8030638-2010-00002
    Event Type
    Injury
    Date Received
    April 20, 2010
    Date of Event
    March 20, 2010
    Report Date
    March 22, 2010
    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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO REASON HAS BEEN FOUND TO SUSPECT THAT A GAMBRO PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT. THE CLINIC IS CONDUCTING AN INTERNAL INVESTIGATION AND, IF THAT INVESTIGATION REVEALS NEW INFO, THE CLINIC HAS INDICATED IT WILL RETURN THE DIALYZER AND BLOOD LINES USED IN THE TREATMENT TO THE MFRS FOR FURTHER ANALYSIS. THE PHOENIX MACHINE WAS INSPECTED BY A GTS REPRESENTATIVE, WHO FOUND IT TO BE CALIBRATED WITHIN MFR'S SPECIFICATIONS.

    Description of Event or Problem · 1

    APPROXIMATELY TWENTY-FIVE MINUTES INTO A HEMODIALYSIS TREATMENT, THE PT'S BLOOD PRESSURE DROPPED AND SHE BECAME UNRESPONSIVE. SHE WAS FOUND TO HAVE NO PULSE, AND CARDIOPULMONARY RESUSCITATION WAS INITIATED. SHE WAS SUCCESSFULLY RESUSCITATED, INTUBATED, AND TRANSFERRED TO THE MICU. HER ADMITTING DIAGNOSIS WAS "CARDIAC ARREST - CAUSE UNKNOWN". IN THE PAST, THE PT HAS EXPERIENCED SIMILAR EVENTS WHILE ON DIALYSIS. NEITHER THE NURSES, NOR THE PHYSICIANS CARING FOR THE PT BELIEVE THAT THE PHOENIX MACHINE CAUSED OR CONTRIBUTED TO THE PT'S CARDIAC EVENT. THE PT HAS RESUMED DIALYSIS IN THE CLINIC.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| R PHOENIX MACHINE, (B) (4), SW 3.35| FRESENIUS OPTIFLUX F180NR| BICART 1250 LOT NUMBER UNK