BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GAMBRO CARTRIDGE BLOOD SET

    MDR report key: 1677997 · Received April 30, 2010

    Report

    Report Number
    8030638-2010-00003
    Event Type
    Injury
    Date Received
    April 30, 2010
    Date of Event
    March 17, 2010
    Report Date
    April 1, 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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BLOOD TUBING SET INVOLVED IN THIS INCIDENT WAS DISCARDED AND IS NOT AVAILABLE FOR INVESTIGATION. RETAINED SAMPLES FROM LOT# 12Q158206 WERE VISUALLY INSPECTED, FUNCTIONAL AND DIMENSIONAL TESTING PERFORMED WITH NO FAILURES DETECTED.

    Description of Event or Problem · 1

    DURING THE DIALYSIS TREATMENT THE PT COMPLAINED OF "FEELING FUNNY" AND SHORTNESS OF BREATH. THE PT WAS ADMINISTERED 2L OF OXYGEN PER NASAL CANNULA. HER BLOOD PRESSURE WAS INCREASED TO 223/124 MMHG. SHE WAS BRIEFLY DISCONNECTED FROM TREATMENT TO GO TO THE BATHROOM. FOLLOWING THE DIALYSIS TREATMENT THE PT WAS DISCHARGED HOME. SEVERAL HOURS LATER THE PT WAS ADMITTED TO THE HOSP'S ICU WITH THE DIAGNOSIS OF HEMOLYSIS. WHILE HOSPITALIZED SHE RECEIVED A TRANSFUSION OF ONE UNIT OF BLOOD. HER CONDITION RAPIDLY IMPROVED FOLLOWING THE TRANSFUSION. SHE WAS DISCHARGED FROM THE HOSP AND HAS TRANSFERRED TO ANOTHER OUTPATIENT DIALYSIS UNIT. THE MEDICAL INFO PROVIDED IS LIMITED AND THE ONLY LAB INFO INDICATES THE PT HAD A DROP IN HGB, INCREASED BILIRUBIN LEVEL AND ELEVATED POTASSIUM LEVEL. THE MEDICAL DIRECTOR OF THE UNIT HAD NO ADDITIONAL INFO TO PROVIDE. THE CAUSE OF THE HEMOLYSIS IS NOT KNOWN. THE NURSE REPORTED THAT NO KINKS WERE OBSERVED IN THE TUBING, AND NO UNUSUAL NOISES WERE HEARD FROM THE BLOOD PUMP. THE DIALYZER AND BLOOD TUBING SET HAVE BEEN DISCARDED AND NOT AVAILABLE FOR INVESTIGATION.

    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 12Q158206

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization| R FRESENIUS OPTIFLUX F160 NR, LOT UNK| MEDISYSTEMS, 15 GA| PHOENIX MACHINE, (B) (6), SW 3.35