BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARTRIDGE

    MDR report key: 3848029 · Received June 4, 2014

    Report

    Report Number
    8030638-2014-00007
    Event Type
    Injury
    Date Received
    June 4, 2014
    Date of Event
    May 5, 2014
    Report Date
    June 4, 2014
    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
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE BLOOD TUBING SET INVOLVED IN THE INCIDENT WAS EVALUATED AND THE CONCLUSION IS AS FOLLOW: THE VENOUS LUER CONE FROM THE BLOOD TUBING SET DID NOT HAVE ANY CRACKS. THE VENOUS LUER LOCKING COLLAR THREADS HAD NO CRACKS. VENOUS LUER CONNECTOR OF THE BLOOD TUBING SET ARE IN COMPLIANCE WITH THE ISO STANDARD 594/1 AND 594/2. 15 UNUSED CARTRIDGE BLOOD SETS FROM THE REPORTED LOT NUMBER 1000079632 WERE INSPECTED FOR POSSIBLE PHYSICAL CHARACTERISTICS THAT MAY CONTRIBUTED TO LOOSING CONNECTIONS. THE VISUAL INSPECTION MADE AND THE LEAK TEST COMPLETED FOR THE BLOODLINE DID NOT IDENTIFY ANY CONDITION OUTSIDE THE PRODUCT PREDETERMINED VALIDATED SPECIFICATIONS. THERE ARE NO CONDITIONS PRESENT IN THE BLOOD TUBING SET THAT MAY HAVE AID FOR A LOOSE CONNECTION OR A LEAK. GAMBRO HAS FOUND NO EVIDENCE TO SUGGEST THAT ANY GAMBRO DEVICE CAUSED OR CONTRIBUTED TO THIS EVENT. GAMBRO DOES NOT REGARD THE SUBMITTAL OF THIS REPORT AS AN ADMISSION OF CAUSATION OR LIABILITY.

    Description of Event or Problem · 1

    A PATIENT IN THE ICU, POST MYOCARDIAL INFARCTION, EXPERIENCED WORSENING OF HIS STAGE III CKD AND REQUIRED HENDIADYS. APPROXIMATELY TWO MINUTES AFTER STARTING THE DIALYSIS TREATMENT, THE NURSE OBSERVED BLOOD LEAKING FROM AROUND THE VENOUS LINE CONNECTOR AND TEGO ADAPTER/CONNECTOR. THE NURSE STOPPED THE BLOOD PUMP AND ATTEMPTED TO TIGHTEN THE CONNECTION WITHOUT SUCCESS. WHILE THE NURSE WAS TRYING TO RETURN THE BLOOD, THE PATIENT CODED AND SUCCESSFULLY RESUSCITATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325930 CARTRIDGE SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE FJK GAMBRO RENAL PRODUCTS S.A. DE C.V. 1000079632

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention PHOENIX SN (B)(4) SWV 3.36.02, REVACLEAR,BICART720