BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARTRIDGE

    MDR report key: 3781963 · Received April 30, 2014

    Report

    Report Number
    8030638-2014-00006
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    April 9, 2014
    Report Date
    April 30, 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
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE BLOOD TUBING SET INVOLVED IN THIS INCIDENT WAS NOT AVAILABLE FOR INVESTIGATION AND THE LOT NUMBER COULD NOT BE PROVIDED BY THE FACILITY.

    Description of Event or Problem · 1

    LIMITED INFORMATION HAS BEEN PROVIDED FOR THIS EVENT OTHER THAN THE PATIENT HAD A CARDIAC HISTORY AND EXPERIENCED AN EPISODE DURING TREATMENT THAT RESULTED IN HOSPITALIZATION. THE CLINICIAN AT THE HOSPITAL STATES THAT THIS INCIDENT WAS NOT PRODUCT RELATED. THE PHOENIX MACHINE WAS INSPECTED AND DETERMINED TO BE OPERATING WITHIN SPECIFICATION. THE CARTRIDGE BLOOD LINE WAS NOT AVAILABLE FOR INSPECTION AND THE THE BICART WAS DISCARDED AND NOT AVAILABLE FOR INSPECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259228 CARTRIDGE SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE FJK GAMBRO RENAL PRODUCTS S.A. DE C.V. NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization PHOENIX SN: (B)(4), BICART