BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STANDARD AVF NEEDLE

    MDR report key: 4916525 · Received July 15, 2015

    Report

    Report Number
    8041145-2015-00042
    Event Type
    Injury
    Date Received
    July 15, 2015
    Date of Event
    September 29, 2012
    Report Date
    July 15, 2015
    Manufacturer
    NIPRO THAILAND CORPORATION LTD
    Product Code
    FIE
    PMA / PMN Number
    K955182
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER INVESTIGATION REPORT: DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    DURING HEMODIALYSIS TREATMENT, VENOUS NEEDLE DETACHED FROM THE RIGHT SHUNT ARM OF A PATIENT WHICH RESULTED IN APPROXIMATELY 500-1000ML OF BLOOD LOSS. THE PATIENT LOST CONSCIOUSNESS, STAFF STARTED CARDIOPULMONARY REANIMATION FOR 1-2 MINUTES, PATIENT REGAINED CONSCIOUSNESS AND WAS SENT TO IMC UNIT. (NO FURTHER INFORMATION WAS PROVIDED FOR THE DATE OF THIS INCIDENT) ON (B)(6) 2012 HEMODIALYSIS TREATMENT WAS PERFORMED ON A HEMODIALYSIS INSTRUMENT FROM (B)(4). THE INSTRUMENT ISSUED AN ALARM AT THE END OF THE TREATMENT WHILE READY FOR PATIENT'S DISCONNECTION. APPARENTLY NO ALARM WAS TRIGGERED DUE TO THE BLOOD LOSS. (NO FURTHER INFORMATION WAS PROVIDED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459785 STANDARD AVF NEEDLE AVF NEEDLE FIE NIPRO THAILAND CORPORATION LTD 15R20GA15 11C30

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization