BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2243621-1992-00096

    MDR report key: 1232 · Received August 27, 1992

    Report

    Report Number
    2243621-1992-00096
    Event Type
    Injury
    Date Received
    August 27, 1992
    Date of Event
    July 30, 1992
    Report Date
    August 17, 1992
    Manufacturer
    GAMBRO PLATE DIALYZER
    Product Code
    KDI
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    DC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    UNIT ALLEGES BLOOD HEAD ON GAMBRO PLATE FOR DIALYZER. PATIENT ON HEMODIALYSIS MACHINE 10 MINUTES AND MACHINE ALARMED. BLD IN DIALYSATE (+) PER HCP. BLOOD NOT RETURNED TO PATIENT EBL 250CC PER HCP. LOSS OF DIALYZER AND BROKEN VENOSET ARTERIAL LINESDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS NOT EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: NO DATA. RESULTS OF EVALUATION: NO DATA. CONCLUSION: NO DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: NO DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KDI GAMBRO PLATE DIALYZER 1-0589-N-11

    Patients

    Seq Age Sex Outcome Treatment
    1 Other