BEUDAMED
    FDA Adverse Event Death Summary report: N

    MAHURKAR-DUAL LUMEN CATHETER

    MDR report key: 1138 · Received August 18, 1992

    Report

    Report Number
    1138
    Event Type
    Death
    Date Received
    August 18, 1992
    Date of Event
    July 3, 1992
    Report Date
    July 28, 1992
    Manufacturer
    QUINTON INSTRUMENT CO.
    Product Code
    DXG
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    ABNORMAL COAGULATION STUDIES FOLLOWING DIALYSIS/PHERSIS. POSSIBILITY OF INADVERTENT INJECTION OF HEPARIN THROUGH LUMEN. THIS MAY HAVE CONTRIBUTED TO PATIENT'S DEATHINVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: CRITICAL CONDITION. THERE WAS MULTIPLE PATIENT INVOLVEMENT. NUMBER OF PATIENTS INVOLVED: 2.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 EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: A DEVICE FROM SAME LOT WAS EVALUATED, OTHER. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: NONE OR UNKNOWN, OTHER. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: OTHER. THE DEVICE WAS DESTROYED/DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAHURKAR-DUAL LUMEN CATHETER CENTRAL VENOUS CATHETER DXG QUINTON INSTRUMENT CO. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Death