BEUDAMED
    FDA Adverse Event Death Summary report: N

    EXTRACORPOREAL CUSTOM TUBING PACK

    MDR report key: 6832 · Received September 24, 1993

    Report

    Report Number
    34694-1993-00001
    Event Type
    Death
    Date Received
    September 24, 1993
    Date of Event
    July 6, 1993
    Report Date
    July 20, 1993
    Manufacturer
    GISH BIOMEDICAL
    Product Code
    LLB
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE REPORT INDICATED THAT A PATIENET ON A PEDIATRIC ECMO CIRCUIT EXPIRED AFTER A FAILURE IN THE CUSTOM ECMO CIRCUIT. CAUSE OF DEATH HAD NOT BEEN INDICATED AS OF THIS DATE.DEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: CRITICAL CONDITION. 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.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: NONE OR UNKNOWN. RESULTS OF EVALUATION: NONE OR UNKNOWN. CONCLUSION: NONE OR UNKNOWN. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: UNKNOWN (CANNOT DETERMINE). CORRECTIVE ACTIONS: NONE OR UNKNOWN. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTRACORPOREAL CUSTOM TUBING PACK CUSTOM TUBING PACK LLB GISH BIOMEDICAL N/A 028307

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Death