BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAVH CATHETERS

    MDR report key: 85 · Received February 19, 1992

    Report

    Report Number
    85
    Event Type
    Death
    Date Received
    February 19, 1992
    Date of Event
    January 15, 1992
    Report Date
    January 31, 1992
    Manufacturer
    MEDICAL COMPONENTS, INC.
    Product Code
    EZD
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    ON JANUARY 15, 1992, A PATIENT HAD TWO CATHETERS INSERTED IN PREPARATION FOR C.A.V.H. SHORTLY AFTER CATHETER INSERTION, THE PATIENT BECAME HYPOTENSIVE AND WAS TAKEN TO THE O. R. TO EXPLORE A POSSIBLE BLOOD LOSS. THE PATIENT ARRESTED FOLLOWING SURGERY AND DIED THAT EVENINGINVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. 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. INVALID DATA - WHETHER 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. THE DEVICE WAS DESTROYED/DISPOSED OF.

    Description of Event or Problem · 1

    TWO CATHETERS, ONE VENOUS AND ONE ARTERIAL WERE PLACED FEMORALLY BY PHYSICIAN. SHORTLY AFTER INSERTION COMPLETED, PATIENT BECAME HYPOTENSIVE REQUIRING FLUID AND BLOOD PRODUCTS. PATIENT RETURNED TO OPERATING ROOM FOR EXPLORATION OF POSSIBLE BLOOD LOSS. THE COMMON ILIAC ARTERY WAS REPAIRED. THE PATIENT ARRESTED POST-OPERATIVELY AND DIED THAT EVENINGINVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. 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. INVALID DATA - WHETHER 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. THE DEVICE WAS DESTROYED/DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAVH CATHETERS EZD MEDICAL COMPONENTS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death