BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIFLOW

    MDR report key: 602 · Received May 22, 1992

    Report

    Report Number
    602
    Event Type
    Injury
    Date Received
    May 22, 1992
    Date of Event
    May 5, 1992
    Report Date
    May 6, 1992
    Manufacturer
    BAXTER
    Product Code
    BXO
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    THE PLASTIC LOCK ON THE TRANSDUCER FRACTURED/LEAKED AND THE PUMP FILLED THE BED WITH BLOOD. THE PATIENT HAD TO BE TRANSFUSEDDEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. 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: VISUAL EXAMINATION. RESULTS OF EVALUATION: COMPONENT FAILURE, TELEMETRY FAILURE. CONCLUSION: INVALID 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 UNIFLOW DISPOSABLE PRESSURE TRANDUCERS BXO BAXTER 43-12N 2B0183-SJ2B2748

    Patients

    Seq Age Sex Outcome Treatment
    1 0 MO Required Intervention