BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 4841352 · Received June 12, 2015

    Report

    Report Number
    1416980-2015-25075
    Event Type
    Malfunction
    Date Received
    June 12, 2015
    Report Date
    May 18, 2015
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    BRZ
    PMA / PMN Number
    K993120
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED FOR EVALUATION. DURING VISUAL INSPECTION, THE TUBING OF THE DEVICE WAS OBSERVED TO BE SEPARATED FROM THE DRIP CHAMBER. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE CAUSE OF THE CONDITION COULD NOT BE DETERMINED. A CAPA HAS BEEN OPENED TO ADDRESS THIS ISSUE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TUBING OF A CLEARLINK BLOOD SET DETACHED FROM THE BLOOD CHAMBER. THIS OCCURRED DURING SET-UP. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384506 ACCESS SET, BLOOD TRANSFUSION BRZ BAXTER HEALTHCARE R13J05079

    Patients

    Seq Age Sex Outcome Treatment
    1