BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 4201040 · Received October 27, 2014

    Report

    Report Number
    1416980-2014-37389
    Event Type
    Malfunction
    Date Received
    October 27, 2014
    Date of Event
    September 24, 2014
    Report Date
    September 30, 2014
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FRN
    PMA / PMN Number
    K905713
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: BAXTER RECEIVED THE SAMPLE FOR EVALUATION. DURING VISUAL INSPECTION THE PUMP SEGMENT ASSEMBLY WAS OBSERVED TO BE DAMAGED. FUNCTIONAL TESTING FAILED BECAUSE THE PUMP SEGMENT WAS DAMAGED AND COULD NOT CONNECT TO THE PUMP. THE CAUSE COULD NOT BE DETERMINED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED AND THE EVALUATION IS IN PROGRESS. UPON COMPLETION OF THE INVESTIGATION, OR IF ANY ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TUBING WAS ¿BROKEN¿ ON AN EPIDURAL SPIKE SET. THIS WAS NOTED BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681258 ACCESS PUMP, INFUSION FRN BAXTER HEALTHCARE - AIBONITO UR13G30163

    Patients

    Seq Age Sex Outcome Treatment
    1