BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2852927 · Received November 30, 2012

    Report

    Report Number
    1416980-2012-06253
    Event Type
    Malfunction
    Date Received
    November 30, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 6, 2012
    Manufacturer
    BAXTER HEALTHCARE - MALTA
    Product Code
    BRZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE CUSTOMER REPORTED CONDITION OF A SURGICAL BLOOD ADMINISTRATION SET THAT "SHOWED LOOSE COMPONENTS" WAS CONFIRMED DURING SAMPLE EVALUATION. ONE ACTUAL SAMPLE WAS AVAILABLE AT THE PLANT FOR EVALUATION. VISUAL INSPECTION REVEALED THAT THE SET'S BLOOD HAND PUMP HAD THE TUBE DISCONNECTED. NO OTHER TESTS WERE PERFORMED. THE ASSIGNABLE ROOT CAUSE OF THE REPORTED CONDITION IS UNKNOWN. ADDITIONAL INFORMATION: A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THIS IS A PRODUCT NOT DISTRIBUTED IN THE US AND DOES NOT HAVE A 510(K) NUMBER. SHOULD ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FACILITY CONTACTED BAXTER (B)(4) TO REPORT A SURGICAL BLOOD ADMINISTRATION SET THAT "SHOWED LOOSE COMPONENTS". THIS CONDITION WAS FOUND BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT, NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE EVENT IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS SET, BLOOD TRANSFUSION BRZ BAXTER HEALTHCARE - MALTA 12D17V182

    Patients

    Seq Age Sex Outcome Treatment
    1