BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED VOLUMETRIC PUMP SET

    MDR report key: 1983541 · Received February 10, 2011

    Report

    Report Number
    6000001-2011-00829
    Event Type
    Malfunction
    Date Received
    February 10, 2011
    Date of Event
    May 3, 2010
    Report Date
    May 16, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN ACTUAL SAMPLE WAS SUBMITTED FOR EVALUATION. A VISUAL EXAMINATION OF THE SAMPLE CONFIRMED A LEAK DUE TO A CUT ON THE TUBING. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THIS DEVICE IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT HAVE A US 510K NUMBER. HOWEVER, AN MDR IS BEING SUBMITTED BECAUSE IT IS THE SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE US.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BAXTER (B)(4) OF A VENTED SET THAT HAD A LEAKING ISSUE DURING USE. THERE WAS NO REPORTED PATIENT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTED VOLUMETRIC PUMP SET SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - SINGAPORE S09I14136R

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN SOLUTION