BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED VOLUMETRIC PUMP SET

    MDR report key: 1842189 · Received September 23, 2010

    Report

    Report Number
    6000001-2010-03481
    Event Type
    Malfunction
    Date Received
    September 23, 2010
    Date of Event
    August 27, 2010
    Report Date
    August 27, 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

    THE SAMPLE IS AVAILABLE FOR EVALUATION AND PENDING RECEIPT BY (B)(4). A FOLLOW UP REPORT WILL BE FILED IF THE SAMPLE IS RETURNED AND EVALUATED OR IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE. THIS PRODUCT IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE U.S. AND DOES NOT HAVE A 510K NUMBER. THIS INCIDENT IS BEING REPORTED BECAUSE THE PRODUCT IS THE SAME AS OR SIMILAR TO PRODUCT DISTRIBUTED WITHIN THE U.S. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER RETURNED THE ACTUAL SAMPLE FOR EVALUATION. THE SAMPLE WAS PRESSURE TESTED AT 8 PSI AND THE REPORTED CONDITION WAS NOT CONFIRMED; THEREFORE, AN ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED. A BATCH REVIEW WAS PERFORMED ON THE REPORTED LOT WITH NO DEVIATIONS FOUND. THIS IS REPORT IS 2 OF 5 OF THE SAME REPORTED PROBLEM FROM THIS FACILITY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER (B)(4) ON (B)(6) 2010, AN INCIDENT WHERE THE SET WAS LEAKING WHILE IN USE WITH THE VENTED VOLUMETRIC PUMP SET. THIS INCIDENT OCCURRED AT AN UNKNOWN TIME. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1