BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERMATE

    MDR report key: 3180528 · Received June 20, 2013

    Report

    Report Number
    1416980-2013-16011
    Event Type
    Malfunction
    Date Received
    June 20, 2013
    Report Date
    May 28, 2013
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    FRN
    PMA / PMN Number
    K910425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS RECEIVED BY BAXTER FOR EVALUATION. INITIAL INSPECTION DID NOT FIND EVIDENCE OF A MALFUNCTION OF THE INTERMATE DEVICE. UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). VISUAL INSPECTION DID NOT IDENTIFY ANY PHYSICAL ABNORMALITIES WITH THE DEVICE. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE EVALUATION COULD NOT CONFIRM THE REPORTED CONDITION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INTERMATE SV200 BROKE. THIS OCCURRED WHILE FILLING THE DEVICE USING A NON-BAXTER PUMP SET. THERE WAS NO PATIENT INVOLVEMENT REPORTED. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280066 INTERMATE PUMP, INFUSION FRN BAXTER HEALTHCARE - IRVINE 13A027

    Patients

    Seq Age Sex Outcome Treatment
    1