BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERMATE

    MDR report key: 3112989 · Received May 15, 2013

    Report

    Report Number
    1416980-2013-12340
    Event Type
    Malfunction
    Date Received
    May 15, 2013
    Date of Event
    April 12, 2013
    Report Date
    April 19, 2013
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    FRN
    PMA / PMN Number
    K910425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT NO: (B)(4). A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. INITIAL EVALUATION CONFIRMED THE REPORTED CONDITION. UPON COMPLETION OF BAXTER'S INVESTIGATION, A FOLLOW-UP WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY:BAXTER RECEIVED ONE SAMPLE FOR EVALUATION. VISUAL EXAMINATION OF THE UNIT DETERMINED THAT THE CAUSE OF THE LEAK WAS A RUPTURED RESERVOIR. SOLUTION WAS ALSO NOTED IN THE HOUSING DUE TO THE RUPTURE. THE RESERVOIR WAS MICROSCOPICALLY EXAMINED FOR ANY ABNORMALITIES THAT MAY HAVE POTENTIALLY CONTRIBUTED TO THE RUPTURE. SOME MARKINGS WERE DETECTED NEAR THE RUPTURE LINE INDICATING INTERNAL DAMAGE. THE CAUSE OF THE RUPTURE WAS NOT DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SMALL VOLUME INTERMATE HAD LEAKED DURING FILLING. THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215468 INTERMATE PUMP, INFUSION FRN BAXTER HEALTHCARE - IRVINE 13A052

    Patients

    Seq Age Sex Outcome Treatment
    1