BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERMATE

    MDR report key: 3000295 · Received March 12, 2013

    Report

    Report Number
    1416980-2013-05915
    Event Type
    Malfunction
    Date Received
    March 12, 2013
    Report Date
    February 16, 2013
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    FRN
    PMA / PMN Number
    K910425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. SHOULD THE DEVICE BE RECEIVED BY BAXTER FOR EVALUATION, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVALUATION OR IF ANY ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). AFTER FURTHER INVESTIGATION BY BAXTER PERSONAL, IT WAS FOUND THAT THE UNDETERMINED MALFUNCTION WAS PARTICULATE MATTER ON THE BLADDER. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVALUATION OR IF ANY ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE. THE BATCH REVIEW REVEALED THAT ALL OF THE ACCEPTANCE CRITERIA WERE MET TO RELEASE THE LOT. THERE WERE NO NON-CONFORMANCES, FAILURES, REWORK, OR DEVIATIONS RELATED TO THE LOT. THERE WERE NO CHANGES TO SPECIFICATIONS, TEST METHODS, PROCESS, EQUIPMENT, OR RAW MATERIALS THAT COULD BE ASSOCIATED WITH THE REPORTED CONDITION.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: 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. A VISUAL EXAMINATION OF THE UNIT CONFIRMED PARTICULATE MATTER (PM) INSIDE THE HOUSING; HOWEVER, THE PM WAS FOUND OUTSIDE THE FLUID PATH ON THE SURFACE OF THE BLADDER. THE CAUSE OF THE 1.0-MM BLACK LINT PARTICLE WAS DUE TO MANUFACTURING OPERATOR ERROR, DURING THE ASSEMBLY PROCESS. AWARENESS TRAINING WAS ISSUED TO ADDRESS THIS ERROR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO PRODUCT USE, IT WAS NOTED THAT THERE WAS AN UNDETERMINED MALFUNCTION OF THE INTERMATE DEVICE. THERE WAS NO PATIENT INVOLVEMENT; THEREFORE, NO PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE REACTION IS ASSOCIATED WITH THE REPORTED CONDITION. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103337 INTERMATE PUMP, INFUSION FRN BAXTER HEALTHCARE - IRVINE 12B015

    Patients

    Seq Age Sex Outcome Treatment
    1