BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERMATE

    MDR report key: 2874470 · Received December 14, 2012

    Report

    Report Number
    1416980-2012-07430
    Event Type
    Malfunction
    Date Received
    December 14, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 21, 2012
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    FRN
    PMA / PMN Number
    K910425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: BAXTER RECEIVED ONE SAMPLE CONTAINING FLUID IN THE HOUSING. THE REPORTED CONDITION OF A LEAK WAS CONFIRMED. VISUAL EXAMINATION OF THE UNIT DETERMINED THAT THE ROOT CAUSE OF THE LEAK WAS MISSING FILM WRAP, INDICATING THAT THE DEVICE WAS MISASSEMBLED. THE MISASSEMBLED CONDITION WAS DUE TO AN EQUIPMENT MALFUNCTION AND OPERATOR ERROR DURING THE FILM WRAP ASSEMBLY PROCESS. NO REPAIR WAS DONE, AS THIS IS A SINGLE-USE DEVICE WHICH WILL BE DISCARDED. NO OTHER OBSERVATIONS WERE NOTED ON THE UNIT. 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). THE SAMPLE WAS RECEIVED FOR EVALUATION; HOWEVER, THE EVALUATION HAS NOT YET BEEN COMPLETED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF EVALUATION OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL EVALUATION CONFIRMED THE REPORTED CONDITION. UPON COMPLETION OF BAXTER'S INVESTIGATION, A FOLLOW-UP WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BAXTER (B)(4) AN INTERMATE WHERE THE DILUENT WAS OBSERVED TO BE LEAKING INTO THE HOUSING. THE ALLEGED DEFECT WAS OBSERVED DURING FILLING. THEREFORE, THERE WERE NO REPORTS OF PATIENT INVOLVEMENT, PATIENT INJURY, ADVERSE EVENTS, OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERMATE PUMP, INFUSION FRN BAXTER HEALTHCARE - IRVINE 11N063

    Patients

    Seq Age Sex Outcome Treatment
    1