BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERMATE

    MDR report key: 2874456 · Received December 14, 2012

    Report

    Report Number
    1416980-2012-07428
    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 FOR EVALUATION. THE REPORTED CONDITION WAS CONFIRMED. VISUAL EXAMINATION OF THE UNIT SHOWED A BROKEN STRESS MEMBER FLANGE. THE CAUSE OF THE BROKEN FLANGE WAS DUE TO EXCESSIVE FORCE DURING THE STUFFING PROCESS AT THE AUTOMATIC BLADDER STUFFER CAPPING MACHINE. NO REPAIR WAS DONE, AS THIS IS A SINGLE-USE DEVICE WHICH WILL BE DISCARDED. NO OTHER OBSERVATIONS WERE NOTED ON THE UNIT.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BAXTER (B)(4) AN INTERMATE WHERE THE FILL PORT AND THE CAP AROUND THE FILL PORT WERE OBSERVED TO BE BROKEN. THE DEVICE WAS FILLED WITH ANTIBIOTIC DRUGS. 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 11H007

    Patients

    Seq Age Sex Outcome Treatment
    1