BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERMATE

    MDR report key: 2963894 · Received February 15, 2013

    Report

    Report Number
    1416980-2013-03950
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    January 21, 2013
    Report Date
    January 22, 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). EVALUATION SUMMARY: BAXTER RECEIVED ONE SAMPLE FOR EVALUATION. A VISUAL EXAMINATION DID NOT SHOW ANY SIGNS OF A RUPTURE. HOWEVER, THERE WAS BROKEN TUBING FOUND AT THE LUER POST JUNCTION. THEREFORE THE REPORTED RUPTURE WAS NOT CONFIRMED, AS THE LEAK WAS DETERMINED TO BE CAUSED BY THE BROKEN TUBING. NO REPAIR WAS DONE, AS THIS IS A SINGLE-USE DEVICE WHICH WILL BE DISCARDED. NO OTHER OBSERVATIONS WERE NOTED ON THE SAMPLE. ADDITIONAL INFORMATION: 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.

    Description of Event or Problem · 1

    BAXTER (B)(4) RECEIVED A REPORT THAT AN INTERMATE HAD LEAKED UPON UNPACKING. ACCORDING TO THE CUSTOMER, THE RESERVOIR OF THE DEVICE WAS NOTED TO HAVE POPPED AND THE FLUID HAD LEAKED OUT OF THE DEVICE. THE DEVICE WAS FILLED WITH SOLUTION OF NACL. THERE WAS NO PATIENT INVOLVEMENT; THEREFORE, NO PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE REACTION IS ASSOCIATED WITH THE REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67669 INTERMATE PUMP, INFUSION FRN BAXTER HEALTHCARE - IRVINE 12F078

    Patients

    Seq Age Sex Outcome Treatment
    1