BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERMATE

    MDR report key: 2240102 · Received September 9, 2011

    Report

    Report Number
    6000001-2011-23443
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 15, 2011
    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). THE DEVICE IS AVAILABLE FOR EVALUATION PER THE CUSTOMER; HOWEVER, THE DEVICE HAS NOT YET BEEN RECEIVED BY BAXTER. 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 INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: BAXTER RECEIVED ONE SAMPLE CONTAINING APPROXIMATELY 70 ML OF SOLUTION IN THE RESERVOIR. THE TUBING WAS CLAMPED. THE REPORTED CONDITION OF NO FLOW WAS CONFIRMED. VISUAL EXAMINATION OF THE DEVICE SHOWED NO SIGNS OF BLOCKAGE IN THE DELIVERY TUBING THAT COULD HAVE CAUSED THE REPORTED CONDITION. A FUNCTIONAL TEST WAS ATTEMPTED ON THE UNIT, BUT FLOW WAS NOT OBSERVED AT THE DISTAL LUER UNTIL APPROXIMATELY 30 MINUTES AFTER THE TUBING WAS UNCLAMPED. THE ROOT CAUSE WAS DETERMINED TO BE TEMPORARY KINKING OF THE TUBING AFTER PROLONGED USAGE OF THE SLIDE CLAMP. A NEW PART WILL BE IMPLEMENTED IN Q3 2012 TO PREVENT THIS FAILURE MODE. NO OTHER OBSERVATIONS WERE NOTED ON THE UNIT. NO REPAIR WAS DONE, AS THIS IS A SINGLE-USE DEVICE WHICH WILL BE DISCARDED. 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 DID NOT INFUSE DURING PATIENT TREATMENT. THE DEVICE WAS FILLED WITH A 75-ML SOLUTION OF 4.5 MG TAZOCIN IN SALINE. THIS CONDITION HAS THE POTENTIAL TO INTERRUPT THERAPY. THERE WAS PATIENT INVOLVEMENT, BUT THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION NECESSARY, OR ADVERSE REACTION IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERMATE PUMP, INFUSION FRN BAXTER HEALTHCARE - IRVINE 11E027

    Patients

    Seq Age Sex Outcome Treatment
    1 TAZOCIN| SALINE