BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERMATE

    MDR report key: 3200746 · Received July 1, 2013

    Report

    Report Number
    1416980-2013-16974
    Event Type
    Malfunction
    Date Received
    July 1, 2013
    Date of Event
    April 25, 2013
    Report Date
    June 7, 2013
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    FRN
    PMA / PMN Number
    K910425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. BAXTER RECEIVED ONE SAMPLE FOR EVALUATION. VISUAL EXAMINATION OF THE UNIT DETERMINED THAT THE RESERVOIR RUPTURED IN A FOOTED POSITION. THE RESERVOIR WAS ALSO MICROSCOPICALLY EXAMINED FOR ANY ABNORMALITIES THAT MAY HAVE POTENTIALLY CONTRIBUTED TO THE RUPTURE. MARKINGS ON THE INTERIOR SURFACE OF THE RESERVOIR WERE DETECTED NEAR THE RUPTURE LINE. THE CAUSE OF THIS EVENT COULD NOT BE DETERMINED. NO OTHER OBSERVATIONS WERE NOTED ON THE UNIT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ANY ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INTERMATE HAD ITS RESERVOIR RUPTURE NEAR THE END OF INFUSION. THE DEVICE WAS FILLED WITH A SOLUTION OF AMIKLIN. 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
    299598 INTERMATE PUMP, INFUSION FRN BAXTER HEALTHCARE - IRVINE 12E068

    Patients

    Seq Age Sex Outcome Treatment
    1 AMIKLIN