BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMETRA PROGRAMMABLE PUMP

    MDR report key: 3802396 · Received February 21, 2014

    Report

    Report Number
    3006803715-2014-00002
    Event Type
    Malfunction
    Date Received
    February 21, 2014
    Date of Event
    January 24, 2014
    Report Date
    January 24, 2014
    Manufacturer
    FLOWONIX MEDICAL INC.
    Product Code
    LKK
    PMA / PMN Number
    P080012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS BEING EVALUATED AT THE MANUFACTURING SITE. WHEN THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE FILED. INTERNAL COMPLAINT NUMBER COMPLAINT-(B)(4).

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTED A DRUG RESERVOIR VOLUME DISCREPANCY DURING A ROUTINE REFILL VISIT. THE EXPECTED VOLUME WAS 2.5ML, BUT 19ML WAS ASPIRATED. THE PT REPORTED INADEQUATE PAIN RELIEF. ON (B)(6) 2014, THE PT RETURNED FOR A FOLLOW UP. THE EXPECTED VOLUME WAS 13.5ML, BUT 19.0ML WAS ASPIRATED. A FLOWONIX FIELD CLINICAL ENGINEER TRAVELED TO THE SITE BUT COULD NOT VERIFY PROPER PUMP PERFORMANCE. A CATHETER ACCESS PORT (CAP) PROCEDURE WAS PERFORMED AND INDICATED THAT THE CATHETER WAS PATENT AND IN THE CORRECT LOCATION. THE PUMP WAS EXPLANTED ON (B)(6) 2014 AND WAS RETURNED TO FLOWONIX FOR INVESTIGATION. THE DRUGS BEING USED IN THE PUMP WERE MORPHINE AND BUPIVACAINE. IT WAS REPORTED THAT THE PUMP WAS PRIMED IN A WATER BATH PRIOR TO IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110037 PROMETRA PROGRAMMABLE PUMP IMPLANTABLE INFUSION PUMP LKK FLOWONIX MEDICAL INC. 11827

    Patients

    Seq Age Sex Outcome Treatment
    1