BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3031147 · Received April 2, 2013

    Report

    Report Number
    3004209178-2013-04483
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Report Date
    March 5, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-0591-2009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8731, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S LOW RESERVOIR ALARM WENT OFF ABOUT FIVE DAYS PRIOR TO REPORT. THE PATIENT BEGAN EXPERIENCING WITHDRAWAL CHARACTERIZED BY FLU-LIKE SYMPTOMS ABOUT THREE DAYS PRIOR TO REPORT. IT WAS STATED THAT THE PHYSICIAN HAD INCREASED THE INFUSION RATE, BUT DID NOT LET THE REFILLING HEALTHCARE PROFESSIONAL KNOW. UPON ACCESSING THE RESERVOIR, ONLY 0.7ML WAS FOUND. IN ADDITION TO THE LOW RESERVOIR, INTERROGATION DISPLAYED A MESSAGE FOR A MOTOR STALL. IT WAS STATED THAT THE PATIENT HAD AN MRI ON THE PREVIOUS DAY. THE PUMP WAS RE-INTERROGATED AND THE PUMP LOGS WERE READ. THE LOGS SHOWED THAT THE MOTOR STALL HAD OCCURRED AT 12:09PM ON THE PREVIOUS DAY WITH THE RECOVERY OCCURRING AT 2:31 PM ON THE DAY OF REPORT. IT WAS REPORTED THAT THE PUMP HAD NOT BEEN CHECKED AFTER THE MRI. ON THE NEXT DAY, IT WAS REPORTED THAT 'EVERYTHING WAS GOOD' FOLLOWING THE REFILL. THE DRUG USED IN THIS SYSTEM WAS MORPHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134501 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1