BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3201561 · Received July 2, 2013

    Report

    Report Number
    3004209178-2013-04457
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    January 19, 2012
    Report Date
    January 19, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8840, SERIAL# UNKNOWN, PRODUCT TYPE PROGRAMMER, PHYSICIAN; PRODUCT ID NEU_PTM_PROG, SERIAL# UNKNOWN, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 8731SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A REFILL ON (B)(6) 2012 IN WHICH A BRIDGE BOLUS WAS PROGRAMMED WITH A DURATION NOTED AT 14 HOURS AND 45 MINUTES PER THE PRINT OUT. THE PATIENT TRIED TO USE THE PERSONAL THERAPY MANAGER (PTM) TO GIVE HERSELF A BOLUS AFTER THE EXPECTED LOCK-OUT TIME, BUT RECEIVED AN ¿8503 PHYSICIAN BOLUS IN PROGRESS¿ ERROR MESSAGE. THE PATIENT WAS EXPERIENCING PAIN. THE PUMP WAS INTERROGATED THE DAY AFTER THE REFILL, BUT THE PRINT OUT INDICATED THAT 14 HOURS AND 45 MINUTES STILL REMAINED ON THE BRIDGE BOLUS. THE RESERVOIR VOLUME HAD DECREASED BY 0.3CC SINCE THE REFILL. AFTER VIEWING THE PRINT OUT IN MORE DETAIL, IT WAS DETERMINED THAT A BRIDGE BOLUS WAS PROGRAMMED UNNECESSARILY AS THERE WAS NO CHANGE TO THE DRUG CONCENTRATIONS. IT WAS NOTED THAT ON THE PRINT OUT TAKEN FROM THE TIME OF THE REFILL THE RESERVOIR VOLUME WAS THE FULL 40 CC BUT IT WAS LAST UPDATED ON (B)(6) 2011. THE ESTIMATED REPLACEMENT INDICATOR ALSO DISPLAYED ¿??¿ INSTEAD OF THE APPROPRIATE VALUE OF 74 MONTHS. THE BRIDGE BOLUS WAS CANCELED AND THE PATIENT WAS SE NT HOME. IT WAS LATER REPORTED THAT PTM WAS WORKING AND ALL WAS OKAY. THE DRUGS IN THE PUMP WERE HYDROMORPHONE, CLONIDINE, AND BUPIVACAINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303476 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR