BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3757671 · Received April 17, 2014

    Report

    Report Number
    3004209178-2014-07467
    Event Type
    Malfunction
    Date Received
    April 17, 2014
    Date of Event
    March 28, 2014
    Report Date
    March 29, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: 2008 (B)(6); PRODUCT TYPE CATHETER PRODUCT ID 85 90-1, LOT# N152935, IMPLANTED: 2008 (B)(6); PRODUCT TYPE ACCESSORY PRODUCT ID NEU_UNKNOWN_PROG; PRODUCT TYPE PROGRAMMER, PHYSICIAN PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: 2008 (B)(6); PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ALARM WAS HEARD AND TELEMETRY HAD NOT YET BEEN PERFORMED. FOLLOWING PUMP IMPLANT, THE PUMP WAS PROGRAMMED TO MINIMUM RATE. THE PUMP WAS ALARMING OVERNIGHT. THE PHYSICIAN SPENT AN HOUR WITH THE PATIENT ON THE REPORT DATE AND DID NOT HEAR THE ALARM. THE PATIENT HEARD A ¿BEEP¿. THE PATIENT WAS NOT HAVING ANY SYMPTOMS. IT WAS NOTED THAT THE PUMP WAS FILLED WITH A 2MG/ML CONCENTRATION BECAUSE THAT WAS WHAT WAS AVAILABLE. HOWEVER, THE CATHETER HAD A 20MG/ML CONCENTRATION BECAUSE IT WAS UNABLE TO BE ASPIRATED. THE PUMP WAS NOT PRIMED ON THE BACK TABLE. THE PUMP WAS PROGRAMMED TO 2MG/ML AND WAS CURRENTLY RUNNING AT 0.1MG/DAY. IT WAS CALCULATED THAT IT WOULD TAKE 4 DAYS TO DELIVER THE MEDICATION IN THE CATHETER AT THE CURRENT RATE AND THE PATIENT WOULD GET A MINIMUM OF A 4 DAY GAP DUE TO NOT PRIMING THE PUMP TUBING. THE DEVICE SYSTEM WAS USED TO DELIVER MORPHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234826 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00052 YR