BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3072483 · Received April 23, 2013

    Report

    Report Number
    3004209178-2013-06727
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Report Date
    March 27, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013. PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE AFTER THE SALINE WAS WITHDRAWN FROM THE PUMP, ONLY 14CC OF MORPHINE SULFATE COULD BE INJECTED. THE REPORTER STATED THAT THERE WAS PROBABLY AIR IN THE PUMP. NOTHING COULD BE INJECTED OR WITHDRAWN AS THE PUMP HAD LOCKED. IT WAS NOTED THAT THE PUMP WAS BRAND-NEW AND HAD NOT YET BEEN IMPLANTED AT THE TIME OF REPORT. TWO DAYS LATER, IT WAS REPORTED THAT THE PATIENT WAS DOING "FINE" AND WAS RECEIVING EFFECTIVE THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175141 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637

    Patients

    Seq Age Sex Outcome Treatment
    1