BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3204420 · Received July 3, 2013

    Report

    Report Number
    3004209178-2013-06004
    Event Type
    Malfunction
    Date Received
    July 3, 2013
    Date of Event
    January 25, 2012
    Report Date
    April 11, 2013
    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
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8578, SERIAL# (B)(4), IMPLANTED: 2010 (B)(6); PRODUCT TYPE ACCESSORY PRODUCT ID 8709 LOT# L55001, IMPLANTED: 1998 (B)(6); PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT A REFILL, THE HEALTHCARE PROVIDER (HCP) ASPIRATED OUT AN AMBER FLUID FROM THE RESERVOIR FILL PORT ((B)(6) 2012). IT WAS STATED THAT THE DILAUDID WAS IN THE PUMP FOR 91 DAYS. THE HCP CONFIRMED THAT THE NEEDLE WAS IN THE RESERVOIR FILL PORT. PER HCP, THE REFILL WAS UNEVENTFUL AND PATIENT WAS ASYMPTOMATIC WITH NO SIGNS OR SYMPTOMS OF INFECTION. THE HCP WAS TO SEND THE AMBER FLUID FOR ANALYSIS. DRUG: DILAUDID (HYDROMORPHONE; 5 MG/ML, 1.04 MG/DAY).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303760 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR