BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3202699 · Received July 2, 2013

    Report

    Report Number
    3004209178-2013-04581
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    May 17, 2012
    Report Date
    May 17, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8731 SERIAL# (B)(4), IMPLANTED: 2005 (B)(6), PRODUCT TYPE CATHETER PRODUCT ID: 8840 SERIAL# UNKNOWN, PRODUCT TYPE PROGRAMMER, PHYSICIAN (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP WAS PRIMED ON THE BACK TABLE. THE PRIMING BOLUS WAS PROGRAMMED FOR 19 HOURS INSTEAD OF 19 MINUTES. THE PRIME WAS RUN FOR 20 MINUTES AND THE PUMP WAS CONNECTED TO THE CATHETER AND IMPLANTED. THE PRIME RAN FOR 47 MINUTES UNTIL THE MISTAKE WAS NOTICED AND IT WAS STOPPED. THE HEALTHCARE PROVIDER (HCP) OPENED THE PATIENT AND REMOVED THE PUMP. THE PUMP WAS PRIMED WITH 0.3 ML OVER 20 MINUTES AND THEN RE-IMPLANTED. THE PATIENT HAD NO ADVERSE EFFECTS AND WAS DOING ¿WELL.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300973 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00052 YR Required Intervention