BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2931847 · Received January 28, 2013

    Report

    Report Number
    3004209178-2013-01055
    Event Type
    Malfunction
    Date Received
    January 28, 2013
    Report Date
    January 4, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8840, SERIAL# UNKNOWN, PRODUCT TYPE PROGRAMMER, PHYSICIAN; PRODUCT ID 8835, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    A DATA ENTRY ERROR WAS REPORTED. WHEN PERFORMING A BRIDGE BOLUS, THE PATIENT'S HEALTHCARE PROVIDER INDICATED THAT THEY HAD MISTAKENLY ENTERED THE DRUG CONCENTRATION VALUE (UG/ML) RATHER THAN THE 'OLD DRUG DESIRED DOSE' (UL/DAY). THE BOLUS DURATION WAS FOUND TO BE 231 HOURS, AND THE ISSUE WAS NOTED TO BE RESOLVED. THE MEDICATIONS USED WITHIN THE SYSTEM WERE DILAUDID, BUPIVACAINE, AND CLONIDINE. NO ADDITIONAL INFORMATION WAS AVAILABLE AT THE TIME OF THIS SUBMISSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37929 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1