BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 5054429 · Received September 3, 2015

    Report

    Report Number
    3004209178-2015-17287
    Event Type
    Malfunction
    Date Received
    September 3, 2015
    Date of Event
    August 11, 2015
    Report Date
    August 11, 2015
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8731SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: CATHETER. PRODUCT ID: 8840, PRODUCT TYPE: PROGRAMMER, PHYSICIAN. (B)(4)

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURER'S REPRESENTATIVE (MR) REGARDING A PATIENT RECEIVING HYDROMORPHONE (15.0 MG/ML AT 1.316 MG/DAY) VIA AN IMPLANTED PUMP IN SIMPLE CONTINUOUS INFUSION MODE. THE HCP INTERROGATED THE PUMP AND GOT A PUMP MEMORY ERROR (PME) MESSAGE AND IT WOULDN'T LET THEM CHANGE ANY SETTINGS OR DO ANYTHING WITH THE PUMP. THE HCP TRIED WITH 3 DIFFERENT PROGRAMMERS AND GOT THE SAME PME MESSAGE. THE MR DIDN'T KNOW WHETHER THE PUMP WAS ALARMING. THE PATIENT WAS REPORTEDLY IN HIS ROOM IN THE HOSPITAL AND THEY WERE TRYING TO DO A REFILL. THE MR LATER REPORTED THAT THE ISSUE WAS RESOLVED BY ENTERING THE ALARM VOLUME. NO CAUSE OF EVENT OR SYMPTOMS WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED; A FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585556 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR