BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3872532 · Received June 13, 2014

    Report

    Report Number
    3004209178-2014-11571
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Report Date
    May 23, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMTIANT PRODUCT: PRODUCT ID 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS DUE FOR A REFILL, BUT IT WAS UNKNOWN WHEN THE PATIENT WAS DUE AND THE PATIENT WAS DISCHARGED TO THEIR NURSING HOME FACILITY. THE HEALTHCARE PROVIDER (HCP) WAS UNFAMILIAR WITH THE PUMP AND HAD NO HISTORY. IT WAS ALSO REPORTED ACCORDING TO THE PATIENT¿S FAMILY, THE PUMP WAS EMPTY, BUT THEY HAD NOT HEARD IT ALARM. IT WAS NOTED THE PATIENT USED TO BE FILLED AT HIS HOME. IT WAS UNKNOWN WHAT DRUG THE PUMP WAS BEING USED TO DELIVER. ADDITIONAL INFORMATION HAS BEEN REQUESTED; A FOLLOW-UP REPORT WILL BE SENT WHEN IT BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351099 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1