BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3120784 · Received May 20, 2013

    Report

    Report Number
    3004209178-2013-07931
    Event Type
    Malfunction
    Date Received
    May 20, 2013
    Report Date
    April 22, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8840 LOT# SERIAL# UNKNOWN, PRODUCT TYPE PROGRAMMER, PHYSICIAN PRODUCT ID 8709SC LOT# SERIAL# (B)(4), IMPLANTED: 2009 (B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THE HCP CANNOT ESTABLISH TELEMETRY WITH THE PUMP. HCP TRIED NUMEROUS TIMES GOING ALL AROUND THE OUTSIDE OF THE PUMP. HCP HAD INTERROGATED TWO TO THREE OTHER PUMPS WITH THE SAME PROGRAMMER IN THE SAME ROOM WITH NO ISSUES BUT CANNOT ESTABLISH TELEMETRY WITH THE PUMP. THE HCP HEARD ONE BEEP AND THEN THE TELEMETRY QUITS. HCP NOTED THAT THE PATIENT WAS SKINNY. THE PUMP WAS DELIVERING LIORESAL.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THE CAUSE OF THE EVENT WAS INTERFERENCE WITH THE COMPUTER EQUIPMENT IN THE BUILDING. THERE WAS ELECTRONIC INTERFERENCE WITH THE DATA PROCESSING ROOM NEXT TO THE PROCEDURE ROOM. IT WAS A BRAND NEW CLINIC. THE PROCEDURE ROOM WAS NEXT TO THE SERVER ROOM. THE PROGRAMMER WOULD NOT FUNCTION. THEY MOVED TO ANOTHER ROOM AND THERE WAS NO PROBLEM. THE PATIENT OUTCOME WAS NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222710 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1