BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3539807 · Received December 27, 2013

    Report

    Report Number
    3004209178-2013-24071
    Event Type
    Malfunction
    Date Received
    December 27, 2013
    Date of Event
    December 10, 2013
    Report Date
    December 10, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8575, LOT# N152945, IMPLANTED: 2008 (B)(6); PRODUCT TYPE ACCESSORY PRODUCT ID 8709 LOT# J10952R30, IMPLANTED: 2001 (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 AN ERROR WAS MADE WHEN PROGRAMMING THE PUMP EARLIER ON THE DATE OF THIS REPORT. THERE WAS 40 MILLIGRAMS (MG) PER MILLILITER (ML) IN THE PUMP AND THAT WAS SWITCHED TO 25 MG/ML BUT THE PHYSICIAN PROGRAMMER WAS NOT UPDATED TO REFLECT THE CHANGE. THE PUMP HAD BEEN RUNNING APPROXIMATELY 90 MINUTES WITH A BRIDGE BOLUS PROGRAMMED WITH A DURATION OF 51 HOURS AND 46 MINUTES. THE BRIDGE BOLUS WAS NOW CANCELLED AND A MODIFIED BRIDGE BOLUS USING THE PRIMING BOLUS FUNCTION WAS PROGRAMMED WHICH RESOLVED THE ISSUE. REPORTEDLY, THERE WAS NO THERAPY OR MEDICAL PROBLEM. THIS DEVICE SYSTEM DELIVERED MORPHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    677455 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR