BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2834163 · Received November 15, 2012

    Report

    Report Number
    3004209178-2012-10324
    Event Type
    Injury
    Date Received
    November 15, 2012
    Date of Event
    October 17, 2012
    Report Date
    October 19, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PROGRAMMER MODEL: 8840, SERIAL# UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT HAD AN "UNDERDOSE REACTION". IT WAS STATED THAT THE WRONG DRUG CONCENTRATION HAD BEEN PROGRAMMED; "WRONG INTERPRETATION/ MISTAKE OF THE COMMA/POINT PLACE, 1`000 / 1.000, ABOUT 1000 COMMA PLACES" ON THE PHYSICIAN PROGRAMMER. THE RESULTED WRONG DRUG CONCENTRATION IN THE PUMP CAUSED PATIENT TO HAVE THE UNDERDOSE SYMPTOMS. PATIENT WAS TREATED IN A HOSPITAL "ACCORDING TO EMERGENCY AND HAD FILLED THE PUMP WITH THE RIGHT DOSAGE". PATIENT OUTCOME WAS REPORTED AS FULLY RECOVERED WITH NO INJURY. THE DRUG INFUSED IN THIS SYSTEM WAS UNKNOWN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R