BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2251125 · Received September 8, 2011

    Report

    Report Number
    3004209178-2011-07607
    Event Type
    Malfunction
    Date Received
    September 8, 2011
    Date of Event
    September 2, 2011
    Report Date
    September 2, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BRIDGE BOLUS WAS INCORRECTLY PERFORMED. OLD DRUG DESIRED DOSE WAS NOT ACCURATELY SELECTED. DRUGS DELIVERED VIA THE SYSTEM WERE HYDROMORPHONE AND FENTANYL. OLD DRUG/CONCENTRATION: 1MG; OLD DRUG DESIRED DOSE: .56 MG/DAY; OLD FLOW RATE: .56 MLS/DAY; NEW DRUG/CONCENTRATION: 2000 MCG; DAILY DOSE NEW DRUG: 999.1 MG/DAY; NEW FLOW RATE: .4996 MLS/DAY; TDV: .3018 MSL; AMOUNT OF BOLUS: 603.6 MCG; DURATION OF BOLUS: 12 HRS 56 MINS. A FOLLOW-UP REPORT WILL BE SENT IF MORE INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 8637-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR CATHETER: MODEL 8709, LOT# N230102004| PROGRAMMER: MODEL 8840, LOT# UNKNOWN| IMPLANTED:| EXPLANTED: