BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 1915506 · Received November 5, 2010

    Report

    Report Number
    3004209178-2010-08932
    Event Type
    Malfunction
    Date Received
    November 5, 2010
    Date of Event
    July 1, 2010
    Report Date
    October 14, 2010
    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
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS NOT ABLE TO GET BOLUSES WHEN SHE THOUGHT SHE SHOULD BE ABLE TO. AFTER A REVIEW OF TECHNICAL REPORT AND LOGS IT APPEARED THIS WAS AN UPLINK ISSUE WHERE THE PUMP WAS DELIVERING THE BOLUS, BUT THE PT MONITOR (PTM) SHOWED IT WAS DENIED DUE TO TELEMETRY BEING INTERRUPTED ON THE UPLINK BACK TO PTM. SEVERAL MOTOR STALLS LASTING LESS THAN AN HOUR AND MOTOR STALL RECOVERIES WERE NOTED ON LOGS ON (B)(6) 2010 AND (B)(6) 2010. THE PUMP ADMINISTERED MORPHINE AT A CONCENTRATION OF 50 MG/ML AND A DOSE OF 28.533 MG/DAY, BUPIVICAINE AT A CONCENTRATION OF 30 MG/ML AND A DOSE OF 17.12 MG/DAY AND KETAMINE AT A CONCENTRATION OF 0.2 MG/ML AND A DOSE OF 0.11413 MG/DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Female CATHETER: MODEL 8731SC, LOT# N108359015.| EXPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 8835, LOT# UNK.| IMPLANTED:| IMPLANTED:| CATHETER: MODEL 8731SC, LOT# N108359015| EXPLANTED:| PROGRAMMER: MODEL 8835, LOT# UNK| EXPLANTED: