BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2230768 · Received August 23, 2011

    Report

    Report Number
    3004209178-2011-06745
    Event Type
    Injury
    Date Received
    August 23, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 1, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT A PRIMING BOLUS WAS INCORRECTLY PERFORMED DURING A PUMP REPLACEMENT PROCEDURE. AFTER PROGRAMMING THE BOLUS, THE DURATION THAT WAS PROGRAMMED HAD ELAPSED, AND THE PUMP WAS HANDED OFF AND IMPLANTED. THE STATUS OF THE PUMP WAS CHECKED, AND IT WAS NOTICED THAT THE PRIMING BOLUS HAD NOT COMPLETED. IT WAS DETERMINED THAT INSTEAD OF A 19 MINUTE PRIMING BOLUS, A 19 HOUR BOLUS DURATION WAS PROGRAMMED INSTEAD. THE BOLUS WAS CANCELED; AND 1 HOUR AND 6 MINUTES ELAPSED AND 0.018 ML WAS DELIVERED. IT WAS FURTHER REPORTED THAT THE PUMP WAS RUNNING FOR 8 HOURS AT 12 MCG/HR, AND 5 HOURS AT 14.5 MCHG/HR. A BOLUS WAS PROGRAMMED FOR 1 HOUR AND 10 MINUTES; DELIVERING 0.017 ML. THE PHYSICIAN BELIEVED THE CATHETER WAS EMPTY SINCE HE SAW IT DRIP 5 ML DURING THE PROCEDURE. THE DRUG INFUSED WAS LIORESAL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other PROGRAMMER: MODEL 8840, LOT# UNKNOWN| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8578, LOT# N292042004