BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNCHROMED II

    MDR report key: 2023609 · Received December 21, 2010

    Report

    Report Number
    3004209178-2010-10636
    Event Type
    Other
    Date Received
    December 21, 2010
    Date of Event
    December 1, 2010
    Report Date
    December 6, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PRIMING BOLUS WAS PERFORMED INCORRECTLY. THE INCORRECT VOLUME WAS CONVERTED INTO A SINGLE BOLUS OF HYDROMORPHONE 5 MG/ML FOR A TOTAL OF A 2.32 MG BOLUS. THE PUMP SHOULD HAVE BEEN PROGRAMMED TO DELIVER 0.199 + 0.176 ML EQUALLING 0.375 ML OF 5 MG/ML EQUALLING A 1.875 MG BOLUS. THE PATIENT WOULD RECEIVE APPROXIMATELY A 0.45 MG BOLUS WHICH WAS ALMOST EQUIVALENT TO THE PATIENT'S DAILY DOSE. THE HCP WAS CHANGING FROM THE OLD DRUG, SALINE TO NEW DRUG, HYDROMORPHONE. NO PATIENT SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR IMPLANTED:| CATHETER: MODEL 8709C, LOT# N262595007| PROGRAMMER: MODEL 8840, LOT# UNKNOWN| EXPLANTED: