BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3781681 · Received April 30, 2014

    Report

    Report Number
    3004209178-2014-08321
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    April 8, 2014
    Report Date
    April 9, 2014
    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
    KY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8709SC, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HEALTHCARE PROVIDER (HCP) WANTED TO CANCEL BOLUS IN-PROGRESS AND PROGRAM PUMP TO MINIMUM RATE MODE. IT WAS NOTED THAT THE HCP UPDATED PUMP TO MINIMUM RATE MODE. IT WAS REPORTED THAT THE PATIENT WAS OVERSEDATED AND WAS ¿NOT NECESSARILY BECAUSE OF THE PUMP AS PATIENT IS ON OTHER MEDS IN CONJUNCTION WITH THE PUMP. IT WAS NOTED THAT THE HCP WANTED PUMP STOPPED SO THEY PROGRAMMED IT TO MINIMUM RATE. IT WAS REPORTED THAT THE DRUG WAS CHANGED THE DAY PRIOR BUT THEY DID NOT KNOW THE SPECIFIC DRUG INFO BEFORE IT WAS CHANGED. IT WAS NOTED THAT THE PUMP WAS USED TO INFUSE HYDROMORPHONE. IT WAS REPORTED THAT THE PATIENT CONCENTRATION WAS 50 MG/ML AND DOSE WAS 3.63 MG/DAY. IT WAS LATER REPORTED THAT THE EMERGENCY ROOM (ER) CALLED STATING THAT THE PATIENT WAS FOUND LETHARGIC. IT WAS NOTED THAT THE PATIENT WAS ADMITTED TO THE ER. IT WAS REPORTED THAT THE PUMP WAS REFILLED ON (B)(6) 2014, ¿THEY HAD MISSED HER ORIGINAL REFILL DATE.¿ IT WAS NOTED THAT THE HCP DID NOT ¿FILL¿ THAT THE LETHARGY WAS DUE TO THE PUMP REFILL. IT WAS REPORTED THAT IT MAY BE FROM OTHER MEDICAL PROBLEMS. IT WAS NOTED THAT THE MEDICATIONS WOULD NOT BE DELIVERED BEFORE WEDNESDAY EVENING. IT WAS REPORTED THAT THE DAILY DOSE WAS 3.8 MG/DAY. IT WAS NOTED THAT THE BRIDGE BOLUS CATHETER VOLUME WAS 0.316 ML AND BOLUS DURATION WAS 79 HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259845 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR Required Intervention