BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2964358 · Received February 15, 2013

    Report

    Report Number
    3004209178-2013-02731
    Event Type
    Injury
    Date Received
    February 15, 2013
    Report Date
    January 21, 2013
    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
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: CATHETER: MODEL: 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2003, EXPLANTED: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THAT THE HEALTH CARE PROFESSIONAL (HCP) REPLACED THE PUMP AND CATHETER. IT WAS NOTED THAT THE REASON FOR PUMP REMOVAL WAS THAT IT WAS AGING. THE HCP HAD HAD CONCERNS REGARDING THE CATHETER. THE PATIENT WAS HOSPITALIZED AND HIS OUTCOME WAS NOTED AS 'NO INJURY.' THE DRUGS IN THE PUMP WERE MORPHINE AND CLONIDINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A VOLUME DISCREPANCY OCCURRED ON A PUMP. THE ESTIMATED VOLUME REMAINING WAS 2.4ML BUT FOUND 10ML WERE LEFT. THE VOLUME DISCREPANCY HAS OCCURRED OVER THE "LAST FEW" REFILLS. IT WAS ANTICIPATED THAT "4-6 ML" MORE ARE BEING DRAWN OFF AT REFILL. A CATHETER DYE STUDY WAS ATTEMPTED BUT THE PHYSICIAN WAS UNABLE TO DRAW BACK FLUID OUT OF THE CATHETER ACCESS PORT. IT WAS LATER REPORTED THAT THE CATHETER WAS REPLACED ON (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68167 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR Hospitalization| R