BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3873842 · Received June 16, 2014

    Report

    Report Number
    3004209178-2014-11600
    Event Type
    Malfunction
    Date Received
    June 16, 2014
    Date of Event
    December 1, 2011
    Report Date
    June 13, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE CATHETER; PRODUCT ID 8590-9, LOT# N260038, IMPLANTED: (B)(6) 2011, PRODUCT TYPE ACCESSORY; PRODUCT ID NEU_UNKNOWN_CATH, SERIAL# UNKNOWN, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE ARV WAS GREATER THAN THE ERV. IN DECEMBER THE ARV 6ML AND ERV 3.9ML. ON (B)(6) ARV 9ML AND ERV 5ML. IT WAS NOTED THE PUMP WAS A 40ML PUMP. THE PATIENT WAS NOT SYMPTOMATIC. THE PUMP WAS USED TO DELIVER DILAUDID AND MARCAINE. ADDITIONAL INFORMATION LATER REPORTED THE DEVICE WAS RETURNED FOR DISPOSAL ONLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353073 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR