BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 1832277 · Received September 3, 2010

    Report

    Report Number
    3004209178-2010-06772
    Event Type
    Malfunction
    Date Received
    September 3, 2010
    Date of Event
    August 7, 2010
    Report Date
    August 9, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNC
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    AN AUDIBLE CRITICAL PUMP ALARM OCCURRED REGARDING A PUMP GOING INTO SHELF STATE. THE ALARM WAS CONFIRMED BY TELEMETRY. THE PATIENT EXPERIENCED WITHDRAWAL SYMPTOMS. THE PUMP STATUS SCREEN SHOWED THAT THE PUMP WAS SET TO MINIMUM RATE, HOWEVER, WHEN THEY WENT TO THE INFUSION SETUP SCREEN IT WAS SET TO SIMPLE CONTINUOUS, WITH THE DOSE PER DAY BLANK. A PHYSICIAN FOUND THAT THE ELECTIVE REPLACEMENT INDICATOR (ER) WAS AT "1", HOWEVER, A MANUFACTURER REPRESENTATIVE INTERROGATED THE PUMP AND FOUND THE ERI TO BE 69 MONTHS. THE PATIENT'S STATUS, IN ADDITION TO THE TYPE OF MEDICATION, CONCENTRATION, AND DAILY DOSE BEING ADMINISTERED VIA THE PUMP WAS NOT REPORTED. ADDITIONAL INFORMATION IS BEING REQUESTED, AND WILL BE PROVIDED IN A FOLLOW-UP REPORT AS IT BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNC 8637-20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR IMPLANTED:| CATHETER: MODEL 8709, LOT# J11770R08