BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 4809787 · Received June 1, 2015

    Report

    Report Number
    3004209178-2015-10067
    Event Type
    Malfunction
    Date Received
    June 1, 2015
    Date of Event
    May 9, 2015
    Report Date
    May 11, 2015
    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
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ALARM WAS HEARD AND CONFIRMED BY TELEMETRY. THE CRITICAL ALARM WAS A SAFE STATE ALARM AND THE LOGS REVEAL THE SAFE STATE OCCURRED ON (B)(6) 2015 AT 15:39. THE PUMP WAS REPROGRAMMED BACK TO SIMPLE CONTINUOUS MODE. THE PATIENT HEARD THE ALARM AT HOME AND FELT ¿PINS AND NEEDLES.¿ IT WAS UNKNOWN IF A PUMP RESET MESSAGE OCCURRED PRIOR TO THE SAFE RATE. THE SAFE RATE DID NOT OCCUR WHILE UPDATING THE PUMP OR WHILE A FLEX BOLUS WAS IN USE. IT WAS UNKNOWN IF ELECTROMAGNETIC INTERFERENCE OR AN MRI WAS ASSOCIATED WITH THE SAFE RATE. THE PATIENT RECOVERED WITHOUT PERMANENT IMPAIRMENT. THE TYPE OF MEDICATION BEING DELIVERED VIA THE DEVICE SYSTEM WAS LIORESAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352580 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR