BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 4274418 · Received November 24, 2014

    Report

    Report Number
    3004209178-2014-22121
    Event Type
    Malfunction
    Date Received
    November 24, 2014
    Report Date
    November 3, 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
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8731,SERIAL# (B)(4), IMPLANTED: (B)(6) 2004, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A VOLUME DISCREPANCY WHERE THE EXPECTED VOLUME WAS 5 ML BUT THE ACTUAL VOLUME WAS 20 ML. THE CAUSE OF THE DISCREPANCY WAS UNKNOWN; THE PATIENT WAS SENT OUT WITH AN ORDER FOR X-RAYS AND FOLLOW UP WOULD BE DONE AFTERWARDS. THE PATIENT WAS ADMINISTERED MEDICINE ¿PRN¿ (PRO RE NATA/AS NEEDED) AND TOOK ORAL MEDICATIONS AS WELL. THE PATIENT WAS ALIVE WITH NO INJURY BUT IT WAS NOTED THAT THE PATIENT WAS IN PAIN (4 ON A SCALE 0-10). THE PUMP WAS USED TO INFUSE MORPHINE. NO INTERVENTIONS OR OUTCOMES WERE REPORTED, THOUGH IT WAS STATED THAT THE FILE WOULD BE UPDATED IT A DYE STUDY WAS PLANNED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    759592 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00057 YR