BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3803139 · Received May 9, 2014

    Report

    Report Number
    3004209178-2014-08826
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Date of Event
    April 16, 2014
    Report Date
    April 16, 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
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2003, PRODUCT TYPE: CATHETER. (B)(4). EVALUATION SUMMARY: THE PUMP CONNECTOR WAS RETURNED FOR ANALYSIS. ANALYSIS FOUND ¿CORING-TEARS-CUTS IN SEAL DUE TO OUTLET PORT ¿ NOT USER RELATED¿.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS IN SURGERY FOR NORMAL ERI (ELECTIVE REPLACEMENT INDICATOR). DURING THE REPLACEMENT, THE PHYSICIAN STATED THAT THERE WAS A LOT OF CRYSTALLIZATION IN THE PUMP POCKET. THE CRYSTALLIZATION WAS FOUND IN THE PUMP POCKET AND IN THE PUMP CONNECTOR. HE STATED IT WAS POSSIBLE THAT THE PUMP CONNECTOR WAS NOT ATTACHED PROPERLY TO PUMP. THE PUMP CONNECTOR WAS REPLACED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT. THE PATIENT STATUS WAS REPORTED AS ¿ALIVE ¿ NO INJURY¿. THE DEVICE SYSTEM WAS DELIVERING HYDROMORPHONE AND BUPIVACAINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281382 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 00057 YR