BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3903382 · Received June 30, 2014

    Report

    Report Number
    3004209178-2014-12308
    Event Type
    Injury
    Date Received
    June 30, 2014
    Report Date
    June 9, 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
    NH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE EVENT WAS DESCRIBED AS THE PUMP LEAKED OUT ALL OF THE FENTANYL INTO THE PATIENT. THEY WERE NOT SURE IF IT WAS THE DEVICE OR THE PERSON FILLING IT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED AN OVERDOSE AND THE PATIENT HAD TWO EPISODES AT REFILLS WHERE SHE GOT RIGID, FEET TURNED IN, AND OXYGEN SATURATION DECREASES HAPPENED FIVE MINUTES POST REFILL. IT WAS NOTED THE PATIENT¿S FIRST EPISODE WAS (B)(6) 2013 AND THIS OCCURRED AGAIN IN (B)(6) 2014. IT WAS FURTHER REPORTED WITH THE FIRST EPISODE SYMPTOMS THE PATIENT WENT HOME AND THE SECOND EPISODE THE PATIENT WAS SEEN THE EMERGENCY ROOM/HOSPITAL, WAS DIAGNOSED WITH OVERDOSE AND GIVEN NARCAN. THE PATIENT RESPONDED POSITIVELY TO THE NARCAN. IT WAS NOTED THERE HAD BEEN NO VOLUME DISCREPANCIES AT THE (B)(6) 2013 REFILL AND THE EXPECTED RESIDUAL VOLUME (ERV) WAS 14.6 ML AND THE ACTUAL RESIDUAL VOLUME (ARV) WAS 15 ML. AT THE (B)(6) 2014 REFILL THE ERV WAS 3.6ML AND THE ARV WAS 2.5 ML. IT WAS ALSO REPORTED THE PUMP HAD BEEN INFUSING AT MINIMUM RATE MODE SINCE THE (B)(6) 2014 INCIDENT. THE PATIENT¿S HUSBAND MENTIONED THAT THE PATIENT HAD A SIMILAR EPISODE WHILE IN MINIMUM RATE MODE (LASTED ALL DAY) SINCE (B)(6) 2014 REFILL. IT WAS REPORTED THE HEALTHCARE PROVIDER (HCP) WAS QUESTIONING SEIZURE LIKE ACTIVITY AND THE PATIENT WAS HARD TO MOVE WHEN SHE HAD THESE EPISODES. THE PUMP WAS BEING USED TO DELIVER FENTANYL. ADDITIONAL INFORMATION HAS BEEN REQUESTED; A FOLLOW-UP REPORT WILL BE SENT WHEN IT BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379594 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR Required Intervention