BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4150147 · Received October 7, 2014

    Report

    Report Number
    3004209178-2014-18469
    Event Type
    Injury
    Date Received
    October 7, 2014
    Date of Event
    September 10, 2014
    Report Date
    January 18, 2017
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-1570-2014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DESTRUCTIVE ANALYSIS OF THE PUMP WAS COMPLETED AND NO ADDITIONAL ANOMALIES WERE FOUND.

    Additional Manufacturer Narrative · 1

    CONCOMITANT: PRODUCT ID 8598A, SERIAL# (B)(4), IMPLANTED: 2010-(B)(6), PRODUCT TYPE CATHETER. PRODUCT ID 8711, SERIAL# (B)(4), IMPLANTED: 2010-(B)(6), PRODUCT TYPE CATHETER. (B)(4). ANALYSIS OF THE PUMP FOUND THERE WAS OVERINFUSION WITH AN UNDETERMINED ROOT CAUSE.

    Description of Event or Problem · 1

    (B)(4) 2014 (REP): ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PUMP SYSTEM WAS DELIVERING MORPHINE AND BUPIVACAINE.

    Description of Event or Problem · 1

    THE PUMP WAS REFILLED ON 2014-(B)(6) AND AT THAT TIME A VOLUME DISCREPANCY WAS NOTED. THE EXPECTED VOLUME RESERVOIR (ERV) WAS 8ML THE ACTUAL RESIDUAL VOLUME (ARV) WAS 1ML. THE PHYSICIAN WAS CONCERNED BECAUSE IT HAD ALWAYS BEEN VERY PREDICABLE AND ACCURATE RESIDUAL VOLUME COMPARED TO WHAT WAS EXPECTED. THIS HAD BEEN THE 2ND REFILL IN A ROW WHERE A LARGER VOLUME DISCREPANCY WAS NOTED AND OVER INFUSION WAS SUSPECTED. PATIENT HAD SYMPTOMS OF ALTERED MENTAL STATUS (AMS). THE PATIENT'S AMS WAS NOT CONFIRMED TO BE ASSOCIATED WITH PUMP BUT THE CLINICIAN SUSPECTED IT MAY BE CONNECTED IF PUMP WAS INDEED OVER INFUSING. IT WAS REPORTED THAT THERE WAS SURGICAL REPLACEMENT FOR THE PUMP SCHEDULED FOR 2014-(B)(6). THE PATIENT'S STATUS AT THE TIME OF DELIVERY WAS "ALIVE-NO INJURY." THE PUMP WAS INFUSING MORPHINE. (NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    627319 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR Required Intervention