BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3347657 · Received September 13, 2013

    Report

    Report Number
    3004209178-2013-16212
    Event Type
    Malfunction
    Date Received
    September 13, 2013
    Report Date
    August 19, 2013
    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
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8590-1, LOT# N210439, IMPLANTED: 2009 (B)(6); PRODUCT TYPE ACCESSORY PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: 2009 (B)(6); PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ACTUAL RESIDUAL VOLUME (ARV) WAS GREATER THAN EXPECTED RESIDUAL VOLUME (ERV). ARV WAS 7ML AND ERV WAS 5.7ML. IT WAS NOTED THAT IT WAS THE FIRST TIME FOR A VOLUME DISCREPANCY AND THE PATIENT WAS ASYMPTOMATIC. IT WAS NOTED THAT THEY REFILL HER ¿EARLY¿ BECAUSE, SHE WAS ¿DIFFICULT TO STICK.¿ THE DEVICE SYSTEM WAS USED TO INFUSE FENTANYL. ADDITIONAL INFORMATION RECEIVED THE SAME DAY REVEALED THAT THE PATIENT WANTED THE HEALTHCARE PROVIDER (HCP) TO CONFIRM THE VOLUME OF 7ML ASPIRATED WAS FROM THE RESERVOIR AND NOT FROM THE SWELLING/FLUID AROUND HER PUMP POCKET SITE. THE SWELLING/FLUID HAD BEEN ¿GOING ON FOR SOME TIME.¿ ON THE DAY OF THE REPORT IT APPEARED TO BE ¿BETTER¿ AND WAS ¿IMPROVING.¿ IT WAS NOTED THAT PREDNISONE WAS PRESCRIBED FOR THE PATIENT. IT WAS THEN NOTED THAT THERE WERE NO THERAPY OR PATIENT COMPLAINTS. THE DEVICE SYSTEM WAS USED TO INFUSE SUFENTANIL. ADDITIONAL INFORMATION RECEIVED THE SAME DAY REPORTED THAT DURING A REFILL 7ML WAS INSTILLED BUT THE HCP (HEALTHCARE PROVIDER) WAS UNABLE TO ASPIRATED ANYTHING BACK (ONLY DROPS) TO CONFIRM ACCESS. THE CLINICAL SUPERVISOR WAS CALLED AND SAID THAT THE NEEDLE WAS PROBABLY AGAINST THE METAL PREVENTING ASPIRATION. THE PATIENT FELT ¿FINE.¿ THE HCP WAS GOING TO FILL WITH A ¿COUPLE MORE MLS¿ AND ATTEMPT TO ASPIRATE AGAIN. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460809 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00046 YR