BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2920382 · Received January 17, 2013

    Report

    Report Number
    3004209178-2013-00713
    Event Type
    Malfunction
    Date Received
    January 17, 2013
    Report Date
    December 28, 2012
    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
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED A VOLUME DISCREPANCY OCCURRED. THE ACTUAL RESIDUAL VOLUME WAS NOTED TO BE LESS THAN ONE MILLILITER (ML) AND THE EXPECTED RESIDUAL VOLUME WAS 15.3 ML'S, AT THE PATIENT'S SECOND REFILL SINCE IMPLANT. AT THE PATIENT'S FIRST REFILL, IT WAS NOTED THE EXPECTED AND ACTUAL VOLUMES HAD MATCHED. AFTER DISCOVERING THE VOLUME DISCREPANCY, THE REPORTER INJECTED 10 ML'S OF SALINE AND THEN ASPIRATED THE 10 ML'S AND CONFIRMED THEY WERE IN THE RESERVOIR. THE REPORTER INDICATED THE PATIENT'S HEALTH CARE PROVIDER WAS CONCERNED THAT THE PATIENT POSSIBLY COULD HAVE ACCESSED HER PUMP, BUT THIS WAS NOT CONFIRMED. THE REPORTER NOTED THE PATIENT WAS ALSO ON ORAL DILAUDID. THE PLAN WAS TO HAVE THE PATIENT COME BACK IN A COUPLE WEEKS TO CHECK THE VOLUME AS WELL AS TO CONTINUE TO TITRATE THE PATIENT'S DILAUDID AND BUPIVACAINE IN THE DEVICE SYSTEM. IT WAS LATER REPORTED THAT AT THE PATIENT'S NEXT REFILL ANOTHER VOLUME DISCREPANCY WAS DISCOVERED. THE ACTUAL RESIDUAL VOLUME WAS 3.8 ML AND THE ESTIMATED RESIDUAL VOLUME HAD BEEN 37.5 ML'S. THE REPORTER NOTED THEY WERE CONFIDENT THEY DID NOT FILL THE DRUG INTO THE POCKET. THE REPORTER AGAIN NOTED THE POSSIBILITY OF THE PATIENT ACCESSING THEIR PUMP AND NOTED THE PATIENT WAS A NURSE. THE PATIENT WAS REPORTED TO HAVE BEEN WALKING, TALKING, AND WAS NOT HAVING ANY ISSUES. IT WAS REPORTED THE PATIENT STILL HAD A SCAB OVER THEIR PUMP SITE AND THAT IT HAD BEEN ALMOST TWO WEEKS SINCE THEY HAD LAST FILLED THE PUMP. THE REPORTER FILLED THE PATIENT'S PUMP WITH SALINE AT THE REFILL BECAUSE THEY WEREN'T SURE IF IT WAS SAFE TO KEEP FILLING IT WITH MEDICATION AND DECIDED TO BRING THE PATIENT BACK AT A LATER TIME TO CHECK THE RESERVOIR VOLUMES. THE PUMP WAS PROGRAMMED TO DELIVER SALINE WITHOUT A BRIDGE BOLUS AND NOTED THE PATIENT WOULD GET HALF OF THE PRESCRIBED DOSE OF DILAUDID AND BUPIVACAINE FOR BETWEEN 4.5 DAYS AND 5.7 DAYS. THE PATIENT WAS ALSO GIVEN ORAL MEDICATIONS TO COVER HER. ADDITIONAL INFORMATION RECEIVED REPORTED THE CAUSE OF THE EVENT WAS UNKNOWN. IT WAS NOTED THIS WAS A NEW PUMP, WHICH HAD BEEN REFILLED ONCE BEFORE AT WHICH TIME THE RESIDUAL WAS "EXACTLY RIGHT". THE REPORTER INDICATED THEY STILL SUSPECTED THE PATIENT WAS TAMPERING. IT WAS NOTED THE PATIENT EXPERIENCED NO SIGNS OR SYMPTOMS RELATED TO THE ASSOCIATED EVENT AND EXPERIENCED NO INJURY. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26683 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1