BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3162231 · Received June 11, 2013

    Report

    Report Number
    3004209178-2013-10134
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    February 2, 2013
    Report Date
    May 14, 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
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8709, SERIAL # (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE CATHETER; PRODUCT ID NEU_UNKNOWN_PROG, PRODUCT TYPE PROGRAMMER, PHYSICIAN; PRODUCT ID 8709, SERIAL # (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS PUMP HAD ALARMED AND WAS CONFIRMED BY TELEMETRY FROM THE EMPTY RESERVOIR WHICH HAD OCCURRED ON (B)(6) 2013. THIS HAD OCCURRED WHILE THE PATIENT WAS IN A LONG-TERM CARE FACILITY. ASPIRATION THROUGH THE CATHETER ACCESS PORT (CAP) WAS UNSUCCESSFUL AS THERE WAS NO CEREBRAL SPINAL FLUID BACKFLOW. THE PATIENT REPORTEDLY HAD ¿MANY OTHER¿ CO-MORBIDITIES THAT MAY LIMIT HIM FROM HAVING THE PUMP REPLACED. AS A RESULT, THE PHYSICIAN WANTED THE PUMP TO BE PROGRAMMED OFF PERMANENTLY RATHER THAN PUTTING SALINE IN THE PUMP AND RUNNING AT MINIMUM RATE. HOWEVER, THE HEALTH CARE PROVIDER (HCP) HAD TRIED TO DISABLE THE PUMP AND ENCOUNTERED AN ERROR. THIS HAD OCCURRED AS THE HCP ATTEMPTED TO PROGRAM THE PUMP WITH A PREVIOUS CODE. THIS DEVICE SYSTEM DELIVERED BUPIVACAINE AND MORPHINE. IT WAS ALSO REPORTED THAT THE HCP DID TRY TO GET A HOLD OF THE PATIENT AS THE PATIENT MISSED AN APPOINTMENT DUE TO A CAR ACCIDENT AND HE HAD SINCE BEEN IN A NURSING FACILITY. THE ¿SIDE PORT CATHETER¿ WAS ATTEMPTED AND REPORTEDLY WAS NOT PATENT AS NEITHER MEDICATION NOR CEREBRAL SPINAL FLUID WAS ASPIRATED. THE PATIENT REPORTEDLY STATED HE JUST ¿DIDN¿T FEEL GOOD¿ AS A RESULT OF THE EMPTY PUMP ALTHOUGH THE HCP STATED THAT THE PATIENT HAD A ¿FILL PUMP.¿ REPORTEDLY, THE PATIENT ¿GOT SO MANY OTHER COMA¿ THAT A SURGICAL REVISION WAS LIKELY NOT AN OPTION AT THIS TIME. THE APPROPRIATE PUMP DISABLE CODE WAS PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION LATER RECEIVED FROM THE HCP INDICATED THE SYMPTOMS THE PATIENT EXPERIENCED WERE REPORTEDLY WITHDRAWAL SYMPTOMS. IT WAS ALSO NOTED THAT DUE TO COMORBIDITIES NORMAL SALINE WAS PLACED IN THE PATIENT¿S PUMP (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262053 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR