BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2900459 · Received January 7, 2013

    Report

    Report Number
    3004209178-2013-00276
    Event Type
    Malfunction
    Date Received
    January 7, 2013
    Report Date
    December 13, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8840, SERIAL # UNKNOWN, PRODUCT TYPE: PHYSICIAN, PROGRAMMER-HANDHELD,DDB.

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: 2006-(B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE CAUSE OF THE EVENT WAS SCUBA DIVING. IT WAS ALSO NOTED THAT A FLUOROSCOPY EXAMINATION, ON (B)(6), WAS NORMAL. THE PATIENT OUTCOME WAS NOTATED AS "NO INJURY". SIXTEEN DAYS LATER, IT WAS REPORTED THAT IT WAS UNKNOWN WHETHER THE PUMP WOULD BE REPLACED, THOUGH IT WAS "MALFUNCTIONING".

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE ACTUAL RESIDUAL VOLUME IN THE PUMP WAS 0.5 MILLILITERS (ML) AND THE EXPECTED RESIDUAL VOLUME WAS 3.4 ML. THE PUMP LOGS WERE CHECKED AND SHOWED NO ISSUES. DURING THE PREVIOUSLY REPORTED THE (B)(6) 2012 REFILL, THE PUMP WAS ONLY ABLE TO BE FILLED WITH 14 ML AFTER THE PATIENT WENT SCUBA DIVING IN (B)(6) 2012. X-RAYS WERE TAKEN AND SHOWED NO VISIBLE DAMAGE TO THE PUMP, WITH THE PUMP LOOKING "PERFECTLY FLAT". OTHER THAN THE VOLUME DISCREPANCY, THE PUMP APPEARED TO BE WORKING. AT THE REFILL ON THE DATE OF THIS REPORT, THE PUMP WAS ABLE TO BE FILLED TO CAPACITY AT 20 ML. TO ENSURE THE MEDICATION WAS NOT IN THE POCKET, THE FULL 20 ML WAS WITHDRAWN AND PUT BACK IN SUCCESSFULLY. SIX DAYS LATER IT WAS REPORTED THE CAUSE OF THE VOLUME DISCREPANCY WAS A MISTAKE IN PROGRAMMING DURING THE DECEMBER REFILL WHEN ONLY 14 ML WERE FILLED. AFTER "DOING THE ARITHMETIC" IT WAS DETERMINED THE RESIDUAL VOLUME WAS "SPOT ON".

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS DIFFICULTY FILLING THE RESERVOIR. THE HEALTH CARE PROVIDER (HCP) WAS NOT ABLE TO PUSH IN THE LAST 5 CC'S OF THE 20 CC VOLUME. A FRESH SYRINGE WAS PUT ON THE FILL TUBING AND THE HCP WAS ABLE TO WITHDRAW THE FULL QUANTITY THAT WAS PUT INTO THE RESERVOIR. WHEN THE HCP PUT THE SYRINGE BACK ON, IT STILL DID NOT ACCEPT THE LAST 5 CC'S. THE PHYSICIAN HAD ATTEMPTED HOLDING BACK NEGATIVE PRESSURE ON THE SYRINGE TO RULE OUT THE POSSIBILITY OF AIR BEING IN THE RESERVOIR, AND WAS GOING TO ATTEMPT DOING SO AGAIN. IT WAS REPORTED THE PATIENT HAD DOVE 80 FEET SCUBA DIVING AROUND THANKSGIVING. THE REPORTER INDICATED FURTHER TROUBLESHOOTING WAS BEING CONTEMPLATED. THE DEVICE SYSTEM WAS USED TO DELIVER HYDROMORPHONE. 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
    7163 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1