BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 4122562 · Received September 26, 2014

    Report

    Report Number
    3004209178-2014-17816
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Report Date
    September 3, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-1060-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: UNKNOWN CATH, SERIAL# UNKNOWN, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE PATIENT UNDERWENT A DYE STUDY. EVERYTHING WAS NORMAL AT THAT TIME. FLUOROSCOPY WAS USED AND THE PUMP WAS ACCESSED AND THE EXACT EXPECTED VOLUME WAS REMOVED. THE PATIENT WAS REFILLED WITH MORPHINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS CANCER PATIENT WAS NEW TO THE CLINIC AND WAS TO HAVE THEIR FIRST REFILL HERE. THE PATIENT WAS NOTED TO HAVE HAD EXPERIENCED SOME ¿MINOR WITHDRAWAL¿ AND HAD TREMORS. UPON ATTEMPTING TO WITHDRAW THE DRUG FROM THE PUMP, NOTHING COULD BE ASPIRATED. THE HEALTH CARE PROVIDER (HCP) WAS CERTAIN THE CORRECT SPOT WAS ACCESSED. THE PUMP WAS NOT ALARMING AND SHOWED THAT THERE SHOULD BE DRUG IN THE RESERVOIR. THE HCP SUSPECTED THERE MAY HAVE BEEN A POCKET FILL AT THE PATIENT'S MOST RECENT REFILL ON AUGUST 15 AT ANOTHER FACILITY. THE PHYSICIAN HAD PLANNED TO PERFORM A DYE STUDY, POSSIBLY A ROLLER STUDY, AND START THE PATIENT BACK UP ON THE MEDICATION AGAIN. THIS DEVICE SYSTEM DELIVERED DILAUDID, BUPIVACAINE, AND CLONIDINE. ADDITIONAL INFORMATION WAS REQUESTED TO VERIFY EVENT RESOLUTION AND THE PATIENT¿S OUTCOME BUT THIS WAS NOT AVAILABLE AT THE TIME OF THE REPORT. SHOULD ADDITIONAL INFORMATION BE RECEIVED A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601016 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00028 YR