BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3200327 · Received July 1, 2013

    Report

    Report Number
    3004209178-2013-11148
    Event Type
    Malfunction
    Date Received
    July 1, 2013
    Date of Event
    June 6, 2013
    Report Date
    June 6, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PUMP REFILL THE HEALTHCARE PROVIDER (HCP) ASPIRATED APPROXIMATELY 5ML OF CLEAR FLUID THEN BEGAN PULLING BACK ¿PINKISH CREAM COLOR¿ FLUID OUT OF THE PUMP RESERVOIR. THE HCP DESCRIBED THE FLUID ¿THIS LOOKS LIKE A MANGO DRINK.¿ THE HCP STATED THAT THE PATIENT HAD CANCER IN THE RIGHT HIP RIGHT NEXT TO HER PUMP AND SHE HAD BEEN PUTTING ICE OVER THAT AREA BUT HAD NOT PUT ANY ICE OVER HER PUMP. THE HCP WONDERED IF THE COLD HAD BROKEN DOWN THE DRUG. THERE WERE NO PATIENT SYMPTOMS REPORTED. THE DEVICE SYSTEM DELIVERED DILAUDID AND BUPIVACAINE. IT WAS LATER REPORTED THAT THE HCP BELIEVED THE EVENT WAS DUE TO THE PATIENT PLACING ICE OVER THE PUMP FOR LONG PERIODS OF TIME. NO PATIENT SIGNS OR SYMPTOMS REPORTED. PATIENT OUTCOME WAS REPORTED AS NO INJURY AND RECOVERED WITHOUT SEQUELAE. CONFLICTING INFORMATION WAS PROVIDED THAT THE DEVICE SYSTEM ALSO DELIVERED COMPOUNDED BACLOFEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299703 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00037 YR