BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2895508 · Received January 3, 2013

    Report

    Report Number
    3004209178-2013-00128
    Event Type
    Malfunction
    Date Received
    January 3, 2013
    Report Date
    December 6, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709, LOT# J11299R25, IMPLANTED: (B)(6) 2002. PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PUMP REFILL, THE HEALTHCARE PROVIDER (HCP) HAD DIFFICULTY ASPIRATING THE RESERVOIR THROUGH THE REFILL PORT. THE HCP FIRST ASPIRATED THE REFILL PORT SUCCESSFULLY OF 5.1ML WHERE LITTLE MORE THAN 5ML WAS EXPECTED. THE HCP CONFIRMED BUBBLE, THEN NO BUBBLES CONFIRMING THAT ALL DRUG WAS ASPIRATED. THE HCP THEN INJECTED 10ML OF DRUG INTO THE RESERVOIR, BUT WAS UNABLE TO ASPIRATE ANYTHING BACK OUT. THE HCP ATTEMPTED TO RE-POSITION THE NEEDLE TO ENSURE THAT THE NEEDLE WAS IN THE PUMP RESERVOIR AND ANOTHER HCP CONFIRMED THE NEEDLE PLACEMENT. IT WAS NOTED THAT THE HCPS HAD NO DIFFICULTY FILLING WITH THE DRUG ALTHOUGH THEY DID NOT EXPERIENCE THE PLUNGER MOVING SLIGHTLY WITH DRUG BEING INITIALLY DRAWN INTO THE PUMP. THE REPORTER STATED THAT DOES NOT NORMALLY HAPPEN WITH THE REFILLS HE DOES. THE HCP FILLED WITH ANOTHER 5ML OF DRUG WITHOUT ANY DIFFICULTIES BUT WAS STILL UNABLE TO ASPIRATE ANY DRUG BACK INTO THE SYRINGE. THE HCP CONSIDERED PERFORMING AN X-RAY OR FLUORO TEST TO CONFIRM THE NEEDLE WAS IN THE RESERVOIR PORT. NO PATIENT SYMPTOMS OR INJURY WERE REPORTED. THE DEVICE SYSTEM WAS USED TO DELIVER GABLOFEN (BACLOFEN). ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2076 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1