BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3150557 · Received June 6, 2013

    Report

    Report Number
    3004209178-2013-08738
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Report Date
    May 10, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8780, SERIAL # (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE CATHETER; PRODUCT ID 8835, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A NEW PUMP IMPLANT PROCEDURE APPROXIMATELY 17ML OF FLUID WAS EMPTIED FROM THE PUMP RESERVOIR FOLLOWED BY BIG BUBBLES (AS EXPECTED); HOWEVER, THE HEALTHCARE PROVIDER (HCP) ATTEMPTED TO FILL THE PUMP WITH 20ML OF DILAUDID AND WAS ONLY ABLE TO INJECT 15ML. THE VALVE LOCK WAS CHECKED BY ASPIRATING A FEW ML AND THE HCP WAS EASILY ABLE TO ASPIRATE; THEREFORE THE VALVE DID NOT APPEAR TO BE LOCKED. THE HCP INJECTED THE DRUG BACK INTO THE PUMP; HOWEVER, FELT THE DILAUDID MAY HAVE BECOME DILUTED AS THE RESERVOIR MAY HAVE NOT BEEN COMPLETELY EMPTY PRIOR TO THE FILL. TROUBLESHOOTING WAS PERFORMED AND IT WAS DISCUSSED TO PROGRAM THE PUMP RESERVOIR VOLUME AT THE AMOUNT OF DRUG THAT WAS ABLE TO BE INJECTED. THE CALLER WAS TO CONSULT THE HCP. NO PATIENT SYMPTOMS WERE REPORTED. 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
    251310 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1