BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2851454 · Received November 29, 2012

    Report

    Report Number
    3004209178-2012-10939
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Report Date
    October 31, 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
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2003, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATED THAT THE PATIENT HAD NO SYMPTOMS, WAS RECEIVING THERAPY, AND WAS DOING FINE NOW. NO ADDITIONAL INFORMATION AS AVAILABLE AT THE TIME OF THIS SUBMISSION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HEALTHCARE PROVIDER (HCP) INJECTED 20ML OF SALINE INTO THE PUMP TO RINSE THE PUMP RESERVOIR. THE HCP DID NOT ASPIRATE THE SALINE AND PROCEEDED TO INJECT 20ML OF DRUG INTO THE RESERVOIR. THE HCP THEN REALIZED THAT SHE HAD NOT WITHDRAWN THE SALINE. THE HCP HAD DILUTED THE DRUG IN THE 40ML SYRINGE AND COULD NOT USE IT. THE HCP THEN DECIDED TO FILL THE PUMP WITH SALINE. THE PUMP WAS PROGRAMMED SALINE AT 1ML/ML AT A DOSE OF ML/DAY. THE HCP PROGRAMMED A BRIDGE BOLUS TO RUN FOR 35 HOURS 9 MINUTES. THE DEVICE SYSTEM WAS PREVIOUSLY USED TO DELIVER FENTANYL, BUPIVACAINE, PRIALT, BACLOFEN AND MORPHINE. 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
    1 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1