BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 6109395 · Received November 17, 2016

    Report

    Report Number
    3004209178-2016-24231
    Event Type
    Malfunction
    Date Received
    November 17, 2016
    Date of Event
    November 7, 2016
    Report Date
    December 21, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    UDI-DI
    00643169508156
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PUMP WAS RETURNED WITH A COMPLAINT OF "IT WAS REPORTED PUMP WAS NEVER IMPLANTED BECAUSE WE COULD NOT ASPIRATE THROUGH THE CATHETER ACCESS PORT (CAP)". DURING INTERNAL DECONTAMINATION AND FLOW TEST, RPA WAS ABLE TO FLUSH AND ASPIRATE THRU PUMP CAP WITH NO ISSUE. NO ANOMALIES SEEN. (B)(4).

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE WITH NO PATIENT INVOLVEMENT RELATED TO EVENT. DILAUDID (HYDROMORPHONE) WITH A CONCENTRATION OF 0.5MG FOR A TOTAL DOSE OF 0.1MG AND BUPIVACAINE 10MG FOR A TOTAL DOSE OF 2MG WAS IN THE PUMP AT TIME OF THE EVENT. IT WAS REPORTED PUMP WAS NEVER IMPLANTED BECAUSE WE COULD NOT ASPIRATE THROUGH THE PUMP. ALTERNATIVE SYRINGES WERE USED TO PULL MORE PRESSURE THROUGH THE CATHETER ACCESS PORT (CAP). FLUSHING THROUGH THE CAP ON THE BACK TABLE WAS ATTEMPTED AND WAS UNSUCCESSFUL. IT WAS NOTED ASPIRATING WAS NEGATIVE AND FLUSHING WAS IMPOSSIBLE ON THE BACK TABLE. ISSUE WAS NOTED TO NOT HAVE BEEN RESOLVED AT TIME OF REPORT. PRODUCT WILL BE RETURNED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2016 FROM A MANUFACTURER REPRESENTATIVE. THE PUMP WAS RETURNED WITH NO NEW INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    760426 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-40 00643169508156

    Patients

    Seq Age Sex Outcome Treatment
    1