BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2822942 · Received November 7, 2012

    Report

    Report Number
    3007566237-2012-02650
    Event Type
    Malfunction
    Date Received
    November 7, 2012
    Date of Event
    October 1, 2012
    Report Date
    October 10, 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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8840, PRODUCT TYPE: PROGRAMMER, PHYSICIAN. (B)(4).

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING SITE ID WAS PREVIOUSLY REPORTED AS #3007566237. ADDITIONAL INFORMATION INDICATES THE CORRECT MANUFACTURING SITE ID IS #3004209178.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8870, PRODUCT TYPE: SOFTWARE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED UPON INTERROGATION THE PUMP SHOWED INVALID PUMP AND CATHETER DATA AND THEY COULD NOT PROGRESS IN THE SCREENS. THE PRINT OFF SHOWED A PUMP MEMORY ERROR. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE PATIENT HAD FOLLOWED UP WITH HIS PHYSICIAN AND WAS DOING "VERY WELL". THE DRUG USED IN THIS SYSTEM WAS LIORESAL. ADDITIONAL REVIEW INDICATED THAT THE INFORMATION REGARDING THE "INVALID PUMP AND CATHETER DATA" DID NOT PERTAIN TO THIS REPORT. SEE MANUFACTURER'S REPORT #3004209178-2012-10049 FOR DETAILS INVOLVING THIS ERROR.

    Description of Event or Problem · 1

    ADDITIONAL REVIEW INDICATED THE PREVIOUSLY REPORTED ¿INVALID PUMP AND CATHETER DATA¿ DID PERTAIN TO THIS REPORT. ADDITIONAL INFORMATION RECEIVED REPORTED THE PROBLEM WAS WITH THE PROGRAMMER SOFTWARE CARD. THE INVALID CATHETER AND PUMP READING WAS DUE TO AN OLDER SOFTWARE APPLICATION CARD THAT COULD NOT READ THE NEW CATHETER THAT HAD JUST BEEN IMPLANTED. THE PUMP SYSTEM WAS BEING USED TO DELIVER LIORESAL.

    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 00044 YR