BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3051395 · Received April 10, 2013

    Report

    Report Number
    3004209178-2013-05948
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Report Date
    March 14, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8781 LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE CATHETER PRODUCT ID: 8840 LOT# SERIAL# UNKNOWN, PRODUCT TYPE PROGRAMMER, PHYSICIAN. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8870, IMPLANTED: NA, EXPLANTED: NA; PRODUCT TYPE SOFTWARE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HEALTH CARE PROVIDER (HCP) REFILLED THE PATIENT'S PUMP AND EVERYTHING WAS NOTED TO BE FINE; HE "GOT THE RIGHT AMOUNT OUT AND PUT THE RIGHT AMOUNT IN". WHEN THE HCP WENT TO CHANGE THE SETTINGS AND TO INTERROGATE THE PUMP, IT SAID THERE WAS A PUMP MEMORY ERROR AND THAT THE PUMP AND CATHETER DATA WERE INVALID; THEN IT WOULD NOT LET HIM CHANGE ANYTHING. IT WAS NOTED THAT THERE WAS AN OLDER SOFTWARE CARD IN THE PROGRAMMER THAT DID NOT RECOGNIZE THE NEW ASCENDA CATHETER. THE HCP WAS ABLE TO PROGRAM THE PUMP BY ENTERING "OTHER" FOR THE CATHETER INFORMATION AND BY MANUALLY TYPING IN THE CATHETER VOLUME; THE PUMP WAS UPDATED SUCCESSFULLY. THE PUMP SYSTEM WAS BEING USED TO DELIVER DILAUDID AND MARCAINE. THE HCP PLANNED TO GET AN UPDATED SOFTWARE CARD FOR THE PHYSICIAN PROGRAMMER. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE HCP STATED THERE WAS NEVER AN ISSUE WITH THE PATIENT. THE HCP RECEIVED THE UPDATED SOFTWARE CARD ON AN UNSPECIFIED DATE, AND THE 8840 WAS UPDATED APPROPRIATELY WITH NO ISSUE. THE SERIAL NUMBER WAS NOT AVAILABLE. THE PATIENT WAS NOTED TO BE ¿FINE¿ AND WAS RECEIVING EFFECTIVE THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149820 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1