BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED EL

    MDR report key: 477290 · Received August 7, 2003

    Report

    Report Number
    6000030-2003-00695
    Event Type
    Malfunction
    Date Received
    August 7, 2003
    Date of Event
    July 2, 2003
    Report Date
    August 5, 2003
    Manufacturer
    RICE CREEK MFG
    Product Code
    LKK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE HCP REPORTED THAT DURING A PUMP REPLACEMENT SURGERY, HE STARTED TO PULL ON THE PUMP TO REMOVE IT, AND "HE BROKE OFF THE PART OF THE PUMP THAT BECOMES CATHETER ACCESS PORT CONNECTION." THE PUMP WAS REPLACED AND RETURNED TO THE MFR FOR ANALYSIS. THE HCP REPORTS THERE WERE NO PT ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED EL PUMP LKK RICE CREEK MFG 862718 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization CATHETER MODEL 8709 LOT# L62632 IMPLANTED: 1999| EXPLANTED: UNK.