BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 1061423 · Received June 17, 2008

    Report

    Report Number
    6000030-2008-03287
    Event Type
    Injury
    Date Received
    June 17, 2008
    Date of Event
    May 1, 2008
    Report Date
    May 19, 2008
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-0956-2008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO THE MANUFACTURER FOR ANALYSIS WHICH IS NOT COMPLETE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    THE PATIENT SHOWED UNSPECIFIED SIGNS OF UNDERINFUSION. THE PUMP WAS FILLED WITH 15 MLS; AT THE NEXT REFILL, THE HCP FOUND ALL 15 MLS. A ROTOR TEST WAS DONE (DATE NOT REPORTED); IT WAS NOT POSSIBLE TO IDENTIFY THE ROTOR POSITION WITH FLUOROSCOPY (POOR RESOLUTION). CATHETER ACCESSIBILITY WAS TESTED DURING IMPLANT REVISION AND APPEARED ACCESSIBLE AND WELL POSITIONED. A BOLUS OF 5 MINUTES AND 0.12 MLS WAS PROGRAMMED DURING THE REVISION, BUT NO DROP WAS SEEN COMING OUT OF THE SIDE PORT; THE HCP SUSPECTED A ROTOR STALL. THE PUMP WAS REPLACED. NO ALARMS WERE ONGOING. THE HCP PROGRAMMED A STOPPED PUMP AFTER EXPLANT. THERE WAS NO PATIENT INJURY. THE PATIENT WAS DOING WELL WITH THE NEW PUMP. THE PUMP WAS USED TO DELIVER CATAPRESAN AND MIDAZOLAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED EL LKK RICE CREEK MANUFACTURING 8627 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CATHTER MODEL UNK LOT# UNK