BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 472647 · Received July 17, 2003

    Report

    Report Number
    6000030-2003-00597
    Event Type
    Injury
    Date Received
    July 17, 2003
    Date of Event
    June 17, 2003
    Report Date
    June 17, 2003
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    HCP REPORTS PHYSICIAN CONSULTED WITH MANUFACTURER'S PERSONNEL TO PERFORM A BRIDGE BOLUS. LATER, PHYSICIAN CONSULTED MANUFACTURER'S STAFF AGAIN FOLLOWING A PROGRAMMING ERROR. THE PUMP WAS PROGRAMMED TO GIVE A BOLUS OVER 21 MINUTES INSTEAD OF 21 HOURS. THE PT BECAME VERY EXCITED AS PT COULDN'T FEEL THE LEGS; THEY FELT NUMB. IT WAS DECIDED TO STOP THE PUMP IMMEDIATELY. THE PT WAS IMMEDIATELY TAKEN TOE THE HOSP BY AMBULANCE AND ADMITTED TO THE INTENSIVE CARE UNIT. THE PT REMAINED IN THE HOSP FOR A COUPLE OF DAYS FOR OBSERVATION. THE PT WAS REPORTED AS HAVING SOME SHORT TERM MEMORY LOSS BUT DOING FINE TODAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED EL PUMP LKK RICE CREEK MANUFACTURING 8627L18 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization CATHETER MODEL 8709 LOT# J11397R54 IMPLANTED: 2002| EXPLANTED: UNK.