BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSTANT FLOW IMPLANTABLE PUMP

    MDR report key: 337402 · Received June 12, 2001

    Report

    Report Number
    1221409-2001-00015
    Event Type
    Injury
    Date Received
    June 12, 2001
    Report Date
    June 6, 2001
    Manufacturer
    ARROW INTERNATIONAL, INC.
    Product Code
    LKK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IMMEDIATELY AFTER THE PUMP REFILL PROCEDURE, THE ENTIRE 30ML OF MORPHINE/CARBO/NCL WAS INFUSED INTO THE SPINAL SPACE IN A TWO MINUTE PERIOD. THE PT DEVELOPED RESPIRATORY DEPRESSION. PT WAS SUBSEQUENTLY INTUBATED AND TAKEN TO ICU. AFTER ONE DAY OF RESPIRATORY THERAPY, THE PT RECOVERED. THERE WERE NO FURTHER COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26845 CONSTANT FLOW IMPLANTABLE PUMP IMPLANTABLE INFUSION PUMP LKK ARROW INTERNATIONAL, INC. NA 9616

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention