BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3300 PCA SYRINGE PUMP

    MDR report key: 512259 · Received February 17, 2004

    Report

    Report Number
    9612511-2004-00005
    Event Type
    Injury
    Date Received
    February 17, 2004
    Date of Event
    November 24, 2003
    Report Date
    February 9, 2004
    Manufacturer
    GRASEBY MEDICAL LTD.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    ALLEGED THAT PT SUFFERED A IN RESPIRATORY ARREST - POSSIBLY OPIATE INDUCED IN 03. PT ADMITTED IN 11/03 FOR CORRECTIVE SPINAL SURGERY IN TWO STAGES. 3300 PCA PUMP INFUSING MORPHINE SULPHATE 100MG IN 50ML NACI 0.9% (2MG/ML) VIA IV. CONCENTRATION 2MG/ML. PC BOLUS 1MG (0.5ML) DURATION STAT. LOCKOUT 5 MINUTES. BACKGROUND INFUSION NONE. AT TIME OF INCIDENT OBSERVATION CHART SHOWS DEMANDS: TOTAL/GOOD 80/47. NO LONG TERM PT INJURY. OUTCOME FOR PT = GOOD (PT RECOVERED FULLY) - HOSP INVESTIGATION SHOWED THAT NO CONCLUSION CAN BE MADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3300 PCA SYRINGE PUMP SYRINGE PUMP FRN GRASEBY MEDICAL LTD. 3300 PCA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Required Intervention