BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PCA INFUSOR

    MDR report key: 53623 · Received December 5, 1996

    Report

    Report Number
    MW1010370
    Event Type
    Injury
    Date Received
    December 5, 1996
    Date of Event
    October 9, 1996
    Report Date
    November 25, 1996
    Manufacturer
    IVAC MEDICAL SYSTEMS
    Product Code
    MEA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT HAD SURGERY ON 10/9/96 FOR TOTAL KNEE REPLACEMENT. PCA PUMP WAS INITIATED IN REC ROOM AT 1400. 60 CC SYRINGE OF MORPHINE 1MGM/CC WAS INITIATED WITH O LOADING DOSE. CONTINUOUS FLOW 2MGM/HR. PT REQUESTED DOSE OF 0.2 MGM. LOCKOUT INTERNAL WAS 6 MIN. AT 1600 4.3 MGM HAD INFUSED WITH 4 INJECTIONS AND 4 ATTEMPTS PER PUMP CONTROLS. AT 1640 THE SYRINGE WAS EMPTY WITH 55.7 MGM INFUSED IN 40 MIN. THE PUMP CONTROLS READ 1.3 MGM INFUSED AT O ATTEMPTS AND O INJECTIONS. PT WAS GROGGY AND LETHARGIC. PT RECEIVED NARCAN 2 MGM IVP X 2 VITAL SIGNS STABILIZED. NO ADVERSE OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PCA INFUSOR PATIENT CONTROLLED PUMP MEA IVAC MEDICAL SYSTEMS 310 *

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention