BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PCA II PUMP

    MDR report key: 1121823 · Received April 29, 2008

    Report

    Report Number
    6000001-2008-00298
    Event Type
    Malfunction
    Date Received
    April 29, 2008
    Date of Event
    April 4, 2008
    Report Date
    April 24, 2008
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    MEA
    PMA / PMN Number
    K926385
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN MADE AVAILABLE TO BAXTER OF EVAL. A F/U MEDWATCH REPORT WILL BE SUBMITTED SHOULD THE DEVICE BE REC'D AND AN EVAL COMPLETED.

    Description of Event or Problem · 1

    A VOLUNTARY MEDWATCH WAS REC'D IN CORPORATE PROD SURVEILLANCE INVOLVING A PCAII PUMP. THE EVENT IS DESCRIBED AS FOLLOWED: REC'D TRANSFER PT FROM PACU WITH AN ALDRETE SCORE OF 8 OUT OF 10. IV FLUID LR AS BOLUS WAS IN PROGRESS WHILE IN TRANSIT FROM THE PACU. UPON ARRIVAL, THE PCA MACHINE MALFUNCTIONED. THE DOOR WAS AJAR AND SCREEN DISPLAYED "ELECTRICAL MALFUNCTION". STAFF ATTEMPTED TO CORRECT THE PROBLEM WITH DILAUDID 1.8 MG/HR TO PRESCRIBED 1.2 MG/HR. DILAUDID WAS ADMINISTERED AT 0.2 MG/HR, AND THERE WAS AN OVERALL DELAY OF 10 MINS. NO ELECTROPHYSIOLOGY PROCEDURE WAS INVOLVED OR ATTEMPTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PCA II PUMP 80FRN MEA BAXTER HEALTHCARE CORP. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *