BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AP II PUMP

    MDR report key: 355035 · Received October 4, 2001

    Report

    Report Number
    6000001-2001-00439
    Event Type
    Injury
    Date Received
    October 4, 2001
    Date of Event
    September 1, 2001
    Report Date
    September 13, 2001
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD
    Product Code
    MEA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    RECEIVED VOLUNTARY MEDWTACH LETTER FORWARDEDBY FDA, REFERENCE NUMBER MW 1022715, WITH INFO THAT STATES PCA TUBING WAS KINKED, DID NOT ALARM AND PT'S PAIN WAS UNRELIEVED. RISK MGR OF FACILITY STATED THAT PT DID NOT RECEIVE PAIN MEDICATION FOR FOUR DAYS. AFTER FOUR DAYS A KINK WAS THEN DISCOVERED IN THE TUBING. KINK OCCURRED UPSTEAM OF THE PUMP. RISK MGR STATED THAT PUMP HAD NOT BEEN ISOLATED AND TUBING HAD NOT BEEN SAVED FOR ANALYSIS. ADD'L INFO THE ACCOUNT: PT WAS TREATED WITH NIPRIDE AND ISMELIN FOR HYPERTENSION THAT POSSIBLY COULD BE RELATED TO THE UNRELIEVED PAIN DUE TO NON DELIVERY OF MORPHINE. FACILITY REPORTS PT RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44825 AP II PUMP PCA PUMP MEA BAXTER HEALTHCARE PTE. LTD NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention