BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABBOTT

    MDR report key: 303936 · Received November 7, 2000

    Report

    Report Number
    MW1020358
    Event Type
    Injury
    Date Received
    November 7, 2000
    Date of Event
    July 1, 2000
    Report Date
    October 27, 2000
    Manufacturer
    ABBOTT CORP.
    Product Code
    KZD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    HOSP IMPLEMENTED USE OF THE ABBOTT PUMP 4 MONTH AGO. 200-230 HAVE BEEN IN USE. IN-SERVICE PROVIDED AND TECH SUPPORT. MULTIPLE ISSUES HAVE BEEN IDENTIFIED: 55 DOCUMENTED PROBLEMS. 7 SIGNIFICANT PT RELATED EVENTS. ALL PTS STABILIZED. SUMMARY OF TYPES OF ISSUES: CASSETTE FAILURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOTT INFUSION PUMP KZD ABBOTT CORP. ABBOTT PLUM A+ *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Life Threatening| O