BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SABRATEK 6060 HOMERUN PUMP

    MDR report key: 658799 · Received September 2, 2005

    Report

    Report Number
    6000001-2005-03632
    Event Type
    Malfunction
    Date Received
    September 2, 2005
    Date of Event
    December 1, 2003
    Report Date
    March 12, 2004
    Manufacturer
    BAXTER HEALTHCARE (SG)
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    BAXTER RECEIVED MEDWATCH IN 2004 #1030555. DATE OF MEDWATCH REPORT IS THREE MONTHS EARLIER. CUSTOMER REPORTED PUMP WAS ALARMING AFTER BEING TURNED OFF AND BACK ON. PUMP DID NOT INFUSE MEDICATION TO CUSTOMER. A NEW PUMP HAS BEEN SENT TO PT. NO PT INJURY HAS BEEN REPORTED AT THIS TIME. NO ADDITIONAL PT OR PUMP INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SABRATEK 6060 HOMERUN PUMP SABRATEK 6060 PUMP FRN BAXTER HEALTHCARE (SG) NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN