BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PCA II PUMP

    MDR report key: 1022990 · Received April 3, 2008

    Report

    Report Number
    6000001-2007-00026
    Event Type
    Malfunction
    Date Received
    April 3, 2008
    Date of Event
    April 10, 2006
    Report Date
    April 28, 2006
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING RESUBMITTED IN ACCORDANCE WITH INSTRUCTIONS FROM FDA TO ADDRESS A MANUFACTURER REPORT SEQUENCE NUMBER ISSUE THAT OCCURRED WHEN THIS MDR OR SUPPLEMENT WAS ORIGINALLY SUBMITTED. THE DEVICE HAS BEEN REQUESTED BUT HAS NOT BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    A CUSTOMER COMPLETED MEDWATCH WAS RECEIVED WITH THE FOLLOWING INFORMATION: "GIVING MULTIPLE INJECTIONS INDEPENDENT OF PATIENT PRESSING BUTTON. BEEP HEARD WHEN BUTTON IS NOT HELD OR OCCLUDED. 30 INJECTIONS IN ONE HOUR GIVEN. PATIENT REPORTS HAVING ONLY PRESSED BUTTON A FEW TIMES." THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THE REPORT. NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PCA II PUMP ANESTHESIA PUMPS FRN BAXTER HEALTHCARE 2L3104 NA

    Patients

    Seq Age Sex Outcome Treatment
    1