BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PCA II PUMP

    MDR report key: 1170944 · Received September 24, 2008

    Report

    Report Number
    6000001-2007-01734
    Event Type
    Malfunction
    Date Received
    September 24, 2008
    Date of Event
    December 1, 2006
    Report Date
    December 18, 2006
    Manufacturer
    BAXTER HEALTHCARE (SG)
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    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 TO THE FDA ON JAN 16, 2007. EVALUATION SUMMARY:THE REPORTED CONDITION OF RATES RUNNING HIGH FOR DELIVERY WAS NOT DUPLICATED OR CONFIRMED. AN INSPECTION OF THE DEVICE REVEALED THE PUMP PERFORMED ACCORDING TO SPECIFICATIONS.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE REPORTED THAT DURING PERFORMANCE TESTING (FLOW RATES & DELIEVERY VOLUMES), THE RATES RAN HIGH FOR DELIVERY. THIS WAS FOUND DURING BIO-MED TESTING, WITH NO PATIENT INVOLVEMENT. ALTHOUGH BAXTER ATTEMPTED TO OBTAIN INFORMATION, DETAILS WERE NOT AVAILABLE REGARDING ADDITIONAL CONTACT INFORMATION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PCA II PUMP ANESTHESIA PUMPS FRN BAXTER HEALTHCARE (SG) N/A NA

    Patients

    Seq Age Sex Outcome Treatment
    1