BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AS50 INFUSION PUMP

    MDR report key: 1212463 · Received October 29, 2008

    Report

    Report Number
    6000001-2007-88912
    Event Type
    Malfunction
    Date Received
    October 29, 2008
    Date of Event
    June 19, 2007
    Report Date
    June 22, 2007
    Manufacturer
    BAXTER HEALTHCARE CORPORATION, SINGAPORE
    Product Code
    FPA
    PMA / PMN Number
    K961225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING RESUBMITTED IN ACCORDANCE WITH INSTRUCTIONS FROM THE FDA TO ADDRESS A MANUFACTURER REPORT SEQUENCE NUMBER ISSUE THAT OCCURRED WHEN THIS MDR OR SUPPLEMENT WAS ORIGINALLY SUBMITTED TO THE FDA JULY 20, 2007. DEVICE HAS BEEN REQUESTED FOR EVALUATION. IF DEVICE IS RECEIVED AND EVALUATION PERFORMED, A FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN OVERINFUSION OCCURRED ON THIS PUMP DURING PATIENT USE. PUMP WAS PROGRAMMED TO ADMINISTER A FENTANYL DRIP TO PATIENT. RISK MANAGER THINKS THE PUMP WAS PROGRAMMED TO ADMINISTER 0.1 TO 0.5 ML PER HOUR OF FENTANYL TO THE PATIENT. TREATMENT STARTED IN 2007. PATIENT IS STILL IN THE HOSPITAL. NO ADDITIONAL THERAPY WAS ADMINISTERED TO THE PATIENT DUE TO OVERINFUSION. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION HAS BEEN OBTAINED ON THIS REPORT. NO PATIENT INJURY HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AS50 INFUSION PUMP 80FPA FPA BAXTER HEALTHCARE CORPORATION, SINGAPORE N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1