BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 1914885 · Received December 6, 2010

    Report

    Report Number
    6000001-2010-05546
    Event Type
    Malfunction
    Date Received
    December 6, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 17, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K915522
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. SHOULD THE DEVICE BE RECEIVED BY BAXTER FOR EVALUATION, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVALUATION OR IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE CONDITION OF A FLOGARD INFUSION PUMP THAT EXPERIENCED A FALSE OCCLUSION ALARM WAS CONFIRMED AND REPRODUCED DURING PRODUCT EVALUATION; HOWEVER, THE CAUSE OF THIS CONDITION WAS NOT IDENTIFIED. THERE WERE NO REPAIRS COMPLETED FOR THIS DEVICE AS THE CUSTOMER DID NOT APPROVE REPAIR ESTIMATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED. ADDITIONAL INFO: BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. A SERVICE HISTORY REVIEW WAS PERFORMED REVEALING THE REPORTED CONDITION IS NOT RELATED TO ANY PREVIOUS CUSTOMER SERVICE REQUEST ON THIS PUMP. THIS DEVICE WAS RECEIVED BY BAXTER ON (B)(6) 2010.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A FLO-GARD INFUSION PUMP WHICH EXPERIENCED AN OCCLUSION ALARM DURING SET-UP. THIS CONDITION MAY BE A FALSE OCCLUSION ALARM. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLOGARD PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1