BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 3033512 · Received April 3, 2013

    Report

    Report Number
    1416980-2013-08272
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 12, 2013
    Manufacturer
    SHARP CORPORATION OSAKA JAPAN
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED PROBLEM OF FAILURE CODE F38 WAS CONFIRMED DURING DEVICE EVALUATION. SERVICE FOUND THAT THE FORCE SENSING RESISTORS (FSRS) WERE DAMAGED, WHICH CAUSED FAILURE CODE F38. THE FSRS WERE REPLACED TO RESOLVE THE ISSUE. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED CONDITION. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SENT.

    Additional Manufacturer Narrative · 1

    (B)(4). CORRECT MANUFACTURE DATE OF DEVICE FROM NI TO 3/01/1993. (SAME DEVICE AS IN RELATED (B)(4).) SHOULD ADDITIONAL RELEVANT INFORMATION BE RECEIVED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION CODE SET.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER THAT A FLOGARD PUMP DISPLAYED FAILURE CODE F-38. IT IS UNKNOWN WHEN THIS EVENT OCCURRED. NO PATIENT INVOLVEMENT, INJURY OR MEDICAL INTERVENTION WAS REPORTED IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135757 FLOGARD PUMP, INFUSION FRN SHARP CORPORATION OSAKA JAPAN

    Patients

    Seq Age Sex Outcome Treatment
    1