BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 2830330 · Received November 13, 2012

    Report

    Report Number
    1416980-2012-04974
    Event Type
    Malfunction
    Date Received
    November 13, 2012
    Date of Event
    October 19, 2012
    Report Date
    October 19, 2012
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K915522
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED PROBLEM OF "ALARM F-38" WAS CONFIRMED. SERVICE DETERMINED THAT THE FORCE SENSING RESISTORS WERE OUT OF SPECIFICATION. THE RESISTORS WERE REPLACED TO RESOLVE THE ISSUE. ADDITIONAL INFORMATION: A SERVICE HISTORY REVIEW WAS PERFORMED REVEALING THE REPORTED CONDITION IS NOT RELATED TO ANY PREVIOUS CUSTOMER SERVICE REQUEST ON THIS PUMP. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THIS IS A CASE REPORT FROM A CUSTOMER RECEIVED ON (B)(4) 2012, BY BAXTER (B)(4) TECHNICIAN. IT WAS REPORTED THAT ON (B)(6) 2012 A PUMP PRESENTED THE ALARM F-38. IT IS UNKNOWN IF THIS ALARM OCCURRED DURING PATIENT USE; HOWEVER, NO MEDICAL INJURY OR ADVERSE EVENT WAS REPORTED. ADDITIONAL INFORMATION IS NOT EXPECTED.

    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