BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 2223374 · Received August 25, 2011

    Report

    Report Number
    6000001-2011-20642
    Event Type
    Malfunction
    Date Received
    August 25, 2011
    Date of Event
    July 31, 2011
    Report Date
    August 18, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K915522
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE REPORTED CONDITION OF A FLO GARD INFUSION PUMP WITH A BROKEN CORD WAS NOT CONFIRMED DURING PRODUCT EVALUATION. ALSO, THE QUALITY ENGINEER HAS DETERMINED THE CAUSE TO BE NOT IDENTIFIED. SINCE NO ASSIGNABLE CAUSE WAS PROVIDED DURING PRODUCT EVALUATION, NO REPAIR WAS NECESSARY OR PERFORMED FOR THE REPORTED CONDITION. THE DEVICE HISTORY RECORD REVIEW SHOWS PUMP DATA CARD DISCARDED PER DOC. 20J RETENTION PERIOD. THE DEVICE HAS NOT BEEN PREVIOUSLY SENT INTO SERVICE FOR THE REPORTED CONDITION OF BROKEN CORD.

    Additional Manufacturer Narrative · 1

    (B)(4). PER THE CUSTOMER, THE DEVICE IS AVAILABLE FOR EVALUATION; HOWEVER, THE DEVICE HAS NOT YET BEEN RECEIVED BY BAXTER. SHOULD THE DEVICE OR ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE REPORTED A FLO-GARD INFUSION PUMP WITH A BROKEN CORD. THIS CONDITION WAS FOUND DURING BIOMED TESTING IN THE BIOMED SERVICE AREA. THIS CONDITION HAS THE POTENTIAL TO INTERRUPT DELIVERY. THE FACILITY REPRESENTATIVE STATED THAT THERE WAS NO INFORMATION REGARDING PATIENT INVOLVEMENT, PATIENT INJURY OR MEDICAL INTERVENTION. THE DEVICE WAS ALSO BEING RETURNED FOR FINAL RENTAL RETURN. NO ADDITIONAL INFORMATION IS AVAILABLE.

    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