BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 2941560 · Received February 4, 2013

    Report

    Report Number
    1416980-2013-02774
    Event Type
    Malfunction
    Date Received
    February 4, 2013
    Date of Event
    December 27, 2012
    Report Date
    December 27, 2012
    Manufacturer
    SHARP CORPORATION OSAKA JAPAN
    Product Code
    FRN
    PMA / PMN Number
    K915522
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    SERVICE AND TESTING PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS SERVICED ON-SITE BY A FIELD SERVICE TECHNICIAN. THIS IS AN ANCILLARY SERVICE EVENT OPENED DURING INVESTIGATION OF (B)(4). THE ROOT CAUSE OF THE DAMAGED SAFETY CLAMP SHIM IS UNKNOWN. TO CORRECT THE CONDITION, THE SAFETY CLAMP SHIM WAS REPLACED. THE DEVICE WAS SERVICED AND RESTORED TO A GOOD WORKING CONDITION. IF ANY RELEVANT ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP MDR WILL BE SENT.

    Description of Event or Problem · 1

    DURING PRODUCT EVALUATION BY A BAXTER SERVICE TECHNICIAN, A FLO-GARD INFUSION PUMP WAS FOUND TO HAVE A DAMAGED SAFETY CLAMP SHIM. THIS CONDITION HAD THE POTENTIAL TO INTERRUPT DELIVERY. THIS WAS NOT REPORTED BY THE CUSTOMER. THERE WAS NO PATIENT INVOLVEMENT; THEREFORE, NO PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE REACTION IS ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47183 FLOGARD PUMP, INFUSION FRN SHARP CORPORATION OSAKA JAPAN

    Patients

    Seq Age Sex Outcome Treatment
    1