BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 2162106 · Received July 14, 2011

    Report

    Report Number
    6000001-2011-11873
    Event Type
    Malfunction
    Date Received
    July 14, 2011
    Date of Event
    May 31, 2011
    Report Date
    June 17, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K915522
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: EVALUATION SUMMARY: THE CUSTOMER?S REPORTED CONDITION OF A FLO-GARD INFUSION PUMP WITH CLAMP WAS CONFIRMED AND REPRODUCED DURING EVALUATION. THE CAUSE OF THE REPORTED CONDITION WAS DETERMINED TO BE CRACKS ON THE DOOR LATCH. THE DOOR LATCH WAS REPLACED TO FIX THE REPORTED CONDITION.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS REPORTED TO BE AVAILABLE FOR EVALUATION. UPON COMPLETION OF BAXTER?S INVESTIGATION A FOLLOW UP MEDWATCH WILL BE SUBMITTED. (B)(4)

    Description of Event or Problem · 1

    THIS IS A REPORT OF A FLO-GARD PUMP THAT HAD A DOOR CLAMP ISSUE THAT COULD HAVE CAUSED AN INTERRUPTION OF DELIVERY. IT IS UNKNOWN WHEN THE REPORTED CONDITION OCCURRED. THERE WAS NO PATIENT INVOLVEMENT INJURY OR MEDICAL INTERVENTION RELATED TO THIS EVENT. 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