BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT SPACE US

    MDR report key: 2031691 · Received February 24, 2011

    Report

    Report Number
    2523676-2011-00016
    Event Type
    Malfunction
    Date Received
    February 24, 2011
    Date of Event
    January 17, 2011
    Report Date
    February 21, 2011
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Product Code
    FRN
    PMA / PMN Number
    K062699
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO THE MFR TO BE EVALUATED. NO VISUAL MFG ABNORMALITIES WERE NOTED. AS PART OF THE INITIAL EVAL OF THIS PUMP PER THE PROCEDURE FOR COMPLAINT RETURNS, THE PUMP'S DELIVERY ACCURACY WAS TESTED THREE TIMES. TEST RESULTS WERE WITHIN SPEC. THE REPORTED FAILURE OF AN OVER-INFUSION WAS NOT CONFIRMED. THIS DEVICE IS STILL UNDER INVESTIGATION. A FOLLOW-UP REPORT WILL BE FILED WHEN THE PUMP INVESTIGATION IS COMPLETED AND ADD'L INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: REPORTS OVERINFUSION. NO PT INJURY, BAG EMPTY BEFORE EXPECTED TIME. CUSTOMER DID NOT HAVE ANY DETAILS OF INFUSION. NO DISPOSABLES SAVED. NO NOTIFICATION RECEIVED ABOUT WHEN PUMP LAST SERVICED. ADD'L INFO PROVIDED BY THE FACILITY INDICATED THE PT SUFFERED NO ADVERSE SEQUELA ASSOCIATED WITH THE REPORTED INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSOMAT SPACE US INFUSION PUMP FRN B. BRAUN MEDICAL, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1