BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT SPACE

    MDR report key: 6228240 · Received January 6, 2017

    Report

    Report Number
    9610825-2016-00955
    Event Type
    Malfunction
    Date Received
    January 6, 2017
    Report Date
    December 22, 2016
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FRN
    UDI-DI
    04046963716752
    PMA / PMN Number
    K062700
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2011009. B. BRAUN MEDICAL INC. IS SUBMITTING A SINGLE REPORT ON BEHALF OF B. BRAUN MELSUNGEN (THE MANUFACTURER), AND B. BRAUN MEDICAL INC. (THE IMPORTER). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). THE DEVICE INVOLVED HAS BEEN RECEIVED FOR EVALUATION AND THE INVESTIGATION IS ONGOING AT THIS TIME. A FOLLOW UP WILL BE SUBMITTED WHEN THE INVESTIGATION RESULTS BECOME AVAILABLE.

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2011009. B. BRAUN MEDICAL INC. IS SUBMITTING A SINGLE REPORT ON BEHALF OF B. BRAUN MELSUNGEN (THE MANUFACTURER), AND B. BRAUN MEDICAL INC. (THE IMPORTER). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). THE VOLUMETRIC ACCURACY WAS TESTED 3X BOLUS OF 1200ML/HR AND 10ML DELIVERED CORRECTLY IN 30 SECONDS AND THE PUMP TESTED IN SPECIFICATIONS. THE PUMP'S OPERATIONAL LOG WAS REVIEWED AND THERE WERE NO INDICATION THAT THE PUMP MALFUNCTIONED. BASED ON THE RESULTS OF THE INVESTIGATION, THE PUMP OPERATED AS INTENDED. IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY: REPORTED: POSSIBLE OVERINFUSION, PUMP OVERINFUSED MORE THAN PROGRAMMED AMOUNT. SPOKE WITH CUSTOMER: ATTEMPTED TO DO BOLUS OF 10 ML. PUMP NEVER COUNTED BOLUS DOWN, BUT INFUSED ENTIRE BAG AT RAPID RATE. THERE HAD BEEN NO PATIENT ISSUES REPORTED REGARDING PUMP ALL ISSUES FOUND IN BIOMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12301 INFUSOMAT SPACE INFUSION PUMP FRN B. BRAUN MELSUNGEN AG 04046963716752

    Patients

    Seq Age Sex Outcome Treatment
    1