BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISTA®

    MDR report key: 6287615 · Received January 30, 2017

    Report

    Report Number
    9610825-2017-00003
    Event Type
    Malfunction
    Date Received
    January 30, 2017
    Report Date
    January 12, 2017
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FRN
    UDI-DI
    04046963988852
    PMA / PMN Number
    K003029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2016018 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 PUMP WAS TESTED 3X AIR SENSOR WITH 0.4ML AIR BUBBLE ALARMED AIR IN LINE 3X DELIVERY ACCURACY CHECK OF 125ML/HR AND 25ML TESTED IN SPEC AT 11 MINUTES 18 SECONDS OR 107% OF EXPECTED ACCURACY. SPEC RANGE IS 11 MINUTES 9.8 SECONDS TO 12 MINUTES 18 SECONDS (OR -2.5 TO +7.5%). NOTE: INCOMING PUMP AIR RATE SET TO 1.5ML/HR; AIR BUBBLE SET TO 0.3ML . BASED ON THE RESULTS OF THE INVESTIGATION, THE PUMP OPERATED AS INTENDED. THE REPORTED DEFECT WAS NOT CONFIRMED. IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2016018 B. BRAUN MEDICAL INC. (BBMI) (IMPORTER) IS SUBMITTING THE REPORT ON BEHALF OF B. BRAUN MELSUNGEN AG (MANUFACTURER). 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.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY: CUSTOMER REPORTS GIVING AN INFUSION TO PATIENT AND NOTED THE BAG AND TUBING WERE COMPLETELY EMPTY; HOWEVER, THE PUMP READ 37.5 MLS LEFT TO BE INFUSED AND THERE HAD NOT BEEN AN ALARM FROM THE PUMP. CUSTOMER BELIEVES THERE SHOULD HAVE BEEN AN AIR IN LINE ALARM AS AIR WAS BELOW PUMP, THERE WAS NO AIR IN LINE ALARM. INFUSION WAS AN IMMUNITY COCKTAIL WHICH IS NORMAL SALINE AND SOME VITAMINS. NO INJURY TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    70193 VISTA® INFUSION PUMP FRN B. BRAUN MELSUNGEN AG 04046963988852

    Patients

    Seq Age Sex Outcome Treatment
    1