BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISTA®

    MDR report key: 6984687 · Received October 27, 2017

    Report

    Report Number
    9610825-2017-00214
    Event Type
    Malfunction
    Date Received
    October 27, 2017
    Date of Event
    October 5, 2017
    Report Date
    January 4, 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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2016018 B. BRAUN INC. (BBMI) (IMPORTER) IS SUBMITTING THE REPORT ON BEHALF OF B. BRAUN MELSUNGEN AG (MANUFACTURER). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INC. INTERNAL REPORT NUMBER (B)(4). THE INVESTIGATION INTO THIS REPORTED EVENT IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE RESULTS OF THE INVESTIGATION ARE AVAILABLE.

    Description of Event or Problem · 0

    AS REPORTED BY USER FACILITY: PUMP IS NOT ALARMING OR STOPPING AT THE END OF THE SET INFUSION. BOTH A PRIMARY AND A SECONDARY IV BAG ARE BEING HUNG AT THE SAME TIME. THE IV SOLUTION WAS NORMAL SALINE AND THE PIGGYBACK SOLUTION WAS ARGININE. PATIENT DID NOT RECEIVE AN OVER INFUSION OF MEDICATION AS THE NURSE MANUALLY STOPPED THE PUMP. THE NURSE ALSO NOTED THAT A LARGE AIR BUBBLE FORMED WITHIN THE TUBING. THE LARGE AIR BUBBLE WAS NOTED PRIOR TO REACHING THE PATIENT. NO PATIENT INJURY.

    Additional Manufacturer Narrative · 1

    EXEMPTION NUMBER E2016018. (B)(4). FAILURE ANALYSIS AND INVESTIGATION RESULTS DID NOT CONFIRM THE REPORTED ISSUE. UPON RECEIPT THE ACTUAL PUMP INVOLVED WAS VISUALLY AND FUNCTIONALLY INSPECTED. THREE (3) AIR IN LINE TESTS WERE PERFORMED AND THE PUMP ALARMED AIR IN LINE FOR ALL THREE (3) TESTS. A DELIVERY ACCURACY TEST OF 125 ML/HR AND 25 ML WAS ALSO PERFORMED, AND TESTED IN SPEC. REVIEW OF THE DISCREPANCY MANAGEMENT SYSTEM DATABASE PERFORMED FOR THE REPORTED LOT NUMBER DID NOT REVEAL ANY ABNORMALITIES OR NONCONFORMANCES OF THIS NATURE. NO ADVERSE QUALITY TRENDS OF THIS NATURE WERE IDENTIFIED DURING THE COMPLAINT REVIEW PROCESS FOR THE REPORTED CATALOG NUMBER. THE PUMP OPERATED AS INTENDED AND THE REPORTED FAILURE COULD NOT BE REPRODUCED. BASED ON THE RESULTS OF THE INVESTIGATION, NO CONCLUSIONS CAN BE MADE REGARDING THE CAUSE OF THE REPORTED EVENT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    762968 VISTA® PUMP, INFUSION FRN B. BRAUN MELSUNGEN AG 04046963988852

    Patients

    Seq Age Sex Outcome Treatment
    1