BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISTA BASIC - IFVB

    MDR report key: 3111432 · Received April 30, 2013

    Report

    Report Number
    9610825-2013-00114
    Event Type
    Malfunction
    Date Received
    April 30, 2013
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FRN
    PMA / PMN Number
    K003029
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN (B)(4) (MFR). (B)(4). IN A FOLLOW-UP CALL, THE REPORTER WAS TRAVELING AND REFERRED THE CALL TO HIS ASSOCIATE BIOMED AT THE REPORTING FACILITY. THE ASSOCIATE BIOMED WAS UNABLE TO PROVIDE AN EXACT DATE THAT THE INCIDENT OCCURRED ON. HE WAS ALSO UNABLE TO PROVIDE THE RATE THAT THE PUMP WAS SET AT. THE ASSOCIATED DID CONFIRM THAT NO ADVERSE REACTIONS WERE ASSOCIATED WITH THE COMPLAINT. HE STATED THAT THE SET THAT WAS USED IN THE PUMP WAS PRODUCT CODE #V1402. THE ACTUAL PUMP AND LOGS HAVE NOT BEEN RETURNED AT THIS TIME AND THE INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVAL RESULTS ARE AVAILABLE.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188780 VISTA BASIC - IFVB INFUSION PUMP FRN B. BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1