BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT®

    MDR report key: 6636454 · Received June 13, 2017

    Report

    Report Number
    9610825-2017-00113
    Event Type
    Malfunction
    Date Received
    June 13, 2017
    Date of Event
    May 25, 2017
    Report Date
    May 26, 2017
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FRN
    UDI-DI
    04046964660887
    PMA / PMN Number
    K142596
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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: AIR BUBBLES WERE NOTED IN LINE ABOVE THE PUMP, ON THE PRIMARY SET. THERE WAS A SECONDARY SET ATTACHED FOR AN IVPB TO BE INFUSED OF 2 GRAMS CESTRIAXONE/ DEXTROSE. AIR NOTICED BEYOND THE UPPER Y PORT GOING TOWARDS PUMP, MORE AIR NOTICED IN THE LINE LOADING GUIDE SEGMENT, AIR BUBBLES CONTINUE DOWN THE IV SET THROUGHOUT. ALARM WAS SOUNDING WITH SIGNIFICANT AMOUNT OF AIR IN TUBING DISTAL TO PUMP. ABOUT 60 PERCENT OF THE INFUSION WAS INFUSED AT TIME NOTICED AIR. PUMP AND TUBING WERE TAKEN OUT OF SERVICE. 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. AN AIR IN LINE TEST WAS PERFORMED WITH A .4ML AIR BUBBLE, AND THE PUMP ALARMED AIR IN LINE AS INTENDED. 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
    418316 INFUSOMAT® PUMP, INFUSION FRN B. BRAUN MELSUNGEN AG 04046964660887

    Patients

    Seq Age Sex Outcome Treatment
    1