BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    B. BRAUN

    MDR report key: 8154852 · Received December 12, 2018

    Report

    Report Number
    9610825-2018-00262
    Event Type
    Malfunction
    Date Received
    December 12, 2018
    Report Date
    January 29, 2019
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    MRZ
    UDI-DI
    04046964085673
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE 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 USED POWER SUPPLY WAS RECEIVED FOR EVALUATION, AND DURING THE INITIAL VISUAL EXAMINATION IT WAS DISCOVERED THAT THE POWER SUPPLY EXHIBITED SIGNS OF THERMAL DAMAGE. UPON FURTHER EVALUATION, IT WAS DETERMINED THAT THE PINS ONTHE PRIMARY ADAPTOR WERE DAMAGED IN A WAY THAT CAUSED THEM TO LOSE CONNECTION WITH THE BOARD INSIDE THE POWER SUPPLY. THE LOOSE CONNECTION BETWEEN THE PINS AND THE INTERNAL BOARD OF THE POWER SUPPLY CAUSED THE THERMAL DAMAGE. BASED ON THE CONDITION OF THE POWER SUPPLY WHEN IT WAS RECEIVED, THE CAUSE OF THE DISCONNECTION WAS MOST LIKELY THE RESULT OF THE POWER SUPPLY BEING DROPPED SEVERAL TIMES. NO ADVERSE QUALITY TRENDS OF THIS NATURE WERE IDENTIFIED DURING THE COMPLAINT REVIEW PROCESS FOR THE REPORTED CATALOG NUMBER. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    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. THE DEVICE HAS BEEN FORWARDED TO B. BRAUN MELSUNGEN AG (MANUFACTURER) TO COMPLETE THE INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE RESULTS OF THE INVESTIGATION ARE AVAILABLE.

    Description of Event or Problem · 0

    THE POWER SUPPLY WAS ORIGINALLY REPORTED AS DAMAGED. ONCE THE POWER SUPPLY WAS RECEIVED BY (B)(4), IT WAS VISUALLY INSPECTED AND IT WAS DISCOVERED THAT THE POWER SUPPLY EXHIBITED SIGNS OF THERMAL DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    996916 B. BRAUN ACCESSORIES, PUMP, INFUSION MRZ B. BRAUN MELSUNGEN AG 04046964085673

    Patients

    Seq Age Sex Outcome Treatment
    1