BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APEX¿

    MDR report key: 7681520 · Received July 12, 2018

    Report

    Report Number
    1641965-2018-00010
    Event Type
    Malfunction
    Date Received
    July 12, 2018
    Date of Event
    June 22, 2018
    Report Date
    September 7, 2018
    Manufacturer
    B. BRAUN MEDICAL INC
    Product Code
    NEP
    UDI-DI
    04046955048502
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INC. INTERNAL REPORT NUMBER (B)(4). THE DEVICE LOGS AND THE TRANSFER SET HAVE BEEN RECEIVED FOR EVALUATION. THE INVESTIGATION IS ONGOING AT THIS TIME. A FOLLOW UP WILL BE SUBMITTED WHEN THE INVESTIGATION RESULTS BECOME AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). SOFTWARE LOGS WERE REVIEWED AND CONFIRMED THE LEAK CHECK EVENT. ONE (1) USED SET, WITHOUT PACKAGING, WAS RETURNED FOR EVALUATION. VISUAL EXAMINATION OF THE SET NOTED THE SET WAS USED, AND NO VISUAL DEFECTS WERE NOTED. THE SET WAS VACUUM LEAK TESTED PER SPECIFICATION WITH PASSING RESULTS. VISUAL EXAMINATION OF A RETAINED UNIT NOTED NO VISUAL DEFECTS. THE SET WAS VACUUM LEAK TESTED PER SPECIFICATION WITH PASSING RESULTS. A REVIEW OF OUR DISCREPANCY MANAGEMENT SYSTEM DATABASE FOUND NO RELATED OR SIMILAR DISCREPANCIES DURING THE PRODUCTION OF THE BATCH. BASED ON THE RESULTS OF THE INVESTIGATION THIS COMPLAINT IS NOT CONFIRMED FOR VALVE MISALIGNMENT. B. BRAUN WILL CONTINUE TO INVESTIGATE, TREND, AND MONITOR ALL COMPLAINTS OF THIS NATURE. IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE A FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    AS PER USER FACILITY: CUSTOMER REPORTED SEVERAL FAILED LEAK CHECK'S. UPON REMOVING THE TRANSFER SET TO INSTALL A NEW ONE IT WAS NOTICED THAT SOME OF THE VALVES ON THE TRANSFER SET WERE SKEWED. NO PATIENT INVOLVEMENT. THE USER REPLACED THE TRANSFER SET WITH NO FURTHER ISSUES.

    Description of Event or Problem · 1

    AS PER USER FACILITY: CUSTOMER REPORTED SEVERAL FAILED LEAK CHEAKS. UPON REMOVING THE TRANSFER SET TO INSTALL A NEW ONE IT WAS NOTICED THAT SOME OF THE VALVES ON THE TRANSFER SET WERE SKEWED. NO PATIENT INVOLVEMENT. THE USER REPLACED THE TRANSFER SET WITH NO FURTHER ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    524413 APEX¿ COMPOUNDER NEP B. BRAUN MEDICAL INC AX1000 04046955048502

    Patients

    Seq Age Sex Outcome Treatment
    1