BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APEX¿

    MDR report key: 7480266 · Received May 2, 2018

    Report

    Report Number
    1641965-2018-00006
    Event Type
    Malfunction
    Date Received
    May 2, 2018
    Date of Event
    April 16, 2018
    Report Date
    June 29, 2018
    Manufacturer
    B. BRAUN MEDICAL INC
    Product Code
    NEP
    UDI-DI
    04046955048502
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INC. INTERNAL REPORT NUMBER (B)(4). ONE (1) USED TRANSFER SET, WITH PACKAGING, WAS RETURNED FOR EVALUATION. VISUAL EXAMINATION OF THE TRANSFER SET NOTED NO VISUAL DEFECTS. THE SET WAS VACUUM LEAK TESTED PER SPECIFICATION WITH PASSING RESULTS. THE SET WAS LEAKAGE TESTED PER SPECIFICATION WITH PASSING RESULTS. ADDITIONALLY, LINES 9 AND 13 WERE EACH PRESSURIZED AT 10 PSI, AND THE VALVES WERE OPENED AND CLOSED. NO LEAKAGE WAS NOTED. THE IOG REVIEW SHOWS AT AROUND 10:51AM A SITUATION WHERE THE SOLUTION ON VALVE 9 (MAG SULFATE) SEEMS TO HAVE A LOT OF BUBBLES FOR A PARTICULAR ORDER. A MANIFOLD FLUSH WAS DONE AND THEN PRIMING OF SEVERAL INGREDIENTS (STATION 6, STATION 7 THREE TIMES, STATION 8, STATION 9 FIVE TIMES). THIS IS BELIEVED TO BE WHEN THE ODD BEHAVIOR, WAS NOTICED WHICH WAS DESCRIBED AS SEEPING UP VALVE 13. THERE IS NO ATTEMPT TO PUMP VALVE 13 AFTER THIS. THERE'S NO EVIDENCE OF HANGING THE WRONG THING ON STATION 9 OR STATION 13, AND NO OCCLUSIONS OR EXCESSIVE BUBBLES OTHER THAN DURING THAT ONE ORDER, AND THE SOLUTIONS DO NOT SEEM TO RUN OUT FASTER THAN EXPECTED. THERE IS NO CLEAR REASON WHY THIS EVENT OCCURRED. BASED ON THE REVIEW OF THE SOFTWARE LOGS AND A THOROUGH INVESTIGATION OF THE TRANSFER SET, THIS PARTICULAR DEFECT CANNOT BE CONFIRMED. IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE A FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 0

    AS PER USER FACILITY: DURING PRIMING OF MICRO LINE 9 (MAGNESIUM SULFATE) AND MICRO LINE 13 (5C) BUBBLES WERE OBSERVED IN THE TUBING. THE CUSTOMER INDICATED THIS ONLY OCCURS WHEN INITIALLY PRIMING MICRO LINE 9 WITH MAGNESIUM SULFATE. MICRO LINE 9 WILL SEEP INTO LINE 13. NO PATIENT INVOLVEMENT. THE USER REPLACED THE TRANSFER SET WITH NO FURTHER ISSUES.

    Additional Manufacturer Narrative · 1

    (B)(4). THE INVESTIGATION IS ONGOING AT THIS TIME. A FOLLOW-UP WILL BE SUBMITTED WHEN THE INVESTIGATION RESULTS BECOME AVAILABLE.

    Description of Event or Problem · 1

    AS PER USER FACILITY: DURING PRIMING OF MICRO LINE 9 (MAGNESIUM SULFATE) AND MICRO LINE 13 (5C) BUBBLES WERE OBSERVED IN THE TUBING. THE CUSTOMER INDICATED THIS ONLY OCCURS WHEN INITIALLY PRIMING MICRO LINE 9 WITH MAGNESIUM SULFATE. MICRO LINE 9 WILL SEEP INTO LINE 13. NO PATIENT INVOLVEMENT. THE USER REPLACED THE TRANSFER SET WITH NO FURTHER ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323562 APEX¿ COMPOUNDER NEP B. BRAUN MEDICAL INC AX1000 04046955048502

    Patients

    Seq Age Sex Outcome Treatment
    1