BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APEX¿

    MDR report key: 7236644 · Received February 2, 2018

    Report

    Report Number
    1641965-2018-00001
    Event Type
    Malfunction
    Date Received
    February 2, 2018
    Date of Event
    January 12, 2018
    Report Date
    June 28, 2018
    Manufacturer
    B. BRAUN MEDICAL INC
    Product Code
    NEP
    UDI-DI
    04046955048502
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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). REVIEW OF THE LOGS DID NOT INDICATE A LEAK DURING LEAK CHECK, AND LEAK CHECK WAS NOT DISABLED. THE USER SUCCESSFULLY PRIMES EVERY OTHER STATION ON FLEX, MACRO AND MICRO CHANNELS EXCEPT FOR ONE FLEX STATION. THE USER CANNOT PRIME ONE FLEX STATION ON THE MICRO SIDE DUE TO OCCLUSIONS, DESPITE TRYING OVER A DOZEN TIMES. EVENTUALLY THEY NOTICE, WHEN A SOLUTION WITH OBVIOUS COLORATION IS PRIMED, THAT THERE IS INTERMIXING ON THE MICRO LINE THAT WAS OCCLUDING, AND THAT IT LOOKS LIKE THE MICRO LINE THAT WAS OCCLUDING WAS PUMPING EVEN WHEN A DIFFERENT STATION WAS PUMPING. THE TRANSFER SET WAS RETURNED AND THE MICRO VALVE # 7 WAS CONFIRMED TO BE 180 DEGREES OUT OF PHASE, THEREFORE LEADING TO OCCLUSIONS AND THE POTENTIAL FOR CROSS CONTAMINATION. THE INVESTIGATION INTO THE REPORTED ISSUE CONFIRMED THAT IT IS POSSIBLE TO HAVE A PARTIALLY MISALIGNED VALVE WHICH IS NOT DETECTED DURING THE 100% LEAKAGE TESTING PERFORMED DURING MANUFACTURING OF THE SET. ADDITIONAL INVESTIGATIONS ARE BEING DONE TO DETERMINE THE ROOT CAUSE OF THIS NATURE. THE INITIAL REPORT WAS FILED AGAINST THE PRODUCT AX1000, APEX COMPOUNDING SYSTEM. THE INVESTIGATION HAS DETERMINED THAT THE MISALIGNED VALVE OF PRODUCT 2112550, APEX TRANSFER SET, IS THE MOST PROBABLE CAUSE OF THIS INCIDENT. MEDWATCH (B)(4) HAS BEEN FILED FOR THE TRANSFER SET. IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE A FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 0

    AS PER USER FACILITY: WHEN INITIALLY PRIMING PORT 7 (POTASSIUM CHLORIDE) OCCLUSIONS WERE RECEIVED. CUSTOMER WAS ABLE TO GET PAST THE OCCLUSIONS AFTER TROUBLESHOOTING AND POWER-CYCLING THE PUMP. UPON PRIMING PORT 19 (ADULT MVI), AND PRIMING VERY SLOW, IT WAS NOTICED THE PORT 7 MICRO SIDE LOOKED LIKE IT WAS BEING PRIMED. A YELLOW TINT WAS NOTICED IN LINE 7. THERE WERE NO CRIMPS OR KINKS SEEN IN THE TRANSFER SET LINES THAT WOULD CAUSE A POSSIBLE BACK UP OF SOLUTION. IT WAS INDICATED PORT 7 MICRO HAD POTASSIUM CHLORIDE COMING DOWN THE LINE AS IF IT WERE BEING PRIMED AND A TINT OF YELLOW MIXED IN. THIS WOULD INDICATE PORT 7 VALVE MAY HAVE BEEN COMPROMISED CAUSING THE POTASSIUM CHLORIDE TO COME DOWN THE LINE AND THE MVI FROM PORT 19 (WHILE BEING PRIMED) TO ENTER THE COMPROMISED VALVE 7 AND MIX WITH THE POTASSIUM CHLORIDE CAUSING A YELLOW TINT IN THE SOLUTION. IT WAS IMMEDIATELY ADVISED TO REPLACE THE TRANSFER SET AND SCRAP THE BAG. NO PATIENT INVOLVEMENT.

    Additional Manufacturer Narrative · 1

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INC. INTERNAL REPORT NUMBER (B)(4). THE DEVICE INVOLVED HAS NOT BEEN RECEIVED FOR EVALUATION AND 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: WHEN INITIALLY PRIMING PORT 7 (POTASSIUM CHLORIDE) OCCLUSIONS WERE RECEIVED. CUSTOMER WAS ABLE TO GET PAST THE OCCLUSIONS AFTER TROUBLESHOOTING AND POWER-CYCLING THE PUMP. UPON PRIMING PORT 19 (ADULT MVI), AND PRIMING VERY SLOW, IT WAS NOTICED THE PORT 7 MICRO SIDE LOOKED LIKE IT WAS BEING PRIMED. A YELLOW TINT WAS NOTICED IN LINE 7. THERE WERE NO CRIMPS OR KINKS SEEN IN THE TRANSFER SET LINES THAT WOULD CAUSE A POSSIBLE BACK UP OF SOLUTION. IT WAS INDICATED PORT 7 MICRO HAD POTASSIUM CHLORIDE COMING DOWN THE LINE AS IF IT WERE BEING PRIMED AND A TINT OF YELLOW MIXED IN. THIS WOULD INDICATE PORT 7 VALVE MAY HAVE BEEN COMPROMISED CAUSING THE POTASSIUM CHLORIDE TO COME DOWN THE LINE AND THE MVI FROM PORT 19 (WHILE BEING PRIMED) TO ENTER THE COMPROMISED VALVE 7 AND MIX WITH THE POTASSIUM CHLORIDE CAUSING A YELLOW TINT IN THE SOLUTION. IT WAS IMMEDIATELY ADVISED TO REPLACE THE TRANSFER SET AND SCRAP THE BAG. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    80340 APEX¿ COMPOUNDER NEP B. BRAUN MEDICAL INC AX1000 04046955048502

    Patients

    Seq Age Sex Outcome Treatment
    1