BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMAG®

    MDR report key: 7549621 · Received May 29, 2018

    Report

    Report Number
    3002769706-2018-00071
    Event Type
    Malfunction
    Date Received
    May 29, 2018
    Report Date
    October 16, 2018
    Manufacturer
    BIOMERIEUX ITALIA S.P.A.
    Product Code
    JJH
    UDI-DI
    03573026471859
    PMA / PMN Number
    C1 EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    BIOMÉRIEUX CONDUCTED AN INTERNAL INVESTIGATION: THREE (3) HYPOTHESES WERE TESTED TO CHECK IF THEY CAN LEAD TO A LEAKAGE/DRIPPING AND ALARM CODE 10076: 1. CLOG OF ASPIRATOR: TESTING WAS PERFORMED WITH DIRTY SAMPLES THAT COULD CREATE A COMPLETE CLOG OF THE ASPIRATOR DISPOSABLE. 2. DEFECT ON CONSUMABLE: TO MIMIC A DEFECTIVE ASPIRATOR DISPOSABLE, SOME ASPIRATORS WERE DAMAGED, MANY HOLES OF 1MM DIAMETER HAVE BEEN DRILLED IN DIFFERENT STRATEGICAL PLACES TO STUDY THE IMPACT OF AIR LEAKAGE. THE GOAL WAS TO DETERMINE IF IT'S POSSIBLE TO HAVE A FAILED ASPIRATION FOLLOWED BY DRIPPING. 3. WRONG INSERTION OF ASPIRATOR: TESTING WAS PERFORMED WITH ASPIRATOR DISPOSABLE WRONGLY INSERTED AND NOT PROPERLY CONNECTED TO THE ASPIRATION NOZZLE. THE INVESTIGATION WAS COMPLETED IN SEVERAL STEPS AS FOLLOWS: TESTS WERE PERFORMED USING NON-HOMOGENEOUS AND VISCOUS SAMPLES. THE RESULTS: SOME CLOGS WERE OBSERVED BUT NEVER A FULL ASPIRATOR CLOGGING. THE PROBABILITY OF A CLOG LEADING TO FULL VESSEL ABORTION WAS DISCARDED. CUSTOMER CONSUMABLES WERE REQUESTED TO BE TESTED. SMALL DEFECTS WERE OBSERVED ON THE LOCATION OF THE CONTACT WITH THE SEAL OF THE ASPIRATION NOZZLE. NEVERTHELESS, TESTING PERFORMED ON DISPOSABLES REPRODUCED IDENTICAL DEFECTS AND DID NOT SHOW ANY LEAKAGE OR OTHER IMPACT. THE SYSTEM ASPIRATES WITH AN ASPIRATION LEVEL SUFFICIENT TO COMPENSATE THE AIR LEAKAGE CREATED WITH THE DRILLED HOLES. WHATEVER THE LOCATION THE HOLES WERE DRILLED, NO INVALIDATION OF A FULL VESSEL WAS OBSERVED. WHEN ASPIRATOR DISPOSABLES ARE WRONGLY INSERTED, IT LEADS TO FULL VESSEL ABORTION. THE FIRST ASPIRATION COULD NOT BE PERFORMED SO IT TRIGGER AN ALARM 10076 ASSOCIATED TO THE TOO HIGH LIQUID LEVEL DETECTED IN THE VESSEL AFTER THE ASPIRATION. FURTHERMORE, LEAKAGE CAN BE OBSERVED IN CASE OF ASPIRATOR WRONGLY INSERTED BECAUSE THE RUN WILL CONTINUE FOR THE TWO OTHER VESSELS (NO INVALIDATED) AND THE ASPIRATOR TIPS ARE IMMERSED IN THE NO ASPIRATED VOLUME AND THE LIQUID WILL GO IN THE TIPS BY CAPILLARITY AND THEN WILL TRICKLE WHEN THE ASPIRATION BLOCK WILL GO UP. THIS COULD LEAD TO LIQUID SPILLAGE ON THE DISPENSE NEEDLE WHEN THE NEEDLE GO UNDER THE ASPIRATOR THAT ARE DRIPPING. THE ERROR CODE DOES NOT ALERT THE USER THAT, IF AN ASPIRATION ISSUE HAS BEEN DETECTED, DEPENDING ON THE ROOT CAUSE OF THE ASPIRATION ERROR, THE DISPENSING TIPS COULD EXPERIENCE LEAKAGE AND/OR SPECIMEN VESSEL OVERFLOW CAUSING SYSTEM/SAMPLE CROSS CONTAMINATION AND THESE EVENTS COULD LEAD TO THE PRESENCE OF CRYSTALS ON DISPENSING NEEDLES AND USS SENSOR. TO CONCLUDE, THE INVESTIGATION SHOWS THAT TRACES OF SAMPLES AND CRYSTALLIZATION ON DISTRIBUTION NOZZLES WERE REPRODUCED WHEN THE ASPIRATOR DISPOSABLE WAS WRONGLY INSERTED ON THE ASPIRATION NOZZLE. IN THIS CASE DURING THE FIRST ASPIRATION STEPS THE VESSEL IS INVALIDATED BY ERROR 10076 AND THE TIPS ARE FILLED BY CAPILLARITY WITH SAMPLES LYSED PRESENT IN THE INVALIDATED VESSEL. WHEN THE ASPIRATION SUBSYSTEM GOES UP AND THE DISPENSE SUBSYSTEM CHECKS IF THE ASPIRATION HAVE BEEN DONE THE DROPLETS CAN FALL DOWN ON IT. ROOT CAUSE CONCLUDED TO BE INCORRECT INSERTION OF ASPIRATORS; OPERATOR ERROR.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) PREVIOUSLY REPORTED THAT THEY HAD THE PRESENCE OF CRYSTALLIZATION ON THE DISTRIBUTION NOZZLES OF THE EMAG® INSTRUMENT (REF (B)(4)). THE CUSTOMER REPORTED THAT THERE WERE BLOOD CRYSTALS ON THIS NOZZLE RESULTING IN POTENTIAL SPECIMEN CONTAMINATION. AFTER PERFORMING THE CLEANING AS DESCRIBED BY THE USER MANUAL, A PERIOD OF TIME HAD PASSED AND THE SAME ISSUE WAS REPORTED AGAIN. THIS TIME THE CUSTOMER OBSERVED ONE ASPIRATOR THAT WAS SUNK ON THE DISTRIBUTION NOZZLES OF THE EMAG® INSTRUMENT, AND DROPS OF BUFFER/ELUATE WERE OBSERVED ON THE VESSEL CAPS AT THE END OF A RUN. THE CUSTOMER STATED THERE WAS NO INSTRUMENT ERROR BUT THEY COULD NOT DISPENSE SAMPLES BECAUSE THEY DID NOT HAVE ENOUGH ELUATE VOLUME FOR FOUR PARAMETERS. IT WAS NOT KNOWN IF TESTING WAS REPEATED ON THE IMPACTED SAMPLES. THERE IS NO INDICATION OR REPORT FROM THE HOSPITAL OR TREATING PHYSICIAN TO BIOMÉRIEUX THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. THE FIELD SERVICE ENGINEER (FSE) REPLACED THE DISPENSING NEEDLES, AND THE ELUTIONS WERE PERFORMED CORRECTLY. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391916 EMAG® EMAG® JJH BIOMERIEUX ITALIA S.P.A. 418591 03573026471859

    Patients

    Seq Age Sex Outcome Treatment
    1