BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCELERATOR A3600

    MDR report key: 18958703 · Received March 22, 2024

    Report

    Report Number
    3010825766-2024-00002
    Event Type
    Injury
    Date Received
    March 22, 2024
    Date of Event
    February 15, 2024
    Report Date
    March 22, 2024
    Manufacturer
    INPECO SA
    Product Code
    CEM
    UDI-DI
    07640172341001
    PMA / PMN Number
    K121012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    505

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER CONFIRMED THAT THE INJURED LABORATORY OPERATOR HAD FRACTURED A LEFT FINGER. HE/SHE WENT TO E.D. FOR EXAMINATION: X-RAY DONE TO ASSESS THE NATURE OF THE FRACTURE. A FOLLOW-UP VISIT ON X-RAY WAS PLANNED. THE CUSTOMER CONFIRMED THAT THE INJURED LABORATORY TECHNICIAN WAS WEARING PPE (GLOVES AND LAB COAT) AT THE TIME OF INCIDENT. NO BLOOD ANALYSIS PERFORMED AT THE E.D. THE CUSTOMER THEN SPECIFIED THAT, AT THE TIME OF INCIDENT, THE LABORATORY TECHNICIAN WAS ACTUALLY TRYING TO REMOVE A CAP STUCK INSIDE THE ROBOT GRIPPER, NOT THE TUBE AS PREVIOUSLY INDICATED. ACCORDING TO THE LOG ANALYSIS, THERE WAS A TUBE INSIDE THE ROBOT GRIPPER OF THE CENTRIFUGE MODULE (CM). AS THE LABORATORY OPERATOR HAD TO RECOVER THE ERROR, HE / SHE PLACED THE CM OFFLINE, AND GAVE DIAGNOSTIC COMMAND "MOVE TUBE TO DESTINATION/TO SOURCE". HOWEVER, THE OPERATION COULD NOT BE COMPLETED, AND CM RETURNED AGAIN AN ERROR. THEN THE OPERATOR OPENED THE SAFETY SHIELD COVER, AND GAVE THE COMMAND TO OPEN THE GRIPPER. HOWEVER, THE DIAGNOSTIC COMMAND DID NOT WORK, BECAUSE THE MODULE WAS POWERED-OFF, AS THE SAFETY SHIELD COVER WAS OPEN. THE OPERATOR GAVE THE SAME COMMAND 3 MORE TIMES, GETTING THE SAME RESULT. LASTLY, THE OPERATOR PULL THE TUBE, INJURING HIMSELF / HERSELF, SUCCESSFULLY REMOVING THE TUBE FROM THE GRIPPER. ONCE THE CM WAS PLACED BACK ONLINE, IT RETURNED AN ERROR AGAIN. THE INJURY WAS CAUSED BY INCORRECT PROCEDURE FOLLOWED BY THE LABORATORY OPERATOR, THAT SHOULD NOT HAVE MANUALLY REMOVED THE TUBE/CAP. NO DEVICE DEFICIENCIES WERE FOUND. THEREFORE, NO ACTIONS ARE FORESEEN TO BE TAKEN BY THE MANUFACTURER.

    Description of Event or Problem · 0

    THE LABORATORY SUPERVISOR NOTIFIED THE FIELD SERVICE ENGINEER (FSE) ONSITE THAT, ON (B)(6) 2024 AROUND 6:30 PM, ONE OF THE TECHNICIANS HAD HIS FINGER JAMMED INSIDE THE ROBOT GRIPPER FINGERS OF THE CENTRIFUGE MODULE (CM), WHILE ATTEMPTING TO MANUALLY REMOVE A TUBE THAT WAS STUCK INSIDE THE GRIPPER DUE TO A BARCODE LABEL ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2275963 ACCELERATOR A3600 LABORATORY AUTOMATION SYSTEM CEM INPECO SA 07640172341001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other