BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD KIESTRA READA COMPACT

    MDR report key: 16748648 · Received April 16, 2023

    Report

    Report Number
    3010141591-2023-00002
    Event Type
    Malfunction
    Date Received
    April 16, 2023
    Date of Event
    March 16, 2023
    Report Date
    July 5, 2023
    Manufacturer
    BD KIESTRA LAB AUTOMATION
    Product Code
    JTQ
    UDI-DI
    00382904472061
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6. INVESTIGATION SUMMARY: THE CUSTOMER REPORTED ON THE READA COMPACT MATERIAL NUMBER: (B)(4) SERIAL NUMBER: (B)(6). IT WAS REPORTED BY THE CUSTOMER THAT 3 DISHES THAT HAS MOLD ON IT AND RC3 HAS A LOT OF HUMIDITY AND BAD SMELL. BD TECHNICAL SERVICES RECOMMENDED THAT THE CUSTOMER PERFORM THE REQUIRED MAINTENANCE TO CLEAN THE INCUBATOR. A FIELD SERVICE ENGINEER (FSE) WENT ONSITE AND REPLACED THE HEPA FILTER. AFTER THIS, THE ISSUE HAS BEEN RESOLVED AND NOW THE INSTRUMENT IS BACK TO ROUTINE USE. THE COMPLAINT IS CONFIRMED. NO NEW TRENDS, RISKS, OR HAZARDS WERE IDENTIFIED AS A RESULT OF THIS COMPLAINT. NO PATIENT IMPACT WAS REPORTED AS PART OF THIS COMPLAINT. DEVICE HISTORY RECORD (DHR) REVIEW IS NOT REQUIRED FOR THIS COMPLAINT. THE COMPLAINT WAS EVALUATED VIA OTHER ELEMENTS OF THE INVESTIGATION. THE RESULTS OF THIS EVALUATION HAVE NOT IDENTIFIED ANY NEW HAZARDS, NEW RISKS, OR SPECIFIC TRENDS. BD QUALITY WILL CONTINUE TO CLOSELY MONITOR FOR TRENDS ASSOCIATED WITH THIS ISSUE. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD KIESTRA READA COMPACT THAT THERE WAS CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ¿ DURING THE READING CUSTOMER FOUND THAT THERE IS 3 DISHES THAT HAS MOLD ON IT . ¿ CUSTOMER GAVE THE DISHES NUMBER TO PROCEED TO FIND ALL THE LOCATIONS THAT WERE ON THE RC. ¿ CUSTOMER PROCEED TO DECONTAMINATE ALL THE AREAS WHEN THIS DISHES WERE. ¿ CUSTOMER IS ALSO COMPLAINING THAT THIS RC3 HAS A LOT HUMIDITY AND BAD SMELL. ¿ CUSTOMER IS ASKING FROM COMPLETE CHECK OF THIS RC AND ASKING DECONTAMINATION PROCEDURE. ¿ FOR NOW CUSTOMER WILL CHECK PLATE BY PLATE TO ENSURE THAT THERE IS NO MOLD ON IT. R 2. ISSUE DESCRIPTION: CUSTOMER REPORTS THAT FIND MOLD IN THE RC3 IN 3 DISHES IN RC3.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD KIESTRA READA COMPACT THAT THERE WAS CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING THE READING CUSTOMER FOUND THAT THERE IS 3 DISHES THAT HAS MOLD ON IT. CUSTOMER GAVE THE DISHES NUMBER TO PROCEED TO FIND ALL THE LOCATIONS THAT WERE ON THE RC. CUSTOMER PROCEED TO DECONTAMINATE ALL THE AREAS WHEN THIS DISHES WERE. CUSTOMER IS ALSO COMPLAINING THAT THIS RC3 HAS A LOT HUMIDITY AND BAD SMELL. CUSTOMER IS ASKING FROM COMPLETE CHECK OF THIS RC AND ASKING DECONTAMINATION PROCEDURE. FOR NOW CUSTOMER WILL CHECK PLATE BY PLATE TO ENSURE THAT THERE IS NO MOLD ON IT. ISSUE DESCRIPTION: CUSTOMER REPORTS THAT FIND MOLD IN THE RC3 IN 3 DISHES IN RC3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2259828 BD KIESTRA READA COMPACT NOT CLASSIFIED JTQ BD KIESTRA LAB AUTOMATION 447206 00382904472061

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown