BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD TOTALYS SLIDEPREP

    MDR report key: 21496327 · Received February 28, 2025

    Report

    Report Number
    1119779-2025-00141
    Event Type
    Malfunction
    Date Received
    February 28, 2025
    Date of Event
    January 30, 2025
    Report Date
    March 13, 2025
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    MKQ
    PMA / PMN Number
    P970018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED INFORMATION: B5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED WHEN USING THE BD TOTALYS SLIDEPREP, THERE WAS A PROBLEM WITH THE HINGES ON THE CENTRIFUGE HETTICH 380 220V WHICH DID NOT ALLOW THE LID TO CLOSE PROPERLY. THE LID WAS FREE-FALLING AND/OR DID NOT STAY OPEN DUE TO THIS ISSUE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER. D1. MEDICAL DEVICE BRAND NAME: BD TOTALYS SLIDEPREP. D2A. COMMON DEVICE NAME: PROCESSOR, CERVICAL CYTOLOGY SLIDE, AUTOMATED. D2B. MEDICAL DEVICE TYPE: MKQ. D4. MEDICAL DEVICE CATALOG #: 491346. D4. UNIQUE IDENTIFIER (UDI) #: (B)(4). D4. MEDICAL DEVICE SERIAL #: (B)(6). G4. PMA / 510(K)#: P970018. H4. DEVICE MANUFACTURE DATE: 20-JAN-2021. INVESTIGATION SUMMARY: THE COMPLAINT ALLEGES CENTRIFUGE HINGES NOT WORKING AND WON'T CLOSE (CATALOG NUMBER 491346, SERIAL NUMBER (B)(6). SERVICE HAD REPLACED HETTICH 380 CENTRIFUGE AND TESTED. THE DEVICE IS NOW TECHNICALLY EFFICIENT ACCORDING TO MANUFACTURER DOCUMENTATION. BASED ON SERVICE INVESTIGATION, THE COMPLAINT IS CONFIRMED AND THE ROOT CAUSE IS ATTRIBUTED TO FAULTY CENTRIFUGE. REVIEW OF DEVICE HISTORY RECORD FOR INSTRUMENT SERIAL NUMBER, (B)(6) IS NOT REQUIRED BECAUSE THIS COMPLAINT DOES NOT ALLEGE AN EARLY LIFE FAILURE OR FAILURE AT INSTALLATION AND HAS CHANGED CONFIGURATION SINCE RELEASE FROM MANUFACTURING DUE TO SERVICE REPAIRS/PMS. SERVICE HISTORY REVIEW REVEALED NO COMPLAINT FOR SIMILAR ROOT CAUSE ATTRIBUTES. SAMPLES WERE NOT RECEIVED BY QUALITY FOR INVESTIGATION AND THUS, RETURNED MATERIAL INVESTIGATION COULD NOT OCCUR. NO NEW TRENDS, RISKS, OR HAZARDS WERE IDENTIFIED AS A RESULT OF THE COMPLAINT. BD QUALITY WILL CONTINUE TO CLOSELY MONITOR FOR TRENDS ASSOCIATED WITH THIS COMPLAINT.

    Additional Manufacturer Narrative · 0

    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 WHEN USING THE BD TOTALYS SLIDEPREP, THERE WAS A PROBLEM WITH THE HINGES ON THE CENTRIFUGE HETTICH 380 220V WHICH DID NOT ALLOW THE LID TO CLOSE PROPERLY. THE LID WAS FREE-FALLING AND/OR DID NOT STAY OPEN DUE TO THIS ISSUE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Description of Event or Problem · 0

    IT WAS REPORTED PRIOR TO USING CENTRIFUGE HETTICH 380 220V, THERE WAS A PROBLEM WITH THE HINGES THAT WOULD NOT CLOSE THE CENTRIFUGE LID. THE LID WAS FREE-FALLING AND/OR DID NOT STAY OPEN DUE TO THIS ISSUE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611738 BD TOTALYS SLIDEPREP PROCESSOR, CERVICAL CYTOLOGY SLIDE, AUTOMATED MKQ BECTON DICKINSON & CO. (SPARKS)

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown