BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SEDI-40¿

    MDR report key: 7889142 · Received September 19, 2018

    Report

    Report Number
    2243072-2018-01303
    Event Type
    Malfunction
    Date Received
    September 19, 2018
    Date of Event
    August 24, 2018
    Report Date
    October 22, 2018
    Manufacturer
    BECTON DICKINSON
    Product Code
    JKA
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD HAD PERFORMED A TECHNICAL EVALUATION OF THE CUSTOMER'S SEDI-40 INSTRUMENT. IT WAS DETERMINED THAT A MIXING FAULT (LOOSE BELT SPROCKET ON MIXING TUBE HOLDER) WAS CAUSING THE LLO FLAG AND THE INSTRUMENT WAS SUBSEQUENTLY REPAIRED. UPON COMPLETION OF THE SERVICE, THE INSTRUMENT WAS VERIFIED TO BE OPERATING WITHIN THE CORRECT PARAMETERS. THE BATCH NUMBER WAS NOT FOUND IN OUR DATABASE, NO DHR COULD BE PERFORMED. BASED ON EVALUATION OF THE CUSTOMER'S INSTRUMENT, THE LLO FLAG WAS DUE TO A MIXING FAULT AND THE INSTRUMENT WAS REPAIRED. THE ROOT CAUSE WAS ATTRIBUTED TO LOOSE BELT SPROCKET ON THE MIXING TUBE HOLDER. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. THE BD BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SEDI-40¿ BARCODE READER GAVE AN ERROR MESSAGE. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). 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 · 1

    IT WAS REPORTED THAT THE BD SEDI-40¿ BARCODE READER GAVE AN ERROR MESSAGE. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    729245 BD SEDI-40¿ ESR INSTRUMENT JKA BECTON DICKINSON N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other