BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SEDI-40

    MDR report key: 7592025 · Received June 12, 2018

    Report

    Report Number
    2243072-2018-01230
    Event Type
    Malfunction
    Date Received
    June 12, 2018
    Date of Event
    November 20, 2017
    Report Date
    May 21, 2018
    Manufacturer
    BECTON DICKINSON
    Product Code
    GHC
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IN THIS MDR, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AS (B)(4) IS AN OEM MANUFACTURING SITE. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. DATE DEVICE RETURNED TO MANUFACTURER IS UNKNOWN. INVESTIGATION SUMMARY: THE CUSTOMER'S INSTRUMENT WAS RETURNED TO THE MANUFACTURER FOR SERVICE. THE INSTRUMENT WAS EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR LLO AND LHI FLAGGING WAS NOT OBSERVED. EVALUATION OF THE CUSTOMER UNIT WAS PERFORMED AND THE INDICATED FAILURE MODE COULD NOT BE REPLICATED. INVESTIGATION CONCLUSION: BASED ON EVALUATION OF THE CUSTOMER'S INSTRUMENT, THE CUSTOMER¿S INDICATED FAILURE MODE FOR LLO AND LHI FLAGGING WITH THE UNIT WAS NOT OBSERVED. ROOT CAUSE DESCRIPTION: BASED ON THE INVESTIGATION, A ROOT CAUSE COULD NOT BE DETERMINED. THE PRODUCT WAS FOUND TO BE IN CONFORMANCE AND MEET RELEASE SPECIFICATIONS. RATIONALE: 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 · 1

    IT WAS REPORTED THAT BD SEDI-40 GIVES A LOT OF LLO AND LHI MESSAGES. NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    436093 BD SEDI-40 ESR INSTRUMENT GHC BECTON DICKINSON SN 00219

    Patients

    Seq Age Sex Outcome Treatment
    1 Other