BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SERO-FUGE¿ 2001 CENTRIFUGE, 1 SPEED, 115V

    MDR report key: 7954282 · Received October 10, 2018

    Report

    Report Number
    1119779-2018-00013
    Event Type
    Malfunction
    Date Received
    October 10, 2018
    Date of Event
    September 21, 2018
    Report Date
    January 7, 2019
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    LXG
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: A COMPLAINT OF A SERO-FUGE 2001 CENTRIFUGE (S/N 4240018, MANUFACTURED IN APRIL 2006) SPINNING WITH THE LID OPEN IS CONFIRMED. THE CUSTOMER REPORTED THAT THE UNIT WAS SPINNING SPONTANEOUSLY WHEN PLUGGED IN AND SPINNING WITH THE LID OPEN. THE UNIT WAS RECEIVED AND INVESTIGATED AND FOUND THAT THE PRINTED CIRCUIT BOARD ASSEMBLY HAD A SHORTED MOTOR TRIAC, CAUSING THE CENTRIFUGE TO SPIN WHEN PLUGGED INTO THE AC OUTLET REGARDLESS OF THE LID CONDITION (OPEN OR CLOSED). IT WAS OBSERVED THAT THIS CENTRIFUGE WAS HEAVILY USED AND HAD SIGNS OF LIQUID SPILLS WHICH COULD HAVE CONTRIBUTED TO THE MOTOR TRIAC FAILURE. THE CUSTOMER WAS SHIPPED A REPLACEMENT UNIT. NO FURTHER ACTION IS REQUIRED. BD INSTRUMENT PLANT WILL CONTINUE TO MONITOR FOR TRENDS ASSOCIATED WITH THIS DEFECT. INVESTIGATION CONCLUSION: THE COMPLAINT OF A SERO-FUGE 2001 CENTRIFUGE SPINNING WITH THE LID OPEN IS CONFIRMED. THE SERVICE HISTORY WAS REVIEWED FOR THIS INSTRUMENT AND NO ISSUES WERE IDENTIFIED. HAZARD ANALYSIS: THIS ISSUE IS LISTED AS AN S4, ¿SEVERE INJURY TO OPERATORS HAND, EXPOSURE TO BIOHAZARDS¿. ROOT CAUSE DESCRIPTION: THE CAUSE WAS A SHORTED MOTOR TRIAC. RATIONALE: THERE IS CURRENTLY A CAPA (B)(4) LOOKING AT THE RELIABILITY OF THE LATCH MECHANISM ON SERO-FUGE SERIES CENTRIFUGES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BD SERO-FUGE¿ 2001 CENTRIFUGE, 1 SPEED, 115V WAS SPINNING WITH THE LID OPEN.

    Additional Manufacturer Narrative · 1

    (B)(4). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. BASED ON THE PROVIDED SERIAL NUMBER, THIS DEVICE WAS THE 18TH DEVICE WITH THIS CATALOG NUMBER MANUFACTURED IN DEC. 2005.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BD SERO-FUGE¿ 2001 CENTRIFUGE, 1 SPEED, 115V WAS SPINNING WITH THE LID OPEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    792947 BD SERO-FUGE¿ 2001 CENTRIFUGE, 1 SPEED, 115V EQUIPMENT, LABORATORY, GENERAL PURPOSE LXG BECTON, DICKINSON & CO.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other