BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 9177128 · Received October 10, 2019

    Report

    Report Number
    1119779-2019-00115
    Event Type
    Malfunction
    Date Received
    October 10, 2019
    Date of Event
    September 24, 2019
    Report Date
    February 11, 2020
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    LXG
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION:CUSTOMER REPORTED A BURNING SMELL EMANATING FROM SEROFUGE CENTRIFUGE 3930005. NO FIRE WAS DETECTED IN REGARDS TO THE INSTRUMENT AND NO ONE WAS HARMED. THE INSTRUMENT WAS REPLACED WITH A REPLACEMENT INSTRUMENT. THE CENTRIFUGE WAS RETURNED TO BD AND INVESTIGATED. WITH POWER APPLIED, THE UNIT WOULD START SPINNING WITHOUT A COMMAND BEING GIVEN. THE INSTRUMENT IMMEDIATELY STARTED EMITTING A BURNING SMELL. CONFIRMATION OF A LATCH FAILURE COULD NOT OCCUR DUE TO THE LATCH BEING DISMANTLED BY THE CUSTOMER. THE BURNING SMELL IS A CONFIRMED FAILURE OF THE INSTRUMENT. THE SEROFUGE¿INSTRUMENT HAS BEEN DESIGNED AND MANUFACTURED IN SUCH A WAY AS TO REDUCE, AS FAR AS POSSIBLE, THE RISKS OF FIRE OR EXPLOSION DURING NORMAL USE AND IN SINGLE FAULT CONDITION. IT MEETS THE REQUIREMENTS OF THE FOLLOWING STANDARDS: IEC 61010-1:2001 (ED. 2), UL 61010-1 (ED.2), SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL, AND LABORATORY USE - PART 1 - GENERAL REQUIREMENTS ALL UL TESTING HAS BEEN PERFORMED ON THIS INSTRUMENT PLATFORM AND WAS FOUND TO BE COMPLIANT WITH AFOREMENTIONED INTERNATIONAL REGULATION(S). THE REQUIREMENTS CONTAINED IN THE STANDARD(S) HAVE BEEN SATISFIED: TESTING IN SINGLE FAULT CONDITIONS WHICH COULD CAUSE THE SPREAD OF FIRE OUTSIDE THE INSTRUMENT, ELIMINATION OR REDUCTION OF THE SOURCES OF IGNITION WITHIN THE INSTRUMENT, AND CONTAINMENT OF A FIRE WITHIN THE INSTRUMENT, SHOULD IT OCCUR. THE ROOT CAUSE IS UNDETERMINED AT THIS TIME. ASSIGNABLE CAUSES INCLUDE: SHORTED COMPONENTS ON CIRCUIT BOARD, WORN BRUSHES ON MOTOR, OR LIQUID SPILLS INTO THE INSTRUMENT. DHR REVIEW NOT REQUIRED BECAUSE THIS IS NOT AN ALLEGED ELF (EARLY LIFE FAILURE) OR FAI (FAILURE AT INSTALL). CORRECTIVE ACTION IS NOT REQUIRED AS THE FAILURE MODE IS WITHIN ALLOWABLE LIMITS. BD QUALITY WILL CONTINUE TO CLOSELY MONITOR TRENDS ASSOCIATED WITH THE FAILURE OF SAFETY. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD SERO-FUGE¿ 2001 CENTRIFUGE, 1 SPEED, 115V WAS EMITTING A BURNING SMELL, AND WAS SPINNING WITH THE LID OPEN. THE UNIT HAS TO BE UNPLUGGED IN ORDER TO TURN IT OFF.

    Additional Manufacturer Narrative · 1

    FOR OEM MANUFACTURING SITES: IN THIS MDR, BD DS HEADQUARTERS IN (B)(4) HAS BEEN LISTED AS OEM (B)(4) IS AN OEM MANUFACTURING SITE. A DEVICE EVALUATION IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: BASED ON THE PROVIDED SERIAL NUMBER, THIS DEVICE WAS THE 5TH DEVICE OF THIS CATALOG NUMBER MANUFACTURED IN SEPTEMBER OF THE YEAR 2003.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD SERO-FUGE¿ 2001 CENTRIFUGE, 1 SPEED, 115V WAS EMITTING A BURNING SMELL, AND WAS SPINNING WITH THE LID OPEN. THE UNIT HAS TO BE UNPLUGGED IN ORDER TO TURN IT OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    968562 BD SERO-FUGE¿ 2001 CENTRIFUGE, 1 SPEED, 115V GENERAL PURPOSE LABORATORY CENTRIFUGE LXG BECTON, DICKINSON & CO.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other