BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERO-FUGE 2001 CENTRIFUGE 1 SPEED WITH 12-PLACE HEAD

    MDR report key: 7017667 · Received November 10, 2017

    Report

    Report Number
    1119779-2017-00008
    Event Type
    Malfunction
    Date Received
    November 10, 2017
    Date of Event
    October 12, 2017
    Report Date
    November 8, 2017
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    LXG
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SERO-FUGE 2001 IS A CENTRIFUGE DESIGNED FOR USE IN BLOOD BANKS AND CLINICAL LABORATORIES. THE OPERATOR'S MANUAL INDICATES THAT TO AVOID PHYSICAL INJURY, THE CUSTOMER SHOULD NOT ATTEMPT TO OPERATE THE CENTRIFUGE WITH THE LID SAFETY LATCH NOT FUNCTIONING PROPERLY NOR OPEN THE CENTRIFUGE LID WHILE THE ROTOR IS SPINNING. BD QUALITY RECEIVED THE CUSTOMER-RETURNED CENTRIFUGE AND OBSERVED THE FOLLOW. THE RETURN SPRING IN THE LID LATCH MECHANISM WAS BROKEN AND PREVENTED THE LID LATCH FROM RETURNING TO ITS OPEN POSITION WHEN THE LID WAS RAISED. THIS EFFECTIVELY KEPT THE LID SWITCH CLOSED AND ALLOWED THE CENTRIFUGE TO SPIN WHILE THE LID WAS IN THE OPEN POSITION. THE RETURN SPRING SHOWED SOME CORROSION WHICH MAY HAVE CONTRIBUTED TO THE BREAKAGE. THERE WAS EVIDENCE OF A SAMPLE SPILL IN OR NEAR THE CENTRIFUGE. IT WAS ALSO OBSERVED THAT THE LATCH HOOK WAS RUBBING AGAINST THE LATCH BRACKET CAUSING A DEEP GROOVE IN THE LATCH HOUSING. THIS MAY HAVE BEEN DUE TO A MISALIGNED LID HINGE WHICH HAD EVIDENCE OF BEING REPAIRED AND/OR ADJUSTED BY THE CUSTOMER SITE. PER THE SEROFUGE USER MANUAL PAGE 22 UNDER THE HEADING OF TO AVOID PHYSICAL INJURY STATES: ¿ NEVER ATTEMPT TO OPERATE THE CENTRIFUGE WITH THE LID SAFETY LATCH NOT FUNCTIONING PROPERLY. ¿ NEVER ATTEMPT TO OPEN THE CENTRIFUGE LID WHILE THE ROTOR IS SPINNING. ¿ TEST LID SEAL INTEGRITY BY INSERTING A .005¿ FEELER GAUGE BETWEEN THE OPEN LID AND BOWL GASKET. WITH THE LID CLOSED AND LATCHED A SLIGHT DRAG OR RESISTANCE SHOULD BE FELT WHEN PULLING THE FEELER GAUGE FROM LAST THE LID. THIS TEST SHOULD BE PERFORMED ALONG THE ENTIRE PERIMETER OF THE LID TO ENSURE A TIGHT LID SEAL. QUALITY WILL CONTINUE TO MONITOR TRENDS AND DETERMINE APPROPRIATE ACTIONS AS NEEDED. DEVICE EVALUATED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SERO-FUGE 2001 CENTRIFUGE CONTINUES TO SPIN AFTER THE LID OPENS. THE UNIT WAS TAKEN OUT OF SERVICE AND REPLACED. NO INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    802520 SERO-FUGE 2001 CENTRIFUGE 1 SPEED WITH 12-PLACE HEAD SERO-FUGE¿ 2001 CENTRIFUGE LXG BECTON, DICKINSON & CO.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other