BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD SERO-FUGE 2001 CENTRIFUGE

    MDR report key: 3138048 · Received May 22, 2013

    Report

    Report Number
    1119779-2013-00005
    Event Type
    Injury
    Date Received
    May 22, 2013
    Date of Event
    April 23, 2013
    Report Date
    April 23, 2013
    Manufacturer
    BD DIAGNOSTIC SYSTEMS
    Product Code
    LXG
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    BD'S RECOMMENDED LIDSEAL MAINTENANCE INCLUDES THE FOLLOWING: A VISUAL INSPECTION OF THE LIDSEAL SHOULD BE PERFORMED BEFORE EACH USE. THE LIDSEAL SHOULD BE REPLACED IF ANY TEARS OR OTHER DEGRADATION IS NOTED BEFORE USE. IT IS NECESSARY TO VERIFY THE INTEGRITY OF THE SEAL BETWEEN THE LIDSEAL AND BOWL GASKET: EACH TIME THE UNIT IS SERVICED OR REPAIRED; DURING EACH PREVENTIVE MAINTENANCE; ANYTIME A PROBLEM WITH THE SEAL IS SUSPECTED; EVERY THREE MONTHS, WHICHEVER OCCURS FIRST. THE CENTRIFUGE WAS NOT RETURNED TO BD FOR EVALUATION. THE CUSTOMER INSPECTED THE LIDSEAL WHICH SHOWED EVIDENCE OF WEAR AND TEAR. THE CUSTOMER NOTED THAT THE BLOOD SEEMED TO EXIT THROUGH THE AREAS WHERE THE SEAL WAS DAMAGED. THE CUSTOMER REQUESTED A NEW SEAL AND ROTOR IN ORDER TO REPAIR AND TO PLACE THE CENTRIFUGE BACK INTO SVC IN THE LAB. ROOT CAUSE OF FLUID EXPULSION HAS BEEN ATTRIBUTED AND CONFIRMED BY THE CUSTOMER AS A WORN AND DAMAGED LIDSEAL. IT IS UNCLEAR HOW THE CUSTOMER WAS MAINTAINING THE EQUIPMENT. BD PROVIDED THE CUSTOMER WITH THE PROPER SVC REQUIREMENTS AND SPARE PARTS. ROOT CAUSE OF ROTOR FAILURE WAS ATTRIBUTED TO THE ADHESIVE USED TO MANUFACTURE THE ROTOR AND WAS ADDRESSED IN A CORRECTIVE ACTION DATED (B)(4) 2005. THE ROTOR ON THIS UNIT WAS THE ORIGINAL ROTOR AND WAS MADE PRIOR TO THE IMPLEMENTATION OF THIS CORRECTIVE ACTION. A PROPERLY MAINTAINED LID AND LIDSEAL WOULD EFFECTIVELY CONTAIN ANY BREAKAGE OR FLUID DURING THIS TYPE OF EVENT. COMPLAINT TRENDING WAS PERFORMED. THERE IS NO TREND ON THIS TYPE OF DEFECT NOTED. NO FURTHER ACTION WILL BE TAKEN AT THIS TIME AS THIS APPEARS TO BE AN ISOLATED EVENT. BD WILL CONTINUE TO TREND ON THIS TYPE OF EVENT.

    Description of Event or Problem · 1

    CUSTOMER NOTED THAT THE 12 PLACE PLASTIC ROTOR ON THE CENTRIFUGE CAME APART WHILE SPINNING AND BLOOD/SAMPLE WAS NOT CONTAINED WITHIN THE UNIT. NO INJURY OCCURRED. BD SERO-FUGE 2001 CENTRIFUGE IS COMPACT, HIGHLY VERSATILE MACHINE FOR USE IN BLOOD BANKS AND CLINICAL LABORATORIES. IT IS SPECIFICALLY DESIGNED TO SIMPLIFY MANY BASIC TEST PROCEDURES, SUCH AS BLOOD TYPING, MANUAL CELL MACHINING, CROSS MATCHING, GENOTYPING, COOMBS TEST, ANTI-RH TITERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    226684 BD SERO-FUGE 2001 CENTRIFUGE LXG BD DIAGNOSTIC SYSTEMS 420351

    Patients

    Seq Age Sex Outcome Treatment
    1 Other