BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD SERO-FUGE 2002 CENTRIFUGE

    MDR report key: 3159008 · Received June 4, 2013

    Report

    Report Number
    1119779-2013-00006
    Event Type
    Injury
    Date Received
    June 4, 2013
    Date of Event
    May 9, 2013
    Report Date
    May 9, 2013
    Manufacturer
    BD DIAGNOSTIC SYSTEMS
    Product Code
    LXG
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    SERO-FUGE 2002 CENTRIFUGES ARE COMPACT, HIGHLY VERSATILE MACHINES FOR USE IN BLOOD BANKS AND CLINICAL LABS. THEY ARE SPECIFICALLY DESIGNED TO SIMPLIFY MANY BASIC TEST PROCEDURES, SUCH AS BLOOD TYPING, MANUAL CELL WASHING, CROSS-MATCHING, GENOTYPING, COOMBS TESTING AND ANTI-RH TITERS. UNIT FEATURES A LID SAFETY LATCH THAT PERFORMS THE FOLLOWING FUNCTIONS: PREVENTS THE UNIT FROM SPINNING WHILE THE LID IS OPEN; AUTOMATICALLY LOCKS THE LID WHEN THE LID IS CLOSED; PREVENTS LID OPENING UNTIL THE ROTOR HAS STOPPED SPINNING. BD QUALITY INVESTIGATION DETERMINED ROOT CAUSE TO BE THAT THE LID SOLENOID HAD REPEATEDLY COME IN CONTACT WITH THE TACHOMETER WIRES FROM THE MOTOR AND CAUSED ONE WIRE TO BREAK. THE LID IS DESIGNED TO OPEN WHEN THE RPM IS 0 AND WITH THE BROKEN TACHOMETER WIRE THE INSTRUMENT DID NOT REALIZE THE MOTOR WAS SPINNING. THE CENTRIFUGE IS DESIGNED TO REMOVE POWER FROM THE MOTOR WHEN THE LID SOLENOID IS ACTIVATED AND THIS FEATURE WORKED AS DESIGNED. TO IMPROVE ROBUSTNESS OF THE CENTRIFUGE, ENGINEERING WILL UPDATE THE ASSEMBLY INSTRUCTIONS TO HAVE THE WIRES ROUTED AWAY FROM THE LID SOLENOID. ENGINEERING WILL ALSO REVIEW THE MOTOR REPLACEMENT INSTRUCTIONS FOR POSSIBLE IMPROVEMENTS. 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 THEIR SERO-FUGE CENTRIFUGE DOOR WAS OPENING WHILE SPINNING WHEN ANY KEYPAD ENTRY WAS MADE NOT JUST WHEN THE DOOR OPEN OR STOP SWITCH WERE PRESSED IN THE KEYPAD. THE CUSTOMER BIOMED DID NOTE THAT THE UNIT WOULD AUTOMATICALLY CUT POWER TO THE MOTOR WHEN THE DOOR WOULD POP OPEN. UNIT WAS IMMEDIATELY REMOVED FROM USE WHEN ISSUE WAS FOUND. NO INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247586 BD SERO-FUGE 2002 CENTRIFUGE LXG BD DIAGNOSTIC SYSTEMS 420352

    Patients

    Seq Age Sex Outcome Treatment
    1 Other