BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIMA¿ MAX-XP TABLETOP ULTRACENTRIFUGE

    MDR report key: 2480769 · Received March 6, 2012

    Report

    Report Number
    2050012-2012-00526
    Event Type
    Malfunction
    Date Received
    March 6, 2012
    Date of Event
    February 7, 2012
    Report Date
    February 7, 2012
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JQC
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SOLUTIONS TO BOTH ISSUES ARE UNDERSTOOD: FOR THE FIRST ISSUE A DOOR LOCK-OUT OF LONGER DURATION WILL BE APPLIED. FOR THE SECOND PROBLEM APPLYING A DOOR LOCK-OUT WILL BE IMPLEMENTED. TO PREVENT NUISANCE DOOR LOCK-OUTS OF EXTENSIVE DURATION A SHORTER DOOR LOCK-OUT IS EXPECTED TO BE IMPLEMENTED. TO DATE NO FIELD REPORTS OF CUSTOMERS BEING ABLE TO ACCESS A SPINNING ROTOR SINCE THE PRODUCT WAS LAUNCHED. (B)(4).

    Description of Event or Problem · 1

    DURING IN-HOUSE TESTING OF AN OPTIMA MAX-XP INSTRUMENT IT WAS DISCOVERED THAT THE COAST DOWN TIME FROM RATED SPEED FOR SOME ROTORS EXCEEDED THE 60 MINUTE LOCK-OUT TIME. THE INSTRUMENT IS CSA CERTIFIED FOR CLASS 8721 05 AND 8721 85. NO DEATH OR INJURY ASSOCIATED WITH THIS EVENT, THE OPERATOR DID NOT SEEK MEDICAL ATTENTION. TO MEET PRODUCT COMPLIANCE SAFETY REQUIREMENTS THE MAXIMUM SURFACE SPEED OF THE ROTOR WITH THE DOOR OPENED CANNOT EXCEED A ROTOR SURFACE SPEED OF 2 METERS/SEC. FOR THE LARGEST COMPATIBLE ROTOR, THE MLA-50 (.56 M CIRCUMFERENCE), THIS IS EQUIVALENT TO LESS THAN 215 RPM. THE DOOR LOCK-OUT IS APPLIED TO SELECT DIAGNOSTICS TO PROTECT THE USER FROM VENTING THE VACUUM AND OPENING THE DOOR WHEN THE ROTOR IS STILL SPINNING. THERE ARE A TOTAL OF 6 DIAGNOSTIC CONDITIONS WHERE THE DOOR LOCK-OUT IS APPLIED. A NUMBER OF THESE INVOLVE THE TACHOMETER SIGNAL. IF DURING INITIAL START-UP THERE IS NO TACHOMETER SIGNAL THE DRIVE WILL CONTINUE RUNNING UP TO A LOW SPEED (APPROX 600 RPM) BEFORE A NO TACH SPD301 DIAGNOSTIC IS ISSUED. BECAUSE THE TACH SIGNAL IS USED TO REPORT THE ACTUAL SPEED, THE SPEED WILL BE REPORTED AS 0 RPM EVEN THOUGH THE MOTOR AND ROTOR ARE SPINNING. IF BEFORE THE DIAGNOSTIC IS ISSUED THE USER PRESSES STOP THEY CAN VENT THE VACUUM AND OPEN THE CHAMBER DOOR TO ACCESS THE ROTOR WHILE IT IS STILL SPINNING. THE IEC REQUIREMENT ONLY ALLOWS FOR A MAXIMUM ROTOR SURFACE SPEED OF 2 METERS/SECOND. FOR SOME ROTORS AND RUN PARAMETERS IT HAS BEEN SHOWN THE ROTOR SPEED IS EXCEEDING THE REQUIREMENT. IN THE EVENT THE DIAGNOSTIC IS ISSUED AND CLEARED THE USER CAN AGAIN VENT THE VACUUM AND ACCESS THE CHAMBER DOOR WHILE THE ROTOR IS STILL SPINNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTIMA¿ MAX-XP TABLETOP ULTRACENTRIFUGE CENTRIFUGES (MICRO, ULTRA, REFRIGERATED) FOR CLINICAL USE JQC BECKMAN COULTER INC. OPTIMA¿ MAX-XP U CENT. N/A

    Patients

    Seq Age Sex Outcome Treatment
    1