BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREPSTAIN SYSTEM

    MDR report key: 1638273 · Received March 16, 2010

    Report

    Report Number
    1062336-2010-00004
    Event Type
    Malfunction
    Date Received
    March 16, 2010
    Date of Event
    February 17, 2010
    Manufacturer
    ANDREAS HETTICH GMBH & CO.
    Product Code
    MKQ
    PMA / PMN Number
    P970018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON MARCH 4, 2010, (B)(6), NOTIFIED BD TRIPATH OF A FIELD ACTION REGARDING THE ROTINA 380 MODELS. ON THE LID OF THE CENTRIFUGE THERE ARE TWO "GAS SPRINGS" THAT ASSIST THE LID TO BE RAISED AND PREVENT IT FROM FALLING WHEN RELEASED. THE SPRINGS ARE ATTACHED TO THE LID AT ONE END AND TO A BRACKET INSIDE THE CENTRIFUGE HOUSING AT THE OTHER. THE CENTRIFUGE WAS RECEIVED ON MARCH 9, 2010. QA ENGINEERING AND OPERATIONS EVALUATED THE RETURNED CENTRIFUGE AND CONFIRMED THE FIELD ACTION (RECALL/RETROFIT) DEFECT CITED BY (B)(6). BOTH GAS STRUTS WERE DETACHED, HOWEVER, THE LEFT REAR STRUT APPARENTLY HAD TOUCHED THE POWER TRANSFORMER CAUSING AN ELECTRICAL SHORTAGE, BECAUSE ELECTRICAL BURNS COULD BEEN SEEN ON THE STRUT AND TRANSFORMER. ALSO, THE INSTRUMENT WOULD NOT POWER-UP, THEREFORE, NO OTHER PARAMETERS COULD BE EVALUATED. (B)(6) HAS INITIATED AN INVESTIGATION TO DETERMINE THE ROOT CAUSE AND APPROPRIATE CORRECTIVE ACTIONS. IN ADDITION, (B)(6) IS FACILITATING ALL ACTIVITIES ASSOCIATED WITH THEIR FIELD ACTION. BD DIAGNOSTICS HAS PROVIDED THE LOCATIONS AND CUSTOMERS FOR THE AFFECTED INSTRUMENTS.

    Description of Event or Problem · 1

    THE CYTOPATHOLOGY LABORATORY OBSERVED THAT ONE OF THE SHOCKS WAS DAMAGED ON THE CENTRIFUGE. THE LID WILL NOT STAY UP. IN ADDITION, THERE WAS A BURNING SMELL COMING FROM THE CENTRIFUGE SO THEY DISCONNECTED THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PREPSTAIN SYSTEM HETTICH CENTRIFUGE (COMPONENT) MKQ ANDREAS HETTICH GMBH & CO. ROTINA 380 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK