BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENGEN LABORATORY AUTOMATION SYSTEM

    MDR report key: 2080287 · Received May 6, 2011

    Report

    Report Number
    1319681-2011-00107
    Event Type
    Malfunction
    Date Received
    May 6, 2011
    Date of Event
    April 8, 2011
    Report Date
    May 6, 2011
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT THE CENTRIFUGE MODULE OF THE ENGEN SYSTEM CAME TO A SUDDEN AND COMPLETE STOP. THE ASSIGNABLE CAUSE IS UNKNOWN; HOWEVER, THE MOST LIKELY CAUSE WAS UNOBSERVED MICRO CRACKS IN THE CENTRIFUGE BUCKETS THAT CAUSED THE BUCKETS TO BREAK OFF THE ROTOR SUPPORTS, CAUSING THE CENTRIFUGE TO STOP SUDDENLY AND BECOME DAMAGED. A ROOT CAUSE INVESTIGATION IS ONGOING BY THE CENTRIFUGE MANUFACTURER. FOUR OF THE SIX OPERATORS AFFECTED HAVE BEEN DISCHARGED FROM CARE AND TWO OPERATORS HAVE ADDITIONAL FOLLOW-UP VISITS SCHEDULED. WHILE NO SEVERE OR LONG TERM HEALTH CONSEQUENCES ARE LIKELY, THE POSSIBILITY OF IDIOSYNCRATIC AND POTENTIALLY SEVERE REACTIONS (RESPIRATORY, NEUROLOGICAL, CARDIOVASCULAR) CANNOT BE RULED OUT. AN URGENT PRODUCT CORRECTION NOTIFICATION, (B)(4), WAS SENT TO ALL AFFECTED ENGEN CUSTOMERS ON (B)(4) 2011 FOR ENGEN LABORATORY AUTOMATION SYSTEMS USING HETTICH ROTANTA 46 RSC ROBOTIC CENTRIFUGES, MODELS 4815, 4816 AND 4817. (B)(4).

    Description of Event or Problem · 1

    THIS CUSTOMER REPORTED THAT ONE OF THEIR ENGEN LABORATORY AUTOMATION SYSTEM (LAS) CENTRIFUGES HAD COME TO A SUDDEN, UNEXPECTED STOP, RESULTING IN A LOUD NOISE, CAUSING SIX OPERATORS AT THE CUSTOMER LABORATORY TO SEEK TREATMENT FOR VARIOUS TYPES OF SYMPTOMS INCLUDING RINGING EARS, TINNITUS, HEADACHE, NECK SPRAIN, ORAL ULCERS, TOXIC EFFECTS FROM A RELEASED VAPOR, AND RESPIRATORY EFFECTS SUCH AS CHEST TIGHTNESS. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENGEN LABORATORY AUTOMATION SYSTEM LABORATORY AUTOMATION SYSTEM JJE ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1