BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    J.L. SHEPHERD BLOOD IRRADIATOR

    MDR report key: 1436254 · Received August 6, 2009

    Report

    Report Number
    MW5012322
    Event Type
    Malfunction
    Date Received
    August 6, 2009
    Date of Event
    August 6, 2009
    Report Date
    August 6, 2009
    Manufacturer
    J.L. SHEPHERD & ASSOCIATES
    Product Code
    MOT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE J.L. SHEPHERD BLOOD IRRADIATOR IS UTILIZED TO IRRADIATE BLOOD AND BLOOD PRODUCTS. IN ORDER TO PROVIDE UNIFORM EXPOSURE TO THE IRRADIATION SOURCE AND THUS ENSURE A PREDICTABLE DOSE, THE CANISTER CONTAINING THE BLOOD UNIT-S ROTATES DURING THE IRRADIATION CYCLE. ROTATION IS CONFIRMED BY A LIGHT ON THE DEVICE INSTRUMENT PANEL. THIS SINGLE VISUAL REFERENCE IS THE ONLY INDICATION THAT THE CANISTER IS ROTATING. THERE IS NO ALARM THAT DESIGNATES FAILURE MODE AND THE DEVICE HAS NO COMPUTER/SOFTWARE INTERFACE TO RECORD AND MONITOR DEVICE OUTPUT OR FLAG A MECHANICAL FAILURE OF ANY NATURE. THIS COMPELS USERS TO MANUALLY RECORD ALL ACTIVITY AND ASSURES THAT INTERMITTENT FAILURES I.E., INITIAL ROTATION FOLLOWED BY ONE OR MORE FAILURES DURING A CYCLE - MAY NOT BE NOTICED BY A USER WHO HAS NOT BEEN ABLE TO OBSERVE THE LIGHT CONTINUOUSLY DURING OPERATION. FAILURE TO PROPERLY IRRADIATE A BLOOD COMPONENT MAY HAVE SERIOUS CONSEQUENCES FOR PATIENTS WHO REQUIRE THIS TYPE OF BLOOD PRODUCT. THE MANUFACTURER SHOULD UPGRADE ALL DEVICES TO PROVIDE AT LEAST AN AUDIBLE ALARM OR COMPUTER GENERATED MESSAGE/ALERT TO DESIGNATE SERIOUS MECHANICAL FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 J.L. SHEPHERD BLOOD IRRADIATOR BLOOD IRRADIATOR MOT J.L. SHEPHERD & ASSOCIATES 143-68A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other