BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFETEC ELITE V1.0

    MDR report key: 2627095 · Received June 21, 2012

    Report

    Report Number
    2435501-2012-00001
    Event Type
    Malfunction
    Date Received
    June 21, 2012
    Date of Event
    May 7, 2012
    Report Date
    June 20, 2012
    Manufacturer
    IT SYNERGISTICS, LLC.
    Product Code
    MMH
    PMA / PMN Number
    BK060032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE DATE OF THIS REPORT EXCEEDS THE 30-DAY REPORTING PERIOD FOR A MFR IN REFERENCE TO 803.50 SUBPART E, THE INITIAL EVAL OF THE ERROR WOULD NOT CONTRIBUTE TO DEATH OR SERIOUS INJURY. THIS REPORT IS IN RESPONSE TO THE INITIAL ERROR AND INVESTIGATION REPORTED BY THE BLOOD CONNECTION. CORRECTIVE ACTION: AN INVESTIGATION INTO THE MTP HOLD ROUTINE WAS COMPLETED BY IT SYNERGISTICS AND THE DEFECT WAS IDENTIFIED. A CORRECTION WAS NEEDED TO A SQL STORED PROCEDURE TO PREVENT THE ISSUE FROM RE-OCCURRING. THE SOFTWARE PATCH HAS BEEN TESTED SUCCESSFULLY INTERNALLY AND FOUND NO ERROR OR ANOMALIES DURING TESTING, AND SUBSEQUENTLY WAS RELEASED ON (B)(4) 2012 TO ALL FACILITIES.

    Description of Event or Problem · 1

    A MAXIMUM TIME TO PREPARATION (MTP) HOLD WAS NOT APPLIED TO AN ORIGINAL APHERESIS PRODUCT WHEN THE "USE MFG PREP TIME" OPTION WAS ENABLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFETEC ELITE V1.0 LIFETEC ELITE V1.0 MMH IT SYNERGISTICS, LLC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1