BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRIMA ACCEL AUTO RBC AND PLS SET

    MDR report key: 2120486 · Received May 27, 2011

    Report

    Report Number
    1722028-2011-00137
    Event Type
    Other
    Date Received
    May 27, 2011
    Date of Event
    December 8, 2010
    Report Date
    May 2, 2011
    Manufacturer
    CARIDIANBCT
    Product Code
    LKN
    PMA / PMN Number
    BK100032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION EVAL AND CORRECTIVE ACTIONS ARE IN-PROCESS. A FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    TWO RBC PRODUCT SAMPLES AT DAY-42 HAD HEMOLYSIS THAT EXCEEDED THE (B)(6) REQUIREMENT OF LESS THAN OR EQUAL TO (B)(4). DISPOSABLE SETS ARE NOT AVAILABLE TO BE RETURNED FOR INVESTIGATION. THIS INCIDENT OCCURRED DURING TRIAL SOFTWARE VALIDATION. THIS REPORT IS BEING FILED DUE TO THE SAFETY ALLEGATION OF HEMOLYSIS.

    Additional Manufacturer Narrative · 2

    (B)(4). INVESTIGATION EVAL AND CORRECTIVE ACTIONS ARE IN-PROCESS. A FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 2

    TWO RBC PRODUCT SAMPLES AT DAY-42 HAD HEMOLYSIS THAT EXCEEDED THE (B)(6) REQUIREMENT OF LESS THAN OR EQUAL TO (B)(4). DISPOSABLE SETS ARE NOT AVAILABLE TO BE RETURNED FOR INVESTIGATION. THIS INCIDENT OCCURRED DURING TRIAL SOFTWARE VALIDATION. THIS REPORT IS BEING FILED DUE TO THE SAFETY ALLEGATION OF HEMOLYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIMA ACCEL AUTO RBC AND PLS SET SEPARATOR, AUTOMATED, BLOOD CELL AND PL LKN CARIDIANBCT UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Other
    2 34 YR Other