BEUDAMED
    FDA Adverse Event Other Summary report: N

    SPECTRA OPTIA COLLECT SET

    MDR report key: 2181550 · Received July 18, 2011

    Report

    Report Number
    1722028-2011-00227
    Event Type
    Other
    Date Received
    July 18, 2011
    Date of Event
    June 6, 2011
    Report Date
    June 21, 2011
    Manufacturer
    CARIDIANBCT
    Product Code
    LKN
    PMA / PMN Number
    K103090
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DURING TWO SEPARATE APHERESIS FOR SELF-TRANSPLANTATION PROCEDURES, THE CUSTOMER RECEIVED "LEAK IN CENTRIFUGE" ALARMS. THE CUSTOMER REPORTED THAT THERE WAS BLOOD INSIDE THE MACHINE. THE RUNS WERE ENDED W/O BLOOD RINSEBACK, RESULTING IN LOSS OF RED BLOOD CELLS IN THE PTS. PER THE CUSTOMER, THERE WAS AN INCREASE IN ANEMIA, BUT THERE WAS NO CLINICAL CONSEQUENCE. PT WEIGHT IS NOT AVAILABLE AT THIS TIME. THE DISPOSABLE SETS ARE NOT AVAILABLE TO BE RETURNED FOR EVAL. THIS REPORT IS BEING FILED DUE TO UNK MEDICAL INTERVENTION PREVENTING ALLEGED ANEMIA. THE CUSTOMER FILED A REPORT WITH THEIR LOCAL AUTHORITIES.

    Additional Manufacturer Narrative · 2

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

    Description of Event or Problem · 2

    DURING TWO SEPARATE APHERESIS FOR SELF-TRANSPLANTATION PROCEDURES, THE CUSTOMER RECEIVED "LEAK IN CENTRIFUGE" ALARMS. THE CUSTOMER REPORTED THAT THERE WAS BLOOD INSIDE THE MACHINE. THE RUNS WERE ENDED W/O BLOOD RINSEBACK, RESULTING IN LOSS OF RED BLOOD CELLS IN THE PTS. PER THE CUSTOMER, THERE WAS AN INCREASE IN ANEMIA, BUT THERE WAS NO CLINICAL CONSEQUENCE. PT WEIGHT IS NOT AVAILABLE AT THIS TIME. THE DISPOSABLE SETS ARE NOT AVAILABLE TO BE RETURNED FOR EVAL. THIS REPORT IS BEING FILED DUE TO UNK MEDICAL INTERVENTION PREVENTING ALLEGED ANEMIA. THE CUSTOMER FILED A REPORT WITH THEIR LOCAL AUTHORITIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPECTRA OPTIA COLLECT SET SEPARATOR, AUTOMATED, BLOOD CELL AND PL LKN CARIDIANBCT 12S3114

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other
    2 65 YR