BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERAPEUTIC PLASMA EXCHANGE SET

    MDR report key: 1890086 · Received October 28, 2010

    Report

    Report Number
    1722028-2010-00020
    Event Type
    Injury
    Date Received
    October 28, 2010
    Date of Event
    September 8, 2009
    Report Date
    October 29, 2010
    Manufacturer
    CARIDIANBCT
    Product Code
    LKN
    PMA / PMN Number
    K9000105
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DISPOSABLE KIT INVOLVED IN THIS EVENT WAS NOT RETURNED TO THE MANUFACTURER. A DHR REVIEW WAS CONDUCTED BASED ON THE LOT NUMBER OF THE KIT PROVIDED BY THE CUSTOMER. THE REVIEW SHOWED NO MANUFACTURING ANOMALIES OCCURRED DURING PRODUCTION AND NOTHING OF THIS TYPE OF INCIDENT WAS REPORTED FROM THIS LOT. STERILIZATION RECORDS DID NOT SHOW ANY ANOMALIES IN THE PROCESS EITHER. A SERVICE CALL WAS PLACED IMMEDIATELY AFTER THIS INCIDENT WAS REPORTED AND THE EQUIPMENT WAS CHECKED. THE SERVICE TECHNICIAN PERFORMED PREVENTATIVE MAINTENANCE VERIFICATIONS PER MANUFACTURER PROCEDURE AND FOUND THE MACHINE OPERATING PROPERLY WITHIN MANUFACTURER SPECIFICATIONS. A SALINE TPE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE SERVICE TECHNICIAN DID NOT INDICATE ANY ISSUES WITH THE EQUIPMENT, IT WAS WORKING FINE. THE PT REACTIONS LISTED BY THE CUSTOMER ARE ALL VERY TYPICAL ALLERGIC REACTIONS IN ASSOCIATION WITH FFP OR ALBUMIN TRANSFUSIONS. THE AMOUNT OF CITRATE IN FFP IS NOT KNOWN IN MOST CASES, BUT IT IS MUCH HIGHER THAN ANY OTHER REPLACEMENT FLUID. DEPENDING ON THE PT SENSITIVITY TO THE CITRATE, IT IS VERY POSSIBLE THAT THE PT WAS REACTING TO THE ELEVATED AMOUNT OF CITRATE. ALSO, ALBUMIN REACTIONS IN TPE PROCEDURE IS WELL KNOWN AS WELL. CONSIDERING THE KNOWN FFP AND ALBUMIN REACTIONS ON THE TPE PTS AND THE FACT THAT ALLERGY MEDICATIONS IMPROVED THE PT CONDITIONS, THESE REACTIONS WERE MOST LIKELY TO BE RELATED TO THE PT AND PROCEDURE MANAGEMENT ISSUES.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AS A RESULT OF CHANGES TO OUR MDR EVAL PROCESS THAT WERE PROMPTED BY AN FDA INSPECTION. A CUSTOMER WANTED TO DISCUSS AND GET OUR INPUT ABOUT A PT'S REACTIONS. THE PT HAD RECEIVED A TOTAL OF 19 TPE TREATMENTS AND HAD 6 REACTIONS. STARTING (B)(6) 2009, THE PT WITH MYASTHENIA GRAVIS WENT THROUGH 19 TPE TREATMENTS. OF THOSE TREATMENTS, THE PT EXHIBITED ALLERGIC REACTIONS ON 6 TREATMENTS. THE ALLERGIC REACTIONS INVOLVED WERE CHEST PAIN, TIGHTNESS, HEAVINESS, FLUSHING OF THE FACE, DIAPHORESIS, WHEEZING, INCREASE IN PULSE RATE AND DROP IN BLOOD PRESSURE. ON EACH REACTION EVENTS, THE PT RECEIVED MEDICATIONS FOR THESE ALLERGIC REACTIONS. THE PT CONDITION WAS IMPROVED AND THE PT WAS ABLE TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERAPEUTIC PLASMA EXCHANGE SET SEPARATOR, AUTOMATED, BLOOD CELL AND PL LKN CARIDIANBCT 01R15296

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention