BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COBE SPECTRA APHERESIS SYSTEM TPE SET

    MDR report key: 1890090 · Received October 28, 2010

    Report

    Report Number
    1722028-2010-00039
    Event Type
    Injury
    Date Received
    October 28, 2010
    Date of Event
    January 17, 2010
    Report Date
    October 29, 2010
    Manufacturer
    CARIDIANBCT
    Product Code
    LKN
    PMA / PMN Number
    K9000105
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FIELD DIAGNOSTIC/CORRECTION: COMPLETE PROCEDURAL DETAILS ARE UNK. ALBUMIN WAS USED AS THE REPLACEMENT SOLUTION. THE CUSTOMER SUSPECTED THAT THE ALBUMIN CAUSED THE REACTION, BUT THEY KNEW ALBUMIN FROM THE SAME LOT HAD BEEN USED ON OTHER PTS WITHOUT INCIDENT. INVESTIGATION: THE ALBUMIN USED WAS A COMMERCIAL 5% SOLUTION THAT WAS NOT PREPARED AT THE PHARMACY; THEREFORE, THE INCIDENT WAS NOT RELATED TO IMPROPER PREPARATION OF REPLACEMENT FLUID. A WEB SEARCH OF THE ALBUMIN LOT NUMBER WAS PERFORMED AND THERE WERE NO FINDINGS OF RECALL NOTIFICATIONS IN THE U.S. RELATED TO THAT LOT NUMBER. REVIEW OF THE MANUFACTURING RECORDS FOR THIS LOT OF SPECTRA DISPOSABLES INDICATED THAT THE PRODUCT MET ALL STERILIZATION AND AERATION RELEASE CRITERIA. THIS DISPOSABLE SET WAS UNAVAILABLE TO RETURN FOR INVESTIGATION. ROOT CAUSE: AT THE TIME OF THIS INVESTIGATION, THERE WAS NO CONCLUSIVE EVIDENCE SUGGESTING THAT THE REACTION WAS CAUSED BY THE DISPOSABLE OR THE EQUIPMENT. POTENTIAL CAUSES FOR THE REACTION INCLUDE, BUT ARE NOT LIMITED TO: A SUBSTANCE THAT THE PT WAS EXPOSED TO INDEPENDENT OF THE PROCEDURE, THE SOLUTIONS USED DURING THE PROCEDURE. RISK ANALYSIS: THE PT WAS NOT REPORTED TO HAVE EXPERIENCED PERMANENT INJURY OR ANY NON-TRANSIENT EFFECTS FROM THE EPISODE. FOR ALL COBE SPECTRA DISPOSABLE LOTS MANUFACTURED IN THE SAME YEAR AS THE DISPOSABLE KIT USED IN THIS INCIDENT, THE RATE OF ALL PT REACTIONS REPORTED WAS 0.000019, AS CALCULATED AT THE TIME OF THIS INVESTIGATION. FURTHER TREND ANALYSIS SUGGESTS THAT THE EVENT REPORTED IS RANDOM AND ISOLATED ON A GENERAL BASIS.

    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. THE FOLLOWING INCIDENT WAS REPORTED TO CARIDIANBCT QUALITY ASSURANCE ON (B)(6) 2010. ON (B)(6) 2010 A PT WITH MULTIPLE SCLEROSIS HAD A SIGNIFICANT ALLERGIC REACTION ALL OVER THE BODY ABOUT 12 HOURS AFTER A TPE PROCEDURE. THE PT MADE A FULL RECOVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBE SPECTRA APHERESIS SYSTEM TPE SET SEPARATOR, AUTOMATED, BLOOD CELL AND PL LKN CARIDIANBCT 08P15234

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other