BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COBE SPECTRA APHERESIS SYSTEM

    MDR report key: 1890093 · Received October 28, 2010

    Report

    Report Number
    1722028-2010-00052
    Event Type
    Injury
    Date Received
    October 28, 2010
    Date of Event
    February 3, 2009
    Report Date
    October 29, 2010
    Manufacturer
    CARIDIANBCT
    Product Code
    LKN
    PMA / PMN Number
    K9000105
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): PRIOR TO RECEIVING THE KIT FROM THE CUSTOMER, INVESTIGATORS (ON FEBRUARY 5TH) RAN A TPE SET WITH THE COLLECT LINE BLOCKED BY A HEMOSTAT. THIS RESULTED IN PULSING OF THE PLASMA LINE TO THE WASTE BAG (ABOVE THE PUMP CARTRIDGE). IT DID NOT CAUSE THE MACHINE TO ALARM, AND THE SYSTEM STATED THAT IT WAS CONTINUING TO COLLECT PLASMA. DURING THE INVESTIGATION, A CLOSE EXAMINATION OF THE SEGMENT OF TUBING BETWEEN THE CCM AND THE 3-LUMEN CONNECTOR SHOWED NO EVIDENCE OF KINKING. THIS INDICATES THAT THE PRODUCT WAS NOT MIS-PACKAGED PRIOR TO STERILIZATION DUE TO THE ABSENCE OF A WELL-DEFINED KINK. THERE WAS NO DIFFERENCE IN THE TUBING LENGTHS OF RBC LINE AND WASTE PLASMA LINE WHEN COMPARED TO A REFERENCE SET. THE PLASMA LINE KINKING REFERRED TO BY THE OPERATOR IN THE INCIDENT DESCRIPTION MUST HAVE BEEN INDUCED BY THE SPECIFIC LOADING OF THE DISPOSABLE. IN SUMMARY, NO DISPOSABLE DEFECTS WERE NOTED. ROOT CAUSE: THE LIKELY ROOT CAUSE OF THIS EVENT IS OPERATOR LOADING OF THE KIT, WHICH CAUSED A SEVERE KINK IN THE TUBING BELOW THE CCM. CORRECTIVE/PREVENTIVE ACTION: A TREND REVIEW WAS CONDUCTED FOR THIS LOT. NO OTHER SIMILAR EVENTS FOR THIS LOT NUMBER HAVE BEEN REPORTED TO DATE. TRENDS SUGGEST THAT THE EVENT REPORTED IS RANDOM AND OCCURS AT A LOW LEVEL ON A GENERAL BASIS. TRENDS ARE REGULARLY MONITORED TO DETERMINE APPROPRIATE PREVENTATIVE AND CORRECTIVE ACTIONS BY MANUFACTURING OR ENGINEERING. NO FURTHER EVALUATION WILL BE DONE ON THIS SPECIFIC REPORT.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AS A RESULT OF CHANGES TO OUR MDR EVALUATION PROCESS THAT WERE PROMPTED BY AN FDA INSPECTION. ONE TIME DURING RINSEBACK, THE MACHINE ALARMED 'AIR DETECTED IN THE RETURN AIR CHAMBER' AND THERE WAS FOAM NOTED IN THE RETURN PRESSURE SENSOR AND THE RETURN AIR CHAMBER. ON VISUAL INSPECTION, IT WAS NOTED THAT THERE WAS A KINK IN THE TUBING BETWEEN THE CCM AND THE CONNECTOR JOINING ALL THE TUBES, THIS WAS RELEASED MANUALLY AND THE PULSATING STOPPED. IT WAS ALSO NOTED AT THAT POINT THAT THERE WAS LESS VOLUME IN THE REMOVE BAG THAN MIGHT HAVE BEEN EXPECTED. ON COMPLETION OF THE PROCEDURE, THE REMOVE BAG WAS WEIGHED AND CONTAINED 1.8 KG. ACCORDING TO SPECTRA, 2788MLS WERE REMOVED. THERE WAS APPROXIMATELY 1000MLS LESS IN THE BAG THAN EXPECTED. IN THE LAST 15 MINUTES OF THE PROCEDURE, THE COUGH BECAME SIGNIFICANTLY WORSE AND SHE BECAME QUITE UNCOMFORTABLE WITH IT. SHE WAS EXAMINED BY A MEDICAL PRACTITIONER. HER CHEST WAS CLINICALLY CLEAR, BUT SHE WAS COMMENCED ON ORAL ANTIBIOTICS IN VIEW OF HER COUGH AND IMMUNOSUPPRESSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBE SPECTRA APHERESIS SYSTEM SEPARATOR, AUTOMATED, BLOOD CELL AND PL LKN CARIDIANBCT 950000002 10P15222

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK