BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COBE SPECTRA APHERESIS SYSTEM

    MDR report key: 1973823 · Received January 14, 2011

    Report

    Report Number
    1722028-2010-00074
    Event Type
    Injury
    Date Received
    January 14, 2011
    Date of Event
    April 8, 2009
    Report Date
    January 14, 2011
    Manufacturer
    CARIDIANBCT
    Product Code
    LKN
    PMA / PMN Number
    K9000105
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION: WHILE THE MACHINE WAS DETERMINED TO OPERATE WITHIN MANUFACTURER'S SPECIFICATIONS DURING EVALUATION IT WAS NOTED THAT THE BATTERY VOLTAGE WAS READING LOW AND THAT THE COLLECT PUMP WAS NOT ROTATING SMOOTHLY AT LOW SPEEDS. BOTH COMPONENTS WERE PRO ACTIVELY REPLACED. THE RETURNED PUMP MOTOR WAS VERIFIED TO EXHIBIT A SLIGHT JERKING MOTION BUT PASSED FUNCTIONAL TESTING. PER THE STAFF THE MACHINE PERFORMED PROPERLY DURING THE PROCEDURE. THERE WAS NO ALLEGATION THAT THE MACHINE NOR THE PROCEDURE CAUSED THE EVENT BUT THE FACILITY REQUIRES ALL MACHINES TO BE CHECKED OUT IF THERE IS A PT EVENT. THE BLOOD TUBING SET USED ON THE MACHINE WAS NOT AVAILABLE FOR INVESTIGATION. LOT/SN HISTORY REVIEW WAS CONDUCTED AND DID NOT INDICATE ANY PREVIOUS MACHINE PROBLEM SERVICE CALLS THAT WOULD INDICATE A PT SAFETY CONCERN. CONCLUSION: LIKELY THE CAUSE OF THE ISSUE WAS DUE TO THE PT'S CONDITION. THERE WAS NO ALLEGATION THAT THE SPECTRA MACHINE WAS A CAUSE OR CONTRIBUTION TO THE PT EVENT. THE SPECTRA DEVICE PERFORMED TO SPECIFICATION.

    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. THE CUSTOMER REPORTED THAT AFTER A RED CELL EXCHANGE A PT HAD A SEIZURE. THIS OCCURRED ABOUT 45 MINUTES AFTER THE PROCEDURE. THE PT WAS IN THE HOSPITAL AND WAS STABILIZED IN THE EMERGENCY ROOM. THE NURSE WHO PERFORMED THE PROCEDURE STATED THAT THE PT DID FINE DURING THE PROCEDURE. THEY TOOK THE PT TO THE RADIOLOGY DEPARTMENT 45 MINUTES AFTER THE PROCEDURE TO REMOVE THEIR CATHETER AND THAT IS WHEN THE SEIZURE EVENT OCCURRED. THE PHYSICIAN IN THE EMERGENCY ROOM STATED THAT THE PT WAS HAVING ORTHOSTATIC EVENTS (DIZZY SPELLS OR HYPOTENSION WHEN THE PT STANDS UP). NEITHER THE NURSE, THE PHYSICIAN, NOR ANYONE AT THE FACILITY IS IMPLICATING THE SPECTRA EQUIPMENT IN THE EVENT. CUSTOMER SUPPORT CHECKED WITH THE CUSTOMER SITE TO FIND OUT THE PT'S CONDITION AFTER THE EVENT AND THE PT WAS DOING FINE AND IN A STABLE STATE. MULTIPLE ATTEMPTS TO OBTAIN PT IDENTIFIER INFORMATION WERE UNSUCCESSFUL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention