BEUDAMED
    FDA Adverse Event Other Summary report: N

    COBE SPECTRA APHERESIS SYSTEM

    MDR report key: 1940927 · Received December 17, 2010

    Report

    Report Number
    1722028-2010-00084
    Event Type
    Other
    Date Received
    December 17, 2010
    Date of Event
    June 20, 2009
    Report Date
    December 17, 2010
    Manufacturer
    CARIDIANBCT
    Product Code
    LKN
    PMA / PMN Number
    K9000105
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RISK ANALYSIS: SPECTRA AUTOPBSC COLLECT VOLUME ACCURACY BUG - (B)(4) RESULTED IN A HAZARD RISK INDEX OF 5 (LOW). A MODERATE, REVERSIBLE INJURY (HYPOTENSION OR HEMORRHAGE) REQUIRING PLASMA OR PLATELET TRANSFUSION IS UNLIKELY BUT POSSIBLE. FIELD DIAGNOSIS/CORRECTION: CARIDIANBCT CUSTOMER SUPPORT SPECIALIST, (B)(6), SPOKE WITH THE CUSTOMER. THE CUSTOMER WAS INFORMED THAT THE PROPER WAY TO ADJUST THE VOLUME IN THE CASE WAS TO GO INTO THE TARGET VOLUME ADJUSTMENT AND ENTER "ZERO" FOR THE COLLECT VOLUME. THE CUSTOMER ACKNOWLEDGED THAT THIS WAS THEIR PROTOCOL AND THE OPERATOR MADE A MISTAKE. INVESTIGATION: THIS CUSTOMER PROCESSES LARGE VOLUMES (30 LITERS) WHEN THEY DO PBSC COLLECTIONS USING MNC. AT ABOUT 29 LITERS, THE TECH DOING THE PROCEDURE ENTERED A TARGET PLASMA COLLECT VOLUME OF 100 MLS. COBE SPECTRA COLLECTED 100MLS OF PLASMA, BUT THEN THE PLASMA VALVE RE-OPENED AND BEGAN COLLECTING THE 100MLS OF PLASMA AGAIN. THE OPERATOR HEARD THE VALVE OPEN AND INSTEAD OF GOING INTO TARGET AND ZEROING OUT THE PLASMA COLLECT VOLUME AS IS THEIR POLICY, SHE PUT A HEMOSTAT ON THE PLASMA COLLECT LINE. THIS CAUSED THE LINE TO TEAR. THE OPERATOR WAS ABLE TO HEAT SEAL THE LINE BELOW THE TEAR, AND COMPLETE THE PROCEDURE. THE STEM CELL PRODUCT WAS OK AND THE CELL LAB USED ALBUMIN TO PROCESS THE STEM CELLS. THE COLLECTION WAS ON A DONOR FOR A PT AND ALL THE INFECTIOUS DISEASE TESTING HAD BEEN COMPLETED PRIOR TO COLLECTION AND IS NEGATIVE. CONCLUSION: OPERATOR INCORRECTLY CLAMPED LINE, CAUSING EXCESS PRESSURE. SOFTWARE BUG WAS THE REASON THAT THE OPERATOR HAD TO INTERACT WITH THE MACHINE.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AS A RESULT OF CHANGES TO OUR MDR EVALUATION PROCESS. WE HAVE CHANGED OUR PROCESS TO BETTER ALIGN WITH CURRENT AGENCY POLICY. CUSTOMER CALLED TO REPORT BLOOD SPILL THAT THEY WERE TREATING AS AN 'EXPOSURE INCIDENT', WHICH OCCURRED ON COBE SPECTRA (B)(4) DURING AN AUTOPBSC COLLECTION. THE MANAGER JUST CALLED IN ABOUT THE PLASMA RE-COLLECTION ASPECT, AND NOT TO COMPLAIN OR ALLEGE THAT THERE IS A PROBLEM WITH THE DEVICE. THIS REPORT IS BEING FILED DUE TO THE POTENTIAL FOR HYPOVOLEMIA DUE TO OVERCOLLECTION OF PLASMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBE SPECTRA APHERESIS SYSTEM SEPARATOR, AUTOMATED, BLOOD CELL AND PL LKN CARIDIANBCT 71000

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention