BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRA OPTIA

    MDR report key: 3881352 · Received June 18, 2014

    Report

    Report Number
    1722028-2014-00238
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Date of Event
    March 3, 2014
    Report Date
    May 21, 2014
    Manufacturer
    TERUMO BCT
    Product Code
    LKN
    PMA / PMN Number
    BK120076
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THIS UNIT SHOWED NO IRREGULARITIES DURING MANUFACTURING THAT WERE RELEVANT TO THIS ISSUE. SEMIANNUAL PM WAS COMPLETED AND NO ISSUES WERE FOUND WITH THE EQUIPMENT. ROOT CAUSE: SINCE ANOTHER NEW SET PASSED PRIME WITHOUT A PROBLEM AND THE PART EVALUATION DID NOT SHOW ANY TUBING INTEGRITY ISSUES, THE POSSIBLE CAUSES INCLUDE BUT ARE NOT LIMITED TO: RETURN LINE WAS CLAMPED AND/OR THE RETURN SALINE LINE WAS NOT CLOSED.

    Additional Manufacturer Narrative · 1

    THIS RECORD WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF MDRS TO IDENTIFY RECORDS IN WHICH AN EVENT OCCURRED, BUT THE TYPE OF REPORTABLE EVENT WAS NOT INDICATED APPROPRIATELY. THIS SUPPLEMENT IS BEING FILED TO MODIFY INFORMATION TO ALIGN WITH THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    INVESTIGATION: THE DISPOSABLE SET WAS RETURNED FOR INVESTIGATION. THE SET CONTAINED PRIME SOLUTION. THE SET WAS VISUALLY INSPECTED FOR MISSING PARTS, MIS-ASSEMBLY, KINKS, OCCLUSIONS AND OTHER DEFECTS WHICH MAY HAVE CONTRIBUTED TO THE ISSUE, NONE WERE FOUND. THE SET WAS RETURNED WITH BOTH ROLLER CLAMPS CLOSED AND THE PINCH CLAMPS CLOSED AS WELL. ALL CLAMPS WERE TESTED TO ENSURE A PROPER OCCLUSION WAS MADE WHEN CLOSED. ALL CLAMPS APPEARED TO OCCLUDE PROPERLY. NO LEAKS WERE FOUND AND ALL TUBING CONNECTIONS APPEARED TO BE ADEQUATE. THE ALARM EXPERIENCED BY THE CUSTOMER INDICATES THAT THE PRESSURE LIMIT HAS BEEN REACHED. A REVIEW OF THE LOT FOR SIMILAR REPORTS WAS CARRIED OUT, NONE HAVE BEEN REPORTED. ROOT CAUSE: INVESTIGATION INTO THIS OCCURRENCE DID NOT FIND A DEFINITIVE ROOT CAUSE FOR THE PRESSURE SENSOR FAILURE. THE RESULTS FROM OUR INVESTIGATION SUGGESTS THIS ISSUE IS MOST LIKELY CAUSE BY (BUT NOT LIMITED TO) THE FOLLOWING:- SALINE LINE CLAMPED. -INCORRECT PRESSURE SENSOR CALIBRATION.- DEFECTIVE PRESSURE SENSOR.- DEFECTIVE CONTROL STACK.

    Description of Event or Problem · 1

    THE CUSTOMER DECLINED TO PROVIDE PATIENT INFORMATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING SETUP FOR A MONONUCLEAR CELL (MNC) COLLECTION PROCEDURE,THEY RECEIVED MULTIPLE 'RETURN SALINE LINE FAILED INTEGRITY TEST' ALARMS. THE RN ABORTED THE PROCEDURE AND PRIMED A NEW DISPOSABLE SET, WITH NO PROBLEMS. PATIENT INFORMATION IS NOT AVAILABLE AT THIS TIME. THIS REPORT IS BEING FILED IN RESPONSE TO THE CUSTOMER FILING A MEDWATCH REPORT, WHICH WAS FOUND DURING AN INTERNAL MAUDE DATABASE SEARCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357644 SPECTRA OPTIA SPECTRA OPTIA COLLECT SET LKN TERUMO BCT 06V3326

    Patients

    Seq Age Sex Outcome Treatment
    1 Other