BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRA OPTIA

    MDR report key: 5841430 · Received August 2, 2016

    Report

    Report Number
    1722028-2016-00439
    Event Type
    Malfunction
    Date Received
    August 2, 2016
    Date of Event
    July 7, 2016
    Report Date
    August 2, 2016
    Manufacturer
    TERUMO BCT
    Product Code
    LKN
    PMA / PMN Number
    BK120012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION: A ONE YEAR SERVICE HISTORY INDICATES THIS ISSUE HAS OCCURRED PREVIOUSLY AND THAT THE RETURN LINE AIR DETECTOR (RLAD) HAS NOT BEEN REPLACED WITH A NEW STYLE DETECTOR TO DATE. THE DEVICE FAILED SAFE WITH AN ALARM. CORRECTIVE AND PREVENTIVE ACTION: AN INTERNAL CAPA HAS BEEN INITIATED TO EVALUATE REPORTS OF RLAD FAILURES. INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

    Additional Manufacturer Narrative · 1

    PER TERUMO BCT¿S MEDICAL REVIEW, THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO THIS INCIDENT.

    Additional Manufacturer Narrative · 1

    INVESTIGATION: THE RUN DATA FILE (RDF) WAS ANALYZED FOR THIS EVENT. REVIEW OF THE RDF ASSOCIATED WITH THIS COMPLAINT CONFIRMS THE OCCURRENCE OF THE ¿AIR WAS DETECTED IN RETURN LINE¿ALARM A TOTAL OF 10 TIMES DURING THIS PROCEDURE, WITH THE FIRST ALARM OCCURRING APPROXIMATELY 40MINUTES INTO THE PROCEDURE. AFTER EACH OF THE FIRST NINE OCCURRENCES OF THE ALARM, THE OPERATOR ATTEMPTED TO PERFORM THE AIR REMOVAL SEQUENCE. THE PROCEDURE WAS ONLY ABLE TO CONTINUE FOR 1-2 MINUTES AFTER EACH AIR REMOVAL OPERATION BEFORE THE NEXT ALARM WAS GENERATED. AFTER THE NINTH ALARM AND ATTEMPT TO REMOVE THE AIR FROM THE RETURN LINE, THE OPERATOR INITIATED A COLLECTION PHASE AND ENDED THE PROCEDURE. DURING RINSEBACK, A SUBSEQUENT RETURN LINE AIR DETECTOR(RLAD) ALARM WAS GENERATED AND THE OPERATOR PROCEEDED TO END THE RUN WITHOUT COMPLETING RINSEBACK. THE RDF WAS ALSO EVALUATED BY TERUMO BCT'S I&D DATABASE ADMINISTRATOR. SIGNALS IN THE RDF DID NOT SHOW A LARGE JUMP IN ACCUMULATED AIR WHICH IS INDICATIVE OF A DECOUPLED RLAD. THE ACCUMULATED AIR DEVELOPS INCREMENTALLY OVER TIME. ROOT CAUSE: A DEFINITIVE CAUSE FOR THE ¿AIR WAS DETECTED IN RETURN LINE¿ ALARM IS UNDETERMINED. POSSIBLE CAUSES INCLUDE, BUT ARE NOT LIMITED TO:-TUBING IS NOT CORRECTLY SEATED IN THE RETURN PUMP (WHICH CAN CAUSE THE RLAD TO DETECT AIR INSTEAD OF FLUID IN THE TUBING)-FOAM OR AIR IN THE RETURN LINE-DEFECTIVE RETURN LINE AIR DETECTOR-MACHINE ISSUE

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED TO PROVIDE ADDITIONAL INFORMATION IN DESCRIBE EVENT OR PROBLEM, EVALUATION CODES AND ADDITIONAL MFR NARRATIVE. ADDITIONAL INVESTIGATION: TERUMO BCT'S SERVICE TECHNICIAN VISUALLY INSPECTED THE DEVICE AT THE CUSTOMER SITE AND WAS ABLE TO DUPLICATE THE REPORTED CONDITION. THE RLAD DETECTOR WAS REPLACED WITH A NEW STYLE DETECTOR TO DATE. THE MACHINE IS FUNCTIONING PER MANUFACTURER'S SPECIFICATION. THE OLD STYLE RLAD ASSEMBLY WAS RETURNED FOR EVALUATION. UPON VISUAL INSPECTION, NO ANOMALIES WERE NOTED. THE PART WAS INSTALLED IN AN OPTIA SYSTEM TESTBED AND AN RLAD FUNCTIONAL TEST WAS SUCCESSFULLY COMPLETED. THE REPORTED CONDITION COULD NOT BE DUPLICATED DURING THE EVALUATION OF THE OLD STYLE RLAD IN THE LAB. THIS ADDITIONAL INVESTIGATION DOES NOT ALTER THE PREVIOUSLY REPORTED ROOT CAUSE.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED TO CORRECT INFORMATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A PEDIATRIC INPATIENT UNDERWENT A MONONUCLEAR CELL (MNC)COLLECTION PROCEDURE AFTER A BONE MARROW TRANSPLANTATION. DURING PRIME OF THE PROCEDURE, THEY RECEIVED MULTIPLE 'RETURN LINE AIR DETECTOR FAILED FLUID CHECK' ALARMS. THE OPERATOR STOPPED AND ABORTED THE PROCEDURE IMMEDIATELY WITHOUT RETURNING BLOOD BACK TO THE PATIENT. PER PHYSICIAN'S ORDER, THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU) ANDA RED BLOOD CELL (RBC) AND PLASMA TRANSFUSION WERE GIVEN TO THE PATIENT. PER THE CUSTOMER, THE PATIENT WAS ALSO GIVEN 'SPECIAL DRUG TREATMENT WITH LIFE-SAVING TECHNOLOGIES'. PATIENT OUTCOME IS NOT AVAILABLE AT THIS TIME. PATIENT IDENTIFIER, GENDER, AND WEIGHT ARE NOT AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    PATIENT'S (DONOR) GENDER AND WEIGHT WERE OBTAINED FROM THE RUN DATA FILE (RDF).THE CUSTOMER DECLINED TO PROVIDE THE PATIENT IDENTIFIER.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THE PATIENT REMAINED HOSPITALIZED.

    Description of Event or Problem · 1

    PER THE CUSTOMER, THE PATIENT IS STILL HOSPITALIZED AND RECEIVED 'SOME KIND OF THERAPY'. THE THERAPY WAS NON-RELATED WITH THIS EVENT. THE CUSTOMER STATED THAT THE PATIENT HAS GENERAL ONCOLOGY HEALTH PROBLEMS.

    Description of Event or Problem · 1

    DUE TO EU PERSONAL DATA PROTECTION LAWS, THE PATIENT IDENTIFIER IS NOT AVAILABLE FROM THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    493110 SPECTRA OPTIA SPECTRA OPTIA APHERESIS SYSTEM LKN TERUMO BCT 61000

    Patients

    Seq Age Sex Outcome Treatment
    1 00010 YR Hospitalization| O| R