BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRA OPTIA

    MDR report key: 4171020 · Received October 14, 2014

    Report

    Report Number
    1722028-2014-00413
    Event Type
    Malfunction
    Date Received
    October 14, 2014
    Date of Event
    September 18, 2014
    Report Date
    September 19, 2014
    Manufacturer
    TERUMO BCT
    Product Code
    LKN
    PMA / PMN Number
    BK120012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: PER THE CUSTOMER, THEY PRIMED THE MACHINE WITH ANOTHER TUBING SET AND DIDN'T GET A REPEAT ALARM. THEY CONNECTED THE PATIENT TO THE NEW TUBING SET, AND STARTED THE PROCEDURE. THEY WERE UNABLE TO COMPLETE THE PROCEDURE DUE TO ACCESS ISSUES RELATED TO POOR FLOW AND A SMALL-DIAMETER CATHETER. THE CATHETER WAS REPLACED THE NEXT DAY AND THEY DID A PROCEDURE WITHOUT ANY PROBLEMS ON (B)(6) 2014. SINCE THEN, THEY HAVE DONE 2 MORE PROCEDURES ON THE SAME MACHINE WITHOUT RETURN LINE AIR DETECTOR (RLAD) ALARMS. INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

    Additional Manufacturer Narrative · 1

    ROOT CAUSE: THE REPORTED ALARM COULD NOT BE CONFIRMED. A DEFINITIVE ROOT CAUSE FOR THE OTHER ALARMS SEEN IN THE RDF COULD NOT BE DETERMINED. SPIKING THE FLUID CONTAINERS SOONER THAN THE SYSTEM EXPECTS COULD CAUSE THE ALARMS EXPERIENCED BY THE CUSTOMER. THE DEVICE OPERATED AS INTENDED BY PROVIDING THE FAIL-SAFE ALARMS.

    Additional Manufacturer Narrative · 1

    INVESTIGATION: A REVIEW OF THE LAST YEAR OF SERVICE HISTORY FOR THIS DEVICE INDICATED NO OTHER REPORTS RELATED TO THIS ISSUE. THE RUN DATA FILE (RDF) WAS ANALYZED FOR THIS EVENT. THE REPORTED ALARM COULD NOT BE CONFIRMED IN THE RDF. THERE MAY HAVE BEEN SOME ISSUES WITH SETTING UP THE SET DURING SALINE PRIME AND IT IS POSSIBLE THE OPERATOR SPIKED THE FLUID TOO SOON OR DID NOT OPEN THE SALINE CLAMPS AT THE TIME THE SYSTEM INSTRUCTED. INVESTIGATION IS IN-PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A ¿RETURN LINE AIR DETECTOR DETECTED FLUID TOO SOON¿ ALARM DURING PRIMING FOR A THERAPEUTIC PLASMA EXCHANGE (TPE) PROCEDURE. THE CUSTOMER STATED SHE COULD NOT RECALL SEEING AIR OR FLUID IN THE RETURN LINE AT THE TIME OF THE ALARM. THE CUSTOMER HAD NOT WITNESSED THE OPERATOR¿S LOADING OR INITIATION OF PRIMING FOR THE PROCEDURE. THE ONLY OPTION THE MACHINE GAVE AFTER THE ALARM WAS TO DISCONNECT. NO MEDICAL INTERVENTION WAS NEEDED FOR THIS EVENT. THE PATIENT'S CONDITION IS STABLE. THE DISPOSABLE KIT IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER. THIS REPORT IS BEING FILED DUE TO DEVICE MALFUNCTION THAT HAS THE POTENTIAL FOR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650914 SPECTRA OPTIA SPECTRA OPTIA APHERESIS SYSTEM LKN TERUMO BCT 000000000000061000

    Patients

    Seq Age Sex Outcome Treatment
    1 00017 YR Other