BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRA OPTIA

    MDR report key: 4101392 · Received September 19, 2014

    Report

    Report Number
    1722028-2014-00376
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 21, 2014
    Report Date
    August 21, 2014
    Manufacturer
    TERUMO BCT
    Product Code
    LKN
    PMA / PMN Number
    BK130065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: PER THE CUSTOMER, THE RN CLOSED THE ACCESS SALINE LINE CLAMP AND CONTINUED THE PROCEDURE. THEY HAVE CONTINUED TO USE THE SPECTRA OPTIA SYSTEM WITHOUT ANY FURTHER PROBLEMS. INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION: THE DISPOSABLE SET WAS UNAVAILABLE FOR RETURN AND INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THIS UNIT SHOWED NO IRREGULARITIES DURING MANUFACTURING THAT WERE RELEVANT TO THIS ISSUE. A REVIEW OF THE LOT FOR SIMILAR REPORTS WAS CARRIED OUT AND NONE HAVE BEEN REPORTED. ROOT CAUSE: THE INLET SALINE LINE ROLLER CLAMP WAS UNINTENTIONALLY LEFT IN THE OPEN POSITION, ALLOWING SOME SALINE TO BE RETURNED TO THE PATIENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AT THE BEGINNING OF A MONONUCLEAR CELL COLLECTION (MNC) PROCEDURE,THEY RECEIVED A 'INTERFACE IS TAKING TOO LONG TO ESTABLISH' ALARM. THE CUSTOMER CONTACTED TERUMO BCT SUPPORT SPECIALIST FOR TROUBLESHOOTING. THE SUPPORT SPECIALIST HAD HER CHECK THE DISPOSABLE SET LOADING AND THE SALINE ROLLERS TO MAKE SURE THEY WERE CLOSED. THE CUSTOMER DISCOVERED THAT SHE HAD LEFT THE ACCESS SALINE LINE OPEN. NO MEDICAL INTERVENTION WAS NECESSARY FOR THIS EVENT. THE PATIENT IS REPORTED IN STABLE CONDITION AND WAS ABLE TO GO HOME AFTER THE COLLECTION. THE CUSTOMER DECLINED TO PROVIDE PATIENT'S DENTIFER AND WEIGHT. THE DISPOSABLE KIT IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER. THIS REPORT IS BEING FILED DUE TO INSUFFICIENT INFORMATION PROVIDED AT THIS TIME TO DETERMINE IF THE DEVICE MALFUNCTION THAT OCCURRED HAD THE POTENTIAL FOR DEATH OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581379 SPECTRA OPTIA SPECTRA OPTIA COLLECT SET LKN TERUMO BCT 07W3201

    Patients

    Seq Age Sex Outcome Treatment
    1 00018 MO Other