BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELLEX PHOTOPHERESIS SYSTEM

    MDR report key: 7795038 · Received August 17, 2018

    Report

    Report Number
    2523595-2018-00125
    Event Type
    Malfunction
    Date Received
    August 17, 2018
    Date of Event
    July 19, 2018
    Report Date
    September 21, 2018
    Manufacturer
    THERAKOS, INC.
    Product Code
    LNR
    UDI-DI
    20705030200003
    PMA / PMN Number
    P860003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: THE CUSTOMER DID NOT RETURN PRODUCT FOR INVESTIGATION. DEVICE AVAILABLE FOR EVALUATION? NO. DEVICE EVALUATED BY MANUFACTURER? NOT RETURNED TO MANUFACTURER. CORRECTION: THE ASSESSMENT IS BASED ON THE INFORMATION AVAILABLE AT THE TIME OF INVESTIGATION. NO PRODUCT WAS RETURNED FOR INVESTIGATION; THEREFORE, IT COULD NOT BE DETERMINED IF THE PRODUCT MET SPECIFICATION BASED SOLELY ON THE INFORMATION PROVIDED BY THE CUSTOMER. COMPLAINTS ARE MONITORED THROUGH TRACKING AND TRENDING. IF A TREND IS DETECTED, FURTHER INVESTIGATION WILL BE CONDUCTED. INVESTIGATION COMPLETE. MC: 030980 P.T. 09/21/2018

    Description of Event or Problem · 0

    THE CUSTOMER CALLED TO REPORT A CENTRIFUGE BOWL LEAK/BREAK DURING THE TREATMENT PROCEDURE. THE CUSTOMER REPORTED THE BREAK OCCURRED DURING THE PURGING AIR PHASE OF THE TREATMENT PROCEDURE AND APPROXIMATELY 200 ML OF WHOLE BLOOD WAS PROCESSED. THE CUSTOMER ABORTED THE TREATMENT AND DID NOT RETURN BLOOD TO THE PATIENT. THE CUSTOMER STATED THE PATIENT WAS STABLE AND ASYMPTOMATIC. THE CUSTOMER HAS DISCARDED THE KIT.

    Additional Manufacturer Narrative · 1

    THE SYSTEM WAS USED FOR TREATMENT. THIS CASE IS REPORTABLE AS A MDR DUE TO THE REPORTABLE MALFUNCTION CENTRIFUGE BOWL LEAK/BREAK. SINCE THIS REPORTABLE MALFUNCTION IS ONLY ASSOCIATED WITH THE KIT, THIS MDR WILL ONLY BE AGAINST THE KIT. A BATCH RECORD REVIEW FOR KIT LOT G314 WAS CONDUCTED. THERE WERE NO NON-CONFORMANCES RELATED TO THE COMPLAINT. THIS LOT MET ALL RELEASE REQUIREMENTS. A REVIEW OF KIT LOT G314 SHOWS NO TRENDS. TRENDS WERE REVIEWED FOR COMPLAINT CATEGORY, CENTRIFUGE BOWL LEAK/BREAK. NO TRENDS WERE DETECTED FOR THIS COMPLAINT CATEGORY. THIS ASSESSMENT IS BASED ON THE INFORMATION AVAILABLE AT THE TIME OF THE INVESTIGATION. AT THE TIME OF THIS REPORT, THE ANALYSIS OF THE RETURNED KIT IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE FILED WHEN THE ANALYSIS IS COMPLETE. (B)(4) / (B)(6) 2018.

    Description of Event or Problem · 1

    THE CUSTOMER CALLED TO REPORT A CENTRIFUGE BOWL LEAK/BREAK DURING THE TREATMENT PROCEDURE. THE CUSTOMER REPORTED THE BREAK OCCURRED DURING THE PURGING AIR PHASE OF THE TREATMENT PROCEDURE AND APPROXIMATELY 200 ML OF WHOLE BLOOD WAS PROCESSED. THE CUSTOMER ABORTED THE TREATMENT AND DID NOT RETURN BLOOD TO THE PATIENT. THE CUSTOMER STATED THE PATIENT WAS STABLE AND ASYMPTOMATIC. THE CUSTOMER HAS RETURNED THE KIT FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636395 CELLEX PHOTOPHERESIS SYSTEM CELLEX PHOTOPHERESIS SYSTEM LNR THERAKOS, INC. NOT APPLICABLE G314 20705030200003

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR