BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    QUANTUM

    MDR report key: 9526183 · Received December 27, 2019

    Report

    Report Number
    1722028-2019-00445
    Event Type
    Malfunction
    Date Received
    December 27, 2019
    Date of Event
    December 6, 2019
    Report Date
    December 27, 2019
    Manufacturer
    TERUMO BCT
    Product Code
    KJF
    UDI-DI
    05020583210127
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED TO PROVIDE ADDITIONAL INFORMATION IN H.6 AND H.10. INVESTIGATION: THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED FOR THIS LOT. THERE WERE NO ISSUES NOTED IN THE DHR THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. ALL QUALITY AND STERILITY LABS PASSED. INVESTIGATION IS IN PROCESS. A FOLLOW UP REPORT WILL BE PROVIDED.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED TO PROVIDE ADDITIONAL INFORMATION IN H6 & H10. INVESTIGATION : THE CUSTOMER SUBMITTED THREE PHOTGRAPHS IN LIEU OF THE DISPOSABLE SETS TO SUPPLEMENT THE INVESTIGATION. THE SHARED PHOTOGRAPHS CONFIRMED CONTAMINATION WAS EVIDENT IN THE IC CIRCULATION LOOP (BIOREACTOR IC OUTLET) AND A PRESSURE SENSOR. THE PH INDICATOR IN THE FLUID PRESENT IN THE EC CIRCULATION LOOP APPEARED TO BE NEUTRAL. PER LITERATURE REVIEW, STAPHYLOCOCCI ARE COMMON BACTERIAL COLONIZERS OF THE SKIN AND MUCOUS MEMBRANES OF HUMANS AND OTHER MAMMALS. S. EPIDERMIDIS IN PARTICULAR IS THE MOST FREQUENTLY ISOLATED SPECIES FROM HUMAN EPITHELIA. IT COLONIZES PREDOMINANTLY THE AXILLAE, HEAD, AND NARES. AS PART OF THE HUMAN EPITHELIAL MICROFLORA, S. EPIDERMIDIS USUALLY HAS A BENIGN RELATIONSHIP WITH ITS HOST. IN ADDITION TO THE ABUNDANCE OF S. EPIDERMIDIS ON THE SKIN, THIS HIGH FREQUENCY IS LIKELY DUE TO ELABORATE MECHANISMS TO COLONIZE CATHETER SURFACES. FURTHERMORE, S. EPIDERMIDIS MAY BE INVOLVED IN PROSTHETIC JOINT, VASCULAR GRAFT, SURGICAL SITE, CENTRAL NERVOUS SYSTEM SHUNT, AND CARDIAC DEVICE INFECTIONS. OTTO M. STAPHYLOCOCCUS EPIDERMIDIS--THE 'ACCIDENTAL' PATHOGEN. NAT REV MICROBIOL. 2009;7(8):555-567. DOI:10.1038/NRMICRO2182 PER INTERNAL LABORATORY DOCUMENTATION, THE DEVICES TERUMO BCT MANUFACTURES TO COLLECT, SEPARATE, AND STORE BLOOD PRODUCTS ARE TERMINALLY STERILIZED TO A STERILITY ASSURANCE LEVEL (SAL) OF </ =10-6. ADDITIONALLY, A STERILITY ASSURANCE SYSTEM HAS BEEN DESIGNED AND EMPLOYED TO ENSURE THIS SAL WILL BE ACHIEVED FOR EVERY LOT OF PRODUCT MANUFACTURED. THE STERILITY ASSURANCE SYSTEM EMPLOYED AT TERUMO BCT ENSURES THE DISPOSABLE DEVICE IS NOT THE SOURCE OF CONTAMINATION. ROOT CAUSE: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. POSSIBLE CAUSES OF CONTAMINATION INCLUDE BUT ARE NOT LIMITED TO: - CONTAMINATED CELL LINE. - NON-STERILE SAMPLING TECHNIQUE. - DISPOSABLE DEFECT - NON-STERILE DOCKING TECHNIQUE ADDITIONALLY, THE STERILITY ASSURANCE SYSTEM EMPLOYED AT TERUMO BCT ENSURES THE DEVICE IS NOT THE SOURCE OF CONTAMINATION.

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION IN A.1. INVESTIGATION: A DISPOSABLE LOT QUERY SEARCH WAS PERFORMED FOR LOT 05C9101 AND NO SIMILAR REPORTED OCCURRENCES HAVE BEEN RECEIVED. THE CUSTOMER CONFIRMED STERILITY TESTING ALL THE REAGENTS INVOLVED AND THE RESULTS WERE NEGATIVE. BASED ON THE STERILITY ASSURANCE SYSTEM EMPLOYED AT TERUMO BCT, THE DISPOSABLE DEVICE IS NOT THE SOURCE OF THE BACTERIAL CONTAMINATION. INVESTIGATION IS IN PROCESS. A FOLLOW UP REPORT WILL BE PROVIDED.

    Description of Event or Problem · 0

    THERE WAS NOT A TRANSFUSION RECIPIENT OR PATIENT INVOLVED AT THE TIME OF THIS INCIDENT, THEREFORE NO PATIENT INFORMATION IS REASONABLY KNOWN AT THE TIME OF THE EVENT.

    Additional Manufacturer Narrative · 1

    INVESTIGATION: PER THE CUSTOMER, THEY HAVE HAD OTHER RUNS WITH THE SAME LOT NUMBER WHICH HAVE NOT RESULTED IN CONTAMINATION BUT WANTED TO CONFIRM WITH TERUMO BCT TO DETERMINE IF THERE HAVE BEEN ANY OTHER SOURCES OF THE CONTAMINATION FROM SAMPLING OF THE REAGENTS THAT FEED INTO THE SET. THE CUSTOMER REACHED OUT TO TBCT TO INQUIRE HOW IT MIGHT BE POSSIBLE TO GET CONTAMINATION AS IT IS A CLOSED SYSTEM WITH FILTERS THAT SHOULD PREVENT CONTAMINANTS FROM ENTERING. INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED TO PROVIDE ADDITIONAL INFORMATION. INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED CONTAMINATION INSIDE THE QUANTUM DISPOSABLES SET AFTER SEVERAL DAYS OF PROCESSING OF THE PRODUCT. PER THE CUSTOMER, THE SOURCE OF THE CONTAMINATION IS UNKNOWN, BUT MAY HAVE INTRODUCED BY THEM DURING NORMAL PROCESSING PROCEDURE. THE CUSTOMER PERFORMED TESTING ON ALL OF THE REAGENTS ATTACHED TO THE SETS, BUT ALL TESTS HAVE SHOWN THEM TO BE STERILE. IT IS UNKNOWN AT THIS TIME IF THE UNIT WAS TRANSFUSED. PATIENT INFORMATION AND OUTCOME ARE UNKNOWN AT THIS TIME. THE DISPOSABLE SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

    Description of Event or Problem · 1

    DURING FOLLOW-UP WITH THE CUSTOMER, IT WAS REPORTED THAT AFTER TESTING, THE SPECIES THAT WERE ISOLATED WERE STAPHYLOCOCCUS EPIDERMIDIS AND STAPHYLOCOCCUS CAPITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1322764 QUANTUM QUANTUM CELL EXPANSION SET KJF TERUMO BCT 21012 04C9103 05020583210127

    Patients

    Seq Age Sex Outcome Treatment
    1 Other