BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRA OPTIA

    MDR report key: 11485299 · Received March 15, 2021

    Report

    Report Number
    1722028-2021-00108
    Event Type
    Malfunction
    Date Received
    March 15, 2021
    Date of Event
    February 11, 2021
    Report Date
    March 15, 2021
    Manufacturer
    TERUMO BCT
    Product Code
    GKT
    UDI-DI
    05020583121201
    PMA / PMN Number
    BK150251
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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. CORRECTED INFORMATION IS PROVIDED IN H.10. INVESTIGATION: PER LITERATURE REVIEW: ESCHERICHIA COLI IS A GRAM-NEGATIVE BACTERIUM AND IS THE MOST NUMEROUS AEROBIC COMMENSAL INHABITANT OF THE LARGE INTESTINE. CERTAIN STRAINS CAUSE DIARRHEA AND ALL CAN CAUSE INFECTION WHEN THEY INVADE STERILE SITES. INFECTION OF THE BLOODSTREAM REMAINS A LIFE-THREATENING OCCURRENCE AND IS MOST COMMONLY ASSOCIATED WITH THE PRESENCE OF A CENTRAL VASCULAR CATHETER, BUT MAY ALSO BE ASSOCIATED WITH A GRAM-NEGATIVE INFECTION IN OTHER AREAS OF THE BODY, SUCH AS THE LUNG, GENITOURINARY TRACT, OR ABDOMEN. APPROXIMATELY 30% OF HOSPITAL-ACQUIRED BLOODSTREAM INFECTIONS IN ICUS IN THE UNITED STATES ARE DUE TO GRAM-NEGATIVE ORGANISMS, ALTHOUGH THIS PROPORTION IS LOWER WHEN HOSPITAL-WIDE DATA ARE EXAMINED. GIVEN AN ADEQUATE PORTAL OF ENTRY, ALMOST ANY GRAM-NEGATIVE ORGANISM CAN CAUSE BLOODSTREAM INFECTION; HOWEVER, THE MOST COMMON ORGANISMS INCLUDE KLEBSIELLA SPECIES, ESCHERICHIA COLI, ENTEROBACTER SPECIES, AND P. AERUGINOSA. [A.Y. PELEG ET AL. HOSPITAL-ACQUIRED INFECTIONS DUE TO GRAM-NEGATIVE BACTERIA. N ENGL J MED. 2010 MAY 13; 362(19): 1804¿1813.] ACCORDING TO THE CDC 'GUIDELINES FOR THE PREVENTION OF INTRAVASCULAR CATHETER-RELATED INFECTIONS (2011)': IN THE UNITED STATES, 15 MILLION CENTRAL VASCULAR CATHETER (CVC) DAYS (I.E., THE TOTAL NUMBER OF DAYS OF EXPOSURE TO CVCS AMONG ALL PATIENTS IN THE SELECTED POPULATION DURING THE SELECTED TIME PERIOD) OCCUR IN INTENSIVE CARE UNITS (ICUS) EACH YEAR. STUDIES HAVE VARIOUSLY ADDRESSED CATHETER RELATED BLOODSTREAM INFECTIONS (CRBSI). THESE INFECTIONS INDEPENDENTLY INCREASE HOSPITAL COSTS AND LENGTH OF STAY, BUT HAVE NOT GENERALLY BEEN SHOWN TO INDEPENDENTLY INCREASE MORTALITY. WHILE 80,000 CRBSIS OCCUR IN ICUS EACH YEAR, A TOTAL OF 250,000 CASES OF BSIS HAVE BEEN ESTIMATED TO OCCUR ANNUALLY, IF ENTIRE HOSPITALS ARE ASSESSED. ROOT CAUSE: A DEFINITIVE ROOT CAUSE FOR THE CONTAMINATED CAR T CELL PRODUCTS COULD NOT BE DETERMINED. IT'S POSSIBLE THE PATIENT HAD A LOW LEVEL CATHETER RELATED BLOOD STREAM INFECTION (CRBSI) OR A NON-CATHETER RELATED INFECTION IN ANOTHER PART OF THE BODY. CORRECTED INVESTIGATION: "FEMORAL VEIN CATHETERS ARE MORE LIKELY TO BECOME INFECTED THAN SUBCLAVIAN OR INTERNAL JUGULAR VEIN CATHETERS, AND MULTILUMEN CATHETERS MAY ALSO HAVE A HIGHER RATE OF INFECTION THAN SINGLE LUMEN CATHETERS, BUT THIS MAY NOT BE CLINICALLY SIGNIFICANT SINCE MULTILUMEN CATHETERS ARE TYPICALLY USED FOR SHORT PERIODS OF TIME." PROVIDED IN SUPPLEMENT 1, IS NO LONGER APPLICABLE TO THIS INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED TO PROVIDE ADDITIONAL INFORMATION IN B.5, H.6, AND H.10. INVESTIGATION: A DISPOSABLES COMPLAINT HISTORY SEARCH FOR LOT 2003193130 AND FOUND NO OTHER REPORTS OF BACTERIAL CONTAMINATION. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THIS UNIT SHOWED NO IRREGULARITIES DURING MANUFACTURING THAT WERE RELEVANT TO THIS ISSUE. THE CUSTOMER TESTED A SET FROM THE BOX THAT STAFF HAD BEEN USING (SAME LOT NUMBER) AND RESULTS CAME BACK NEGATIVE FOR ANY GROWTH. FEMORAL VEIN CATHETERS ARE MORE LIKELY TO BECOME INFECTED THAN SUBCLAVIAN OR INTERNAL JUGULAR VEIN CATHETERS, AND MULTILUMEN CATHETERS MAY ALSO HAVE A HIGHER RATE OF INFECTION THAN SINGLE LUMEN CATHETERS, BUT THIS MAY NOT BE CLINICALLY SIGNIFICANT SINCE MULTILUMEN CATHETERS ARE TYPICALLY USED FOR SHORT PERIODS OF TIME. SOURCE: BULLARD KM, DUNN DL. BLOODSTREAM AND INTRAVASCULAR CATHETER INFECTIONS. IN: HOLZHEIMER RG, MANNICK JA, EDITORS. SURGICAL TREATMENT: EVIDENCE-BASED AND PROBLEM-ORIENTED. MUNICH: ZUCKSCHWERDT; 2001. AVAILABLE FROM: HTTPS://WWW.NCBI.NLM.NIH.GOV/BOOKS/NBK7008/. PER INTERNAL STERILITY 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. INVESTIGATION IS IN PROCESS. A FOLLOW UP REPORT WILL BE PROVIDED.

    Description of Event or Problem · 0

    THE CUSTOMER DECLINED TO PROVIDE THE PATIENT IDENTIFIER.

    Additional Manufacturer Narrative · 1

    INVESTIGATION: THE CUSTOMER TESTED A SET FROM THE SAME BOX AND IT CAME BACK NEGATIVE FOR ANY GROWTH. THE CHILD HAD 5 DAYS OF ANTIBIOTICS AND WAS COLLECTED AGAIN WITH NO GROWTH IN THE PRODUCT BAG. ONE THEORY, PER THE CUSTOMER, IS THAT THE CHILD HAD A SMALL BLOOD LEVEL OF ECOLI THAT DID NOT GROW ON CULTURE, HOWEVER WHEN CELLS WERE COLLECTED IN A SMALL CONCENTRATED LEVEL (5ML PER BOTTLE) THE E.COLI WAS DETECTED. INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY COLLECTED MONONUCLEAR CELL (MNC) PRODUCTS ON A PATIENT THREE SEPARATE TIMES, AND ALL THREE PRODUCTS TESTED POSITIVE FOR E. COLI. ALL THREE PRODUCTS WERE COLLECTED FROM KITS THAT WERE IN THE SAME BOX. THE FIRST TWO COLLECTIONS WERE DONE ON THE PATIENT USING A FEMORAL LINE. THE FEMORAL LINE WAS REMOVED AND A JUGULAR LINE WAS PLACED FOR THE THIRD COLLECTION. THE FEMORAL LINE TIP WAS NOT TESTED WHEN IT WAS REMOVED. PER THE CUSTOMER, THERE WAS NOTHING UNUSUAL ABOUT THE PROCEDURE. THIS REPORT IS BEING FILED FOR THE FIRST OF THREE PROCEDURES. THE PATIENT WAS PUT ON MEROPENEM ON THE SECOND DAY COLLECTION. PATIENT IDENTIFIER IS NOT AVAILABLE AT THIS TIME. THE DISPOSABLE SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387041 SPECTRA OPTIA SPECTRA OPTIA COLLECT SET GKT TERUMO BCT 12120 2003193130 05020583121201

    Patients

    Seq Age Sex Outcome Treatment
    1 00007 YR Other