BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA OPTIA

    MDR report key: 10422295 · Received August 18, 2020

    Report

    Report Number
    1722028-2020-00398
    Event Type
    Injury
    Date Received
    August 18, 2020
    Date of Event
    July 27, 2015
    Report Date
    August 18, 2020
    Manufacturer
    TERUMO BCT
    Product Code
    LKN
    PMA / PMN Number
    K183081
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED TO PROVIDE ADDITIONAL INFORMATION IN E.1, H.6 AND H.10. INVESTIGATION: 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. 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. PER LITERATURE REVIEW, COAGULASE-NEGATIVE STAPHYLOCOCCI (CNS) ARE DIFFERENTIATED FROM THE CLOSELY RELATED BUT MORE VIRULENT STAPHYLOCOCCUS AUREUS BY THEIR INABILITY TO PRODUCE FREE COAGULASE. CURRENTLY, THERE ARE OVER 40 RECOGNIZED SPECIES OF CNS. THESE ORGANISMS TYPICALLY RESIDE ON HEALTHY HUMAN SKIN AND MUCUS MEMBRANES, RARELY CAUSE DISEASE, AND ARE MOST FREQUENTLY ENCOUNTERED BY CLINICIANS AS CONTAMINANTS OF MICROBIOLOGICAL CULTURES. HOWEVER, CNS HAVE BEEN INCREASINGLY RECOGNIZED TO CAUSE CLINICALLY SIGNIFICANT INFECTIONS. THE CONVERSION OF THE CNS FROM SYMBIONT TO HUMAN PATHOGEN HAS BEEN A DIRECT REFLECTION OF THE USE OF INDWELLING MEDICAL DEVICES (SOURCE: COAGULASE-NEGATIVE STAPHYLOCOCCAL INFECTIONS KATHIE L. ROGERS, PHD, PAUL D. FEY, PHD, MARK E. RUPP, MD. INFECT DIS CLIN N AM 23 (2009) 73¿98 . PER LITERATURE REVIEW, MICROCOCCUS LUTEUS IS A WIDESPREAD GRAM-POSITIVE NON-MOTILE AEROBIC COCCUS OF ACTINOBACTERIA PHYLUM, WHICH IS ENCOUNTERED IN SOIL, WATER, HUMAN SKIN (I.E. STRATUM CORNEUM AND HAIR FOLLICLES). M. LUTEUS IS AN IMPORTANT PART OF HUMAN SKIN MICROBIOTA, WHICH FORMS COMMUNITIES WITH OTHER SKIN COMMENSALS [EVELINA L. ZDOROVENKO ET AL. STRUCTURE OF CELL-WALL GLYCOPOLYMERS OF MICROCOCCUS LUTEUS C01. CARBOHYDRATE RESEARCH 506 (2021) 108356 MAY 2021. PER LITERATURE REVIEW, ACINETOBACTER IWOFFII IS AN AEROBIC NON-FERMENTATIVE GRAM-NEGATIVE BACILLUS OF LOW VIRULENCE THAT IS UBIQUITOUS IN NATURE. IT IS CONSIDERED AS NORMAL FLORA THAT INHABITS THE OROPHARYNX, SKIN AND THE PERINEUM OF HEALTHY INDIVIDUALS [NIRAV MEHTA, CHINMAY PATEL, HITESH H. SHAH, HOFSTRA NORTH SHORE-LIJ SCHOOL OF MEDICINE, GREAT NECK, NY, USA. ACINETOBACTER IWOFFII PERITONITIS IN A PATIENT ON AUTOMATED PERITONEAL DIALYSIS. AM J KIDNEY DIS. 2014;63(5):A1-A121. ROOT CAUSE: A DEFINITIVE ROOT CAUSE FOR PATIENT DEATHS COULD NOT BE DETERMINED BUT IS LIKELY RELATED TO PRE-EXISTING DISEASE STATE. A DEFINITIVE ROOT CAUSE FOR PATIENT REACTIONS COULD NOT BE DETERMINED. POSSIBLE CAUSES FOR THE ALLEGED VASOVAGAL REACTIONS INCLUDE BUT ARE NOT LIMITED TO PATIENT DISEASE STATE AND/OR PATIENT SENSITIVITY TO THE PROCEDURE.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED TO PROVIDE ADDITIONAL INFORMATION IN B5 AND H10. INVESTIGATION: THERE IS NO EVIDENCE TO INDICATE THAT THE SPECTRA OPTIA DEVICE CAUSED OR CONTRIBUTED TO THE DEATHS OF 3 PATIENTS. DHR DETAILS: SINCE THIS WAS A RETROSPECTIVE STUDY BETWEEN (B)(6) 2011 AND (B)(6) 2014, THE LOT NUMBERS ARE UNKNOWN; THEREFORE, DHR SEARCHES COULD NOT BE CONDUCTED FOR THE REPORTED INCIDENTS. ALL LOTS MUST MEET ACCEPTANCE CRITERIA FOR RELEASE. INVESTIGATION IS IN PROCESS. A FOLLOW UP REPORT WILL BE PROVIDED.

    Description of Event or Problem · 0

    TWENTY-SEVEN PATIENTS WERE MALE AND 23 FEMALE WITH A MEAN AGE OF 38 (RANGE 19¿58). THIS WAS A RETROSPECTIVE STUDY BETWEEN (B)(6) 2011 AND (B)(6) 2014 TO ASSESS THE EFFICACY OF REGULAR AUTOMATED RED CELL EXCHANGE TRANSFUSION IN THE MANAGEMENT OF SICKLE CELL DISEASE. A REQUEST FOR SPECIFIC PATIENT INFORMATION IS NOT FEASIBLE.

    Additional Manufacturer Narrative · 1

    LOT NUMBER AND EXPIRY INFORMATION ARE NOT AVAILABLE AT THIS TIME. ARTICLE CITATION: TSITSIKAS, DA, ET AL. 2016. SAFETY, TOLERABILITY, AND OUTCOMES OF REGULAR AUTOMATED RED CELL EXCHANGE TRANSFUSION IN THE MANAGEMENT OF SICKLE CELL DISEASE. JOURNAL OF CLINICAL APHERESIS. 2016; 31:545¿550. INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED. THIS REPORT WAS FILED BEYOND THE 30-DAY TIMEFRAME DUE TO AN INTERNAL PROCESSING ERROR. AN INTERNAL CAPA HAS BEEN INITIATED TO ADDRESS THE ISSUE. [(B)(4)].

    Description of Event or Problem · 1

    THE ARTICLE, 'SAFETY, TOLERABILITY, AND OUTCOMES OF REGULAR AUTOMATED RED CELL EXCHANGE TRANSFUSION IN THE MANAGEMENT OF SICKLE CELL DISEASE' (TSITSIKAS 2016) DESCRIBES 50 PATIENTS WHO UNDERWENT 504 REGULAR AUTOMATED RED BLOOD CELL EXCHANGE (RBCX) PROCEDURES WITH SPECTRA OPTIA. TWENTY-SEVEN PATIENTS WERE MALE AND 23 FEMALE WITH A MEAN AGE OF 38 (19¿58). DURING THE STUDY, THE MEAN PRE-TRANSFUSION PLATELET (PLT) COUNT WAS 352 X 10^9/L (65¿765) AND THE MEAN POST- TRANSFUSION PLT COUNT WAS 106 X 10^9/L (19¿593) REPRESENTING A 70% REDUCTION. OF NOTE, THE POST-TRANSFUSION PLT COUNT WAS <100 X 10^9/L AND <50 X 109/L (DESCRIBED AS SEVERE THROMBOCYTOPENIA) ON 49% (247 PROCEDURES) AND 6% OF PROCEDURES (30 PROCEDURES), RESPECTIVELY. THREE OF THE 50 (6%) PATIENTS DEVELOPED A TOTAL OF FOUR NEW ANTIBODIES WHILE ON REGULAR AUTOMATED RBCX PROCEDURES REPRESENTING A RATE OF FORMATION OF NEW ANTIBODIES OF 0.065/100 UNITS OF RED CELLS. PER THE ARTICLE, THREE OF THE PATIENTS INVOLVED IN THE STUDY DIED. SPECIFIC DETAILS, SUCH AS PATIENT INFORMATION AND CAUSE OF DEATH, WERE NOT INCLUDED IN THE ARTICLE FOR THESE EVENTS, THEREFORE THIS REPORT IS BEING PROVIDED AS A SUMMARY OF THE EVENTS. THIS REPORT IS BEING FILED DUE TO PATIENT DEATH, THOUGH AT THIS TIME, THERE IS NO ALLEGATION THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE DEATHS. 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
    883178 SPECTRA OPTIA SPECTRA OPTIA EXCHANGE SET LKN TERUMO BCT

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| O