SPECTRA OPTIA
Report
- Report Number
- 1722028-2025-00061
- Event Type
- Malfunction
- Date Received
- March 19, 2025
- Date of Event
- February 17, 2025
- Report Date
- March 19, 2025
- Manufacturer
- TERUMO BCT
- Product Code
- LKN
- UDI-DI
- 05020583122208
- PMA / PMN Number
- K183081
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IS
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THIS REPORT IS BEING FILED TO PROVIDE ADDITIONAL INFORMATION IN D.9, H.3, H.6 AND H.11 AND UPDATED INFORMATION IN B.5. INVESTIGATION: A COMPLETE BOX OF SIX (6) UNUSED SPECTRA OPTIA DISPOSABLE SETS WAS RECEIVED FOR INVESTIGATION. MINOR COSMETIC DAMAGE WAS NOTED ON THE TOP OF THE CARDBOARD BOX, THE DAMAGE DID NOT EXTEND THROUGH THE CARDBOARD. EACH KIT WAS INSPECTED, NO DAMAGE TO THE TYVEK WAS NOTED AND NO SIGNIFICANT DENTS IN THE TRAYS OBSERVED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THIS LOT SHOWED NO IRREGULARITIES DURING MANUFACTURING THAT WERE RELEVANT TO THIS ISSUE. INVESTIGATION IS IN PROCESS; A FOLLOW-UP REPORT WILL BE PROVIDED.
THIS REPORT IS BEING FILED TO PROVIDE ADDITIONAL INFORMATION IN D.4, H.6 AND H.11. INVESTIGATION: A COMPLETE BOX OF SIX (6) UNUSED SPECTRA OPTIA DISPOSABLE SETS WAS RECEIVED FOR INVESTIGATION. MINOR COSMETIC DAMAGE WAS NOTED ON THE TOP OF THE CARDBOARD BOX, THE DAMAGE DID NOT EXTEND THROUGH THE CARDBOARD. EACH KIT WAS INSPECTED, NO DAMAGE TO THE TYVEK WAS NOTED AND NO SIGNIFICANT DENTS IN THE TRAYS OBSERVED. TWO OF THE TYVEK LIDSTOCKS WERE OPENED, AND THE DISPOSABLE SETS VISUALLY INSPECTED, THERE WERE NO IDENTIFIABLE MISSING PARTS, MISASSEMBLIES OR TEARS WHICH COULD HAVE COMPROMISED THE INTEGRITY OF THE DISPOSABLE SETS. THERE WAS NO OBSERVABLE CONTAMINATION (DIRT/MOLD) IN THE TRAYS AND/OR THE SURFACE OF KITS. IT WAS ALSO NOTED THAN A CHEMICAL SMELL WAS NOT OBSERVED WHEN OPENING THE KITS. A PHOTO WAS ALSO SUBMITTED TO AID THE INVESTIGATION. THE IMAGE CAPTURED THE RECEIVED, AND UNOPENED SPECTRA OPTIA SHIPMENT, SITTING IN THE DESIGNATED WAREHOUSE. THE UNOPENED BOXES WERE STACKED UPON THEIR CORRESPONDING PALLETS. VISUAL OBSERVATION CONFIRMED THAT THE PACKAGING WAS INTACT, AND NO OBVIOUS DAMAGE WAS APPARENT TO THE SHIPMENT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THIS LOT SHOWED NO IRREGULARITIES DURING MANUFACTURING THAT WERE RELEVANT TO THIS ISSUE. A DISPOSABLE COMPLAINT HISTORY SEARCH WAS PERFORMED FOR THIS LOT AND FOUND ZERO FURTHER REPORTS FOR A SIMILAR ISSUE ON THIS LOT. THE DHR REVIEW CONFIRMS THAT ETO AERATION AND STERILIZATION MET RELEASE CRITERIA. AS SUCH, A LITERATURE REVIEW WAS PERFORMED FOR ALL THE ORGANISMS WHOSE GROWTH WAS SUPPORTED BY THE TSB MEDIUM. BACILLUS SUBTILIS IS A GRAM-POSITIVE ROD-SHAPED BACTERIUM FOUND LARGELY IN SOIL AND DECOMPOSING PLANT MATERIAL AND IS ESSENTIAL IN THE DEGRADATION OF WASTE PRODUCTS. THIS SPORE-FORMING PATHOGEN IS A FACULTATIVE AEROBE AND HAS AN OPTIMAL GROWTH TEMPERATURE RANGING FROM 25°C TO 35°C. THE BACTERIUM IS CONSIDERED NON-PATHOGENIC TO HUMANS. BACILLUS SUBTILIS (B. SUBTILIS) IS A TYPE OF PROBIOTIC ("GOOD" BACTERIA) FOUND NATURALLY IN THE HUMAN GUT. (1)(2) HOWEVER, B. SUBTILIS CAN CAUSE SECONDARY NOSOCOMIAL INFECTIONS IN IMMUNOCOMPROMISED PATIENTS WHICH MAY BE LETHAL. BACILLUS SUBTILIS SECRETES TISSUE-DAMAGING TOXINS AND ENZYMES SUCH AS PENICILLINASE, WHICH INACTIVATE PENICILLIN, THEREBY INTERFERING WITH CERTAIN PENICILLIN-BASED ANTIBIOTIC TREATMENTS. (1) BACILLUS SUBTILIS HAS ALSO BEEN IMPLICATED IN FOOD-BORNE ILLNESSES SUCH AS VOMITING WITH ACCOMPANYING DIARRHEA. CANDIDA ALBICANS IS COMMONLY FOUND AS PART OF THE NORMAL HUMAN MICROBIOME, PARTICULARLY IN THE GASTROINTESTINAL TRACT, GENITOURINARY TRACT, AND ON THE SKIN. IT'S A HARMLESS COMMENSAL FUNGUS, MEANING IT LIVES IN SYMBIOSIS WITH THE HOST WITHOUT CAUSING HARM IN MOST INDIVIDUALS. HOWEVER, CANDIDIASIS IS AN OPPORTUNISTIC INFECTION WHICH OCCURS MOST COMMONLY AS A SECONDARY INFECTION IN IMMUNOCOMPROMISED INDIVIDUALS. CANDIDA ALBICANS IS PRESENT IN HEALTHY PERSONS COLONIZING THE OROPHARYNGEAL, ESOPHAGEAL, AND GASTROINTESTINAL MUCOSA. THEY BECOME PATHOGENIC ONLY WHEN FAVORABLE CONDITIONS ARISE. CANDIDA ALBICANS CAN CAUSE MUCOSAL CANDIDIASIS IN THESE AREAS WHERE THEY USUALLY ARE PRESENT IN AN IMMUNOCOMPROMISED HOST. IN PATIENTS WHO HAVE LEUKEMIA, LYMPHOMA BECAUSE OF THE CONSUMPTION OF CORTICOSTEROIDS OR CYTOTOXIC DRUGS, THEIR IMMUNITY IS COMPROMISED, LEADING TO CANDIDAL INFECTION. (3 ,4) THERE ARE THREE MAJOR ROUTES BY WHICH CANDIDA REACHES THE BLOODSTREAM: THE MOST FREQUENT ROUTE IS VIA THE GASTROINTESTINAL TRACT MUCOSAL BARRIER, OTHERS BEING THROUGH AN INTRAVASCULAR CATHETER AND FROM A LOCALIZED INFECTION. CANDIDA CAN PASS INTO THE BLOODSTREAM IN NEUTROPENIC PATIENTS AS WELL AS IN INTENSIVE CARE UNIT PATIENTS. THEY ARE ALSO A PART OF THE NORMAL GUT MICROFLORA, AND ANY CONDITION THAT MAY MAKE A PERSON IMMUNOCOMPROMISED CAN LEAD TO CANDIDIASIS IN THE BLOODSTREAM. (3) THERE ARE OVER 200 NAMED SPECIES OF ASPERGILLUS. ASPERGILLUS NIGER IS PART OF A GROUP OF SPECIES NAMED ASPERGILLUS SECTION NIGRI. A. NIGER IS COSMOPOLITAN AND OF VERY COMMON OCCURRENCE: IT GROWS AEROBICALLY ON ORGANIC MATTER. THIS SPECIES IS A COMMON CONTAMINANT ON VARIOUS SUBSTRATES, FOUND IN SOIL AND LITTER, IN COMPOST AND ON DECAYING PLANT MATERIAL; IT CAN EVEN BE FOUND IN ICY ENVIRONMENTS AND MARINE ENVIRONMENTS, BUT USUALLY PREFERS DRY AND WARM SOILS. (5) IT IS OFTEN ISOLATED FROM HOUSE DUST, SOIL, DRIED NUTS, FRUITS AND SEEDS AS WELL AS VARIOUS TYPES OF UNTREATED TEXTILE MATERIALS SUCH AS JUTE HEMP AND COTTON BRACTS; HENCE, THE OFTEN ABUNDANT PRESENCE OF THIS SPECIES IN THE TEXTILE INDUSTRY. A. NIGER CAN ALSO CONTAMINATE MEAT AND EGGS, CAUSING PROGRESSIVE SPOILAGE EVEN THOUGH IT IS CONSIDERED AN UBIQUITOUS INNOCUOUS CONTAMINANT, ASPERGILLUS NIGER CAN, IN SPECIAL RARE CIRCUMSTANCES, CAUSE OPPORTUNISTIC HUMAN DISEASES. A. NIGER IS A MESOPHILIC FUNGUS: ITS OPTIMAL GROWTH TEMPERATURE IS 20-40 °C, WITH GOOD GROWTH AT 37 °C. A. NIGER CAN BE FOUND GROWING ON DAMP BUILDING MATERIALS AND IN CONTAMINATED VENTILATION SYSTEMS. IT IS ALSO FOUND AS AN AIRBORNE CONTAMINANT OF MANY BUILDINGS PROCESSING VEGETABLE MATTER OR PRODUCING COMMERCIALLY A. NIGER METABOLITES. (5) HUMAN INFECTIONS BY ASPERGILLUS NIGER ARE RARE. IN FACT, A. NIGER IS GENERALLY REGARDED AS A NON-PATHOGENIC FUNGUS; SPORE INHALATION IS COMMON BUT DISEASE IN HEALTHY SUBJECTS IS QUITE UNCOMMON. HOWEVER, OPPORTUNISTIC INFECTIONS IN IMMUNOCOMPROMISED PATIENTS, LEADING TO RESPIRATORY INFECTIONS, MYCOTIC KERATITIS AND ENDOCARDITIS HAVE BEEN OCCASIONALLY REPORTED. (5) AS SUCH, A LITERATURE REVIEW WAS PERFORMED FOR ALL THE ORGANISMS WHOSE GROWTH WAS SUPPORTED BY THE TSB MEDIUM. BACILLUS SUBTILIS IS A GRAM-POSITIVE ROD-SHAPED BACTERIUM FOUND LARGELY IN SOIL AND DECOMPOSING PLANT MATERIAL AND IS ESSENTIAL IN THE DEGRADATION OF WASTE PRODUCTS. THIS SPORE-FORMING PATHOGEN IS A FACULTATIVE AEROBE AND HAS AN OPTIMAL GROWTH TEMPERATURE RANGING FROM 25°C TO 35°C. THE BACTERIUM IS CONSIDERED NON-PATHOGENIC TO HUMANS. BACILLUS SUBTILIS (B. SUBTILIS) IS A TYPE OF PROBIOTIC ("GOOD" BACTERIA) FOUND NATURALLY IN THE HUMAN GUT. (1)(2) HOWEVER, B. SUBTILIS CAN CAUSE SECONDARY NOSOCOMIAL INFECTIONS IN IMMUNOCOMPROMISED PATIENTS WHICH MAY BE LETHAL. BACILLUS SUBTILIS SECRETES TISSUE-DAMAGING TOXINS AND ENZYMES SUCH AS PENICILLINASE, WHICH INACTIVATE PENICILLIN, THEREBY INTERFERING WITH CERTAIN PENICILLIN-BASED ANTIBIOTIC TREATMENTS. (1) BACILLUS SUBTILIS HAS ALSO BEEN IMPLICATED IN FOOD-BORNE ILLNESSES SUCH AS VOMITING WITH ACCOMPANYING DIARRHEA. CANDIDA ALBICANS IS COMMONLY FOUND AS PART OF THE NORMAL HUMAN MICROBIOME, PARTICULARLY IN THE GASTROINTESTINAL TRACT, GENITOURINARY TRACT, AND ON THE SKIN. IT'S A HARMLESS COMMENSAL FUNGUS, MEANING IT LIVES IN SYMBIOSIS WITH THE HOST WITHOUT CAUSING HARM IN MOST INDIVIDUALS. HOWEVER, CANDIDIASIS IS AN OPPORTUNISTIC INFECTION WHICH OCCURS MOST COMMONLY AS A SECONDARY INFECTION IN IMMUNOCOMPROMISED INDIVIDUALS. CANDIDA ALBICANS IS PRESENT IN HEALTHY PERSONS COLONIZING THE OROPHARYNGEAL, ESOPHAGEAL, AND GASTROINTESTINAL MUCOSA. THEY BECOME PATHOGENIC ONLY WHEN FAVORABLE CONDITIONS ARISE. CANDIDA ALBICANS CAN CAUSE MUCOSAL CANDIDIASIS IN THESE AREAS WHERE THEY USUALLY ARE PRESENT IN AN IMMUNOCOMPROMISED HOST. IN PATIENTS WHO HAVE LEUKEMIA, LYMPHOMA BECAUSE OF THE CONSUMPTION OF CORTICOSTEROIDS OR CYTOTOXIC DRUGS, THEIR IMMUNITY IS COMPROMISED, LEADING TO CANDIDAL INFECTION. (3 ,4) THERE ARE THREE MAJOR ROUTES BY WHICH CANDIDA REACHES THE BLOODSTREAM: THE MOST FREQUENT ROUTE IS VIA THE GASTROINTESTINAL TRACT MUCOSAL BARRIER, OTHERS BEING THROUGH AN INTRAVASCULAR CATHETER AND FROM A LOCALIZED INFECTION. CANDIDA CAN PASS INTO THE BLOODSTREAM IN NEUTROPENIC PATIENTS AS WELL AS IN INTENSIVE CARE UNIT PATIENTS. THEY ARE ALSO A PART OF THE NORMAL GUT MICROFLORA, AND ANY CONDITION THAT MAY MAKE A PERSON IMMUNOCOMPROMISED CAN LEAD TO CANDIDIASIS IN THE BLOODSTREAM. (3) THERE ARE OVER 200 NAMED SPECIES OF ASPERGILLUS. ASPERGILLUS NIGER IS PART OF A GROUP OF SPECIES NAMED ASPERGILLUS SECTION NIGRI. A. NIGER IS COSMOPOLITAN AND OF VERY COMMON OCCURRENCE: IT GROWS AEROBICALLY ON ORGANIC MATTER. THIS SPECIES IS A COMMON CONTAMINANT ON VARIOUS SUBSTRATES, FOUND IN SOIL AND LITTER, IN COMPOST AND ON DECAYING PLANT MATERIAL; IT CAN EVEN BE FOUND IN ICY ENVIRONMENTS AND MARINE ENVIRONMENTS, BUT USUALLY PREFERS DRY AND WARM SOILS. (5) IT IS OFTEN ISOLATED FROM HOUSE DUST, SOIL, DRIED NUTS, FRUITS AND SEEDS AS WELL AS VARIOUS TYPES OF UNTREATED TEXTILE MATERIALS SUCH AS JUTE HEMP AND COTTON BRACTS; HENCE, THE OFTEN ABUNDANT PRESENCE OF THIS SPECIES IN THE TEXTILE INDUSTRY. A. NIGER CAN ALSO CONTAMINATE MEAT AND EGGS, CAUSING PROGRESSIVE SPOILAGE EVEN THOUGH IT IS CONSIDERED AN UBIQUITOUS INNOCUOUS CONTAMINANT, ASPERGILLUS NIGER CAN, IN SPECIAL RARE CIRCUMSTANCES, CAUSE OPPORTUNISTIC HUMAN DISEASES. A. NIGER IS A MESOPHILIC FUNGUS: ITS OPTIMAL GROWTH TEMPERATURE IS 20-40 °C, WITH GOOD GROWTH AT 37 °C. A. NIGER CAN BE FOUND GROWING ON DAMP BUILDING MATERIALS AND IN CONTAMINATED VENTILATION SYSTEMS. IT IS ALSO FOUND AS AN AIRBORNE CONTAMINANT OF MANY BUILDINGS PROCESSING VEGETABLE MATTER OR PRODUCING COMMERCIALLY A. NIGER METABOLITES. (5) HUMAN INFECTIONS BY ASPERGILLUS NIGER ARE RARE. IN FACT, A. NIGER IS GENERALLY REGARDED AS A NON-PATHOGENIC FUNGUS; SPORE INHALATION IS COMMON BUT DISEASE IN HEALTHY SUBJECTS IS QUITE UNCOMMON. HOWEVER, OPPORTUNISTIC INFECTIONS IN IMMUNOCOMPROMISED PATIENTS, LEADING TO RESPIRATORY INFECTIONS, MYCOTIC KERATITIS AND ENDOCARDITIS HAVE BEEN OCCASIONALLY REPORTED. (5) REFERENCES: 1. CHASSAGNE F. MEDICINAL PLANTS AS ANTI-INFECTIVES: CURRENT KNOWLEDGE AND NEW PERSPECTIVES. ELSEVIER; 2022. 2. PROKARYOTAE R. ABIS ENCYCLOPEDIA [INTERNET]. AVAILABLE FROM: HTTPS://TGW1916.NET/BACILLUS/SUBTILIS.HTML 3. R AN, RAFIQ NB. CANDIDIASIS. [UPDATED 2023 MAY 29]. IN: STATPEARLS [INTERNET]. TREASURE ISLAND (FL): STATPEARLS PUBLISHING; 2025 JAN-. AVAILABLE FROM: HTTPS://WWW.NCBI.NLM.NIH.GOV/BOOKS/NBK560624/ 4. CANDIDA ALBICANS [INTERNET]. CLEVELAND CLINIC. 2025. AVAILABLE FROM: HTTPS://MY.CLEVELANDCLINIC.ORG/HEALTH/DISEASES/22961-CANDIDA-ALBICANS 5. ASPERGILLUS NIGER / INSPQ [INTERNET]. INSTITUT NATIONAL DE SANTÉ PUBLIQUE DU QUÉBEC. AVAILABLE FROM: HTTPS://WWW.INSPQ.QC.CA/EN/MOULDS/FACT-SHEETS/ASPERGILLUS-NIGER ROOT CAUSE: A ROOT CAUSE ASSESSMENT WAS PERFORMED FOR THE CHEMICAL SMELL AND REPORTED MICROBIAL CONTAMINATION. REGARDING THE CYCLOHEXANONE, CYCLOHEXANONE IS A COLOURLESS, OILY LIQUID WITH A SWEET ODOUR, A CYCLIC KETONE, AND A COMMON SOLVENT IN VARIOUS INDUSTRIES. CYCLOHEXANONE IS USED WITHIN OPTIA DISPOSABLE SETS FOR BONDING VARIOUS TUBING¿S AND/OR BOND SOCKETS. HOWEVER, THE CAUSE OF THE EXCESSIVE SMELL CANNOT BE DEFINITIVELY DETERMINED BUT IS MOST LIKELY DUE TO THE AMPLIFICATION OF THE CHEMICAL SMELL, CAUSED BY VARIOUS SHIPPING CONDITIONS. REGARDING THE MICROBIAL CONTAMINATION, THE EXACT TESTING METHOD IS UNKNOWN, SO IT CANNOT BE DEFINITIVELY DETERMINED WHERE THE PRODUCT WAS COLLECTED FROM. AS PER USP 71, DIRECT TRANSFER, IS PRIMARILY USED FOR MEDICAL DEVICES. THE MOST LIKELY ROOT CAUSE IS DUE TO FALSE POSITIVES CAUSED BY THE INITIAL SAMPLING TECHNIQUES/ASEPTIC SAMPLING TECHNIQUES. IT IS LIKELY THAT THE EXTERIOR OF THE DISPOSABLE SET WAS TESTED BY SUBMERGING THE SET IN TESTING MEDIUM AFTER EXPOSURE TO AIRBORNE OR NORMAL HUMAN MICROBIOMES, AND THAT OPTIA DISPOSABLE INTERNAL FLUID PATHWAY REMAINED SEALED AND WAS STERILE, AS CONFIRMED BY THE PART RETURN EVALUATION. IT IS ALSO POSSIBLE THAT THE STORAGE TEMPERATURES/CONDITIONS DURING SHIPMENT AND/OR STORAGE WERE OUTSIDE THE VALIDATED STORAGE EXCURSION RANGE, HOWEVER THIS CANNOT BE DEFINITIVELY DETERMINED.
INVESTIGATION IS IN PROCESS, A FOLLOW-UP REPORT WILL BE PROVIDED.
THE CUSTOMER REPORTED POSITIVE MICROBIOLOGICAL TEST RESULTS GROWTH ON TEST #1 OF AN UNUSED OPTIA DISPOSABLE SET. THERE WAS NOT A TRANSFUSION RECIPIENT OR PATIENT INVOLVED, THEREFORE NO PATIENT INFORMATION IS REASONABLY KNOWN AT THE TIME OF THE EVENT.
THE CUSTOMER REPORTED POSITIVE MICROBIOLOGICAL TEST RESULTS GROWTH ON TEST #1 OF AN UNUSED OPTIA DISPOSABLE SET. IT WAS REPORTED THAT THE OPTIA DISPOSABLE SET SEA SHIPMENT ARRIVED IN A BAD CONDITION. THE SHIPMENT ARRIVED AT THE DISTRIBUTOR IN A CLOSED CONTAINER, AND UPON OPENING IT IN THE DESIGNATED WAREHOUSE, A VERY CHEMICAL SMELL WAS NOTED. THE SMELL WAS SIGNIFICANT ENOUGH THAT IT MADE THE RECIPIENTS EXPERIENCE HEADACHES AND DIZZINESS, THE SMELL LASTED ON THE CARTONS FOR A COUPLE OF WEEKS. ALL SETS AND FILTERS WERE PLACED IN QUARANTINE. AIR ANALYSIS WAS INITIALLY PERFORMED THROUGH THE INSURANCE COMPANY, WHICH CONCLUDED THAT THE PRINCIPAL VOLATILE MATERIAL WAS CYCLOHEXANONE. SUBSEQUENT MICROBIAL TESTING WAS THEN PERFORMED ON KITS TAKEN AT RANDOM FROM THE DELIVERY. THE STERILITY OF THE SAMPLES WAS TESTED ACCORDING TO THE TEST PROCEDURES FOR STERILITY (USP 71) FOR MEDICAL DEVICES (IN THE FILTRATION METHOD). EACH "PRODUCT" WAS ASEPTICALLY TRANSFERRED INTO BAG CONTAINING A TOTAL OF 800 ML ELUENT (BPS 0.1 % TWEEN 80, BATCH NO. 3503). THE EXTRACTION WAS PERFORMED BY HAND MIXING FOR 60 SECONDS. AFTER EXTRACTION THE ELUENT WAS FILTERED (400 MLX2) THROUGH A 47 MM, 0.45 MEMBRANE FILTER. ONE FILTER WAS TRANSFERRED TO FLUID THIOGLYCOLLATE MEDIUM (BATCH NO. 3504) AND THE OTHER TO SOYBEAN CASEIN DIGEST MEDIUM (BATCH NO. 3504). THE TEST MIXTURES WERE INCUBATED AT 32.5+2.5°C AND 22.5+2.5°C RESPECTIVELY FOR 14 DAYS AND THEN CHECKED FOR TURBIDITY. THE THG MEDIUM OBSERVED NO GROWTH, HOWEVER THE TSB OBSERVED GROWTH. THE MICROORGANISMS IDENTIFIED WERE NOT REPORTED, HOWEVER THE TSB MEDIUM WAS TESTED FOR THEIR ABILITY TO SUPPORT THE GROWTH OF BACILLUS SUBTILIS, CANDIDA ALBICANS AND ASPERGILLUS NIGER, AND SUITABILITY WAS VERIFIED AS PER USP STANDARDS. IT IS UNKNOWN WHICH TECHNIQUE WAS EMPLOYED FOR THE MICROBIAL TESTING PERFORMED IN THIS COMPLAINT AND THEREFORE WHAT AREA WAS DETERMINED AS THE "PRODUCT". THERE WAS NOT A TRANSFUSION RECIPIENT OR PATIENT INVOLVED; THEREFORE, NO PATIENT INFORMATION IS REASONABLY KNOWN AT THE TIME OF THE EVENT.
THE CUSTOMER REPORTED POSITIVE MICROBIOLOGICAL TEST RESULTS GROWTH ON TEST #1 OF AN UNUSED OPTIA DISPOSABLE SET. TERUMO BCT IS AWAITING RETURN OF THE DISPOSABLE SET FOR EVALUATION. THERE WAS NOT A TRANSFUSION RECIPIENT OR PATIENT INVOLVED, THEREFORE NO PATIENT INFORMATION IS REASONABLY KNOWN AT THE TIME OF THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 688623 | SPECTRA OPTIA | SPECTRA OPTIA EXCHANGE SET | LKN | TERUMO BCT | 2408083141 | 05020583122208 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |