MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA PLATELET+SAMPLER, PLASMA, RBC SET

Catalog Number 82446

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 07/12/2023

Event Type  Injury  

Event Description

An investigation was conducted for a maude report involving a 72-year-old male patient with a history of aml and thrombocytopenia, who experienced a serious adverse event of suspected transfusion transmitted b.Cereus following the transfusion of one of a double platelet product collected on a trima and subsequently treated with intercept.Patient id and weight are unknown and not provided in the report.The donor of the implicated unit was a 61-year-old, male with no history of positive bacterial detection with platelet donation.He donated a double apheresis platelet and a single apheresis plasma component the disposables set is not available for return because it was discarded by the customer.

Manufacturer Narrative

Investigation: according to cerus medical reviewer assessment, ¿the causality was assessed as possible in relation to the transfused intercept pc, although other causes cannot be definitively ruled out.The patient developed multiple signs and symptoms suggestive of a transfusion reaction with fever being the most prominent, one cannot definitively conclude this is due to b.Cereus infection because the patient never became hypotensive, and the first blood culture taken on the same date as the transfusion reaction was negative.The documented signs and symptoms immediately post-transfusion are more suggestive of underlying disease and/or febrile non-hemolytic transfusion reaction.While we recognize that the subsequent two negative blood cultures could be the effect of the patient being on antibiotic, this should still be considered as circumstantial evidence against b.Cereus infection.¿ the maude report indicated that the disposable lot number was not available.All lots must meet acceptance criteria for release.A review of the device history record (dhr) for this acda (lot #23063010) showed no irregularities during manufacturing that were relevant to this issue.The product was not available for return since it was transferred to another platelet processing set manufactured by cerus (lot#: ce23a19l71) for intercept treatment.Therefore, an evaluation could not be conducted as part of the investigation, they performed skin swabs from the antecubital area of the donor arm, swab samples of external storage location, manufacturing site and have ongoing hygiene monitoring of blood donation center, manufacturing site and laboratory.There were no reports of b.Cereus contamination in the last 3 years.Per literature review, bacillus cereus (b.Cereus) is classified as a gram-positive, aerobic or facultative anaerobic, spore former, motile, pathogenic, and opportunistic bacterium capable of producing resistant endospores in the presence of oxygen.B.Cereus is widely distributed in the environment, namely soil, where spores persist under adverse conditions.B.Cereus can grow over a wide temperature range (8¿55 °c), but it is not well suited to tolerate low ph values (minimum 5¿6) or water content (minimum water activity 0.95).B.Cereus endospores are resistant to heat, radiation, disinfectants, and desiccation, and their adhesive characters facilitate their attachment to processing equipment and resistance to cleaning procedures.These organisms frequently contaminate clinical environments, biotechnological processes, and food production (francis a.Drobniewski, bacillus cereus and related species.Clinical microbiology reviews, oct.1993, p.324-338).Per internal technical report, the phenomenon of bacterial contamination in blood products, especially platelets, is known to occur.With current technologies, given the nature of microorganisms on human skin and the mechanical act of piercing the skin coupled with the fact that platelets must be incubated at room temperature it is not possible to eliminate this phenomenon from occurring.The devices terumo bct manufactures to collect, separate and store blood products are terminally sterilized to an sal of < 1.0 x 10-6.Additionally, a sterility assurance system has been designed and employed to ensure this sal will be achieved for every product manufactured.Therefore, it may be concluded bacterial contamination observed in collected blood products from terumo bct devices is most likely due to the inherit hazard of collecting blood as it relates to bacterial contamination.According to the aabb circular of information for the use of human blood components (revised 2017), febrile nonhemolytic reactions are typically manifested by a temperature elevation of >1c or 2f occurring during or within 4 hours after a transfusion and in the absence of any other pyrexic stimulus or active warming.Febrile reactions may occur in less than 1% of transfusion of leukocyte-reduced red cell components and about 5% of leukocyte-reduced apheresis platelet components.Febrile reactions occur more frequently in patients receiving non-leukocyte-reduced components and those previously alloimunized by transfusion or pregnancy.Antipyretics usually provide effective symptomatic relief.Patients who experience repeated, severe febrile reactions may benefit from receiving leukocyte-reduced components.If these reactions are caused by cytokines in the component, prestorage leukocyte reduction may be beneficial investigation is in process, a follow-up report will be provided.

Manufacturer Narrative

Investigation: according to cerus medical reviewer assessment, the causality was assessed as possible in relation to the transfused intercept pc, although other causes cannot be definitively ruled out.The patient developed multiple signs and symptoms suggestive of a transfusion reaction with fever being the most prominent, one cannot definitively conclude this is due to b.Cereus infection because the patient never became hypotensive, and the first blood culture taken on the same date as the transfusion reaction was negative.The documented signs and symptoms immediately post-transfusion are more suggestive of underlying disease and/or febrile non-hemolytic transfusion reaction.While we recognize that the subsequent two negative blood cultures could be the effect of the patient being on antibiotic, this should still be considered as circumstantial evidence against b.Cereus infection.The maude report indicated that the disposable lot number was no available.All lots must meet acceptance criteria for release.A review of the device history record (dhr) for this acda (lot #23063010) showed no irregularities during manufacturing that were relevant to this issue.The product was not available for return since it was transferred to another platelet processing set manufactured by cerus (lot#: ce23a19l71) for intercept treatment.Therefore, an evaluation could not be conducted as part of the investigation, they performed skin swabs from the antecubital area of the donor arm, swab samples of external storage location, manufacturing site and have ongoing hygiene monitoring of blood donation center, manufacturing site and laboratory.There were no reports of b.Cereus contamination in the last 3 years.Per literature review, bacillus cereus (b.Cereus) is classified as a gram-positive, aerobic or facultative anaerobic, spore former, motile, pathogenic, and opportunistic bacterium capable of producing resistant endospores in the presence of oxygen.B.Cereus is widely distributed in the environment, namely soil, where spores persist under adverse conditions.B.Cereus can grow over a wide temperature range (8¿¿¿55 ¿¿c), but it is not well suited to tolerate low ph values (minimum 5¿¿¿6) or water content (minimum water activity 0.95).B.Cereus endospores are resistant to heat, radiation, disinfectants, and desiccation, and their adhesive characters facilitate their attachment to processing equipment and resistance to cleaning procedures.These organisms frequently contaminate clinical environments, biotechnological processes, and food production (francis a.Drobniewski, bacillus cereus and related species.Clinical microbiology reviews, oct.1993, p.324-338).Per internal technical report, the phenomenon of bacterial contamination in blood products, especially platelets, is known to occur.With current technologies, given the nature of microorganisms on human skin and the mechanical act of piercing the skin coupled with the fact that platelets must be incubated at room temperature it is not possible to eliminate this phenomenon from occurring.The devices terumo bct manufactures to collect, separate and store blood products are terminally sterilized to an sal of 1.0 x 10-6.Additionally, a sterility assurance system has been designed and employed to ensure this sal will be achieved for every product manufactured.Therefore, it may be concluded bacterial contamination observed in collected blood products from terumo bct devices is most likely due to the inherit hazard of collecting blood as it relates to bacterial contamination.According to the aabb circular of information for the use of human blood components (revised 2017), febrile nonhemolytic reactions are typically manifested by a temperature elevation of 1c or 2f occurring during or within 4 hours after a transfusion and in the absence of any other pyrexic stimulus or active warming.Febrile reactions may occur in less than 1% of transfusion of leukocyte-reduced red cell components and about 5% of leukocyte-reduced apheresis platelet components.Febrile reactions occur more frequently in patients receiving non-leukocyte-reduced components and those previously alloimunized by transfusion or pregnancy.Antipyretics usually provide effective symptomatic relief.Patients who experience repeated, severe febrile reactions may benefit from receiving leukocyte-reduced components.If these reactions are caused by cytokines in the component, prestorage leukocyte reduction may be beneficial root cause: according to cerus medical reviewer assessment, the causality was assessed as possible in relation to the transfused intercept pc, although other causes cannot be definitively ruled out.The patient developed multiple signs and symptoms suggestive of a transfusion reaction with fever being the most prominent, one cannot definitively conclude this is due to b.Cereus infection because the patient never became hypotensive, and the first blood culture taken on the same date as the transfusion reaction was negative.The documented signs and symptoms immediately post-transfusion are more suggestive of underlying disease and/or febrile non-hemolytic transfusion reaction.While we recognize that the subsequent two negative blood cultures could be the effect of the patient being on antibiotic, this should still be considered as circumstantial evidence against b.Cereus infection.A root cause assessment was performed for the transfusion reaction.Based on the available information a definitive root cause could not be determined but it is likely due to one or a combination of the possible causes listed below: * receiving a unit of platelet product that was contaminated with b.Cereus.* it is likely the reactions were caused by the presence of recipient antibodies (raised as a result of previous transfusions) reacting to donor human leucocyte antigens (hla) or other antigens.It is also widely known that febrile reactions are caused by passively transfused cytokines or recipient antibodies reacting with leukocytes in the blood product.A root cause assessment was performed for the microbial contamination.Based on the available information a definitive root cause could not be determined but it is likely due to one or a combination of the possible causes listed below: * improper venipuncture technique introduces bacteria at access site resulting in bacterial growth in product bag.* inadequate or no blood diversion performed due to operator error resulting in bacterial contamination of product.* species was endogenous and originated from the donor.* improper handling post collection.

Event Description

An investigation was conducted for a maude report involving a 72-year-old male patient with a history of aml and thrombocytopenia, who experienced a serious adverse event of suspected transfusion transmitted b.Cereus following the transfusion of one of a double platelet product collected on a trima and subsequently treated with intercept.Patient id and weight are unknown and not provided in the report.The donor of the implicated unit was a 61-year-old, male with no history of positive bacterial detection with platelet donation.He donated a double apheresis platelet and a single apheresis plasma component the disposables set is not available for return because it was discarded by the customer.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA PLATELET+SAMPLER, PLASMA, RBC SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer (Section G): TERUMO BCT; 10810 w. collins ave; lakewood CO 80215
• Manufacturer Contact: scot hilden ; 10810 w. collins ave; lakewood, CO 80215
• MDR Report Key: 18221062
• MDR Text Key: 329161875
• Report Number: 1722028-2023-00395
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: BK190332
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 82446
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/06/2023
• Initial Date FDA Received: 11/28/2023
• Supplement Dates Manufacturer Received: 12/11/2023
• Supplement Dates FDA Received: 12/18/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 72 YR
• Patient Sex: Male