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

Catalog Number 5803002

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

Patient Problem Fever (1858)

Event Date 07/20/2023

Event Type  malfunction  

Manufacturer Narrative

Investigation: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue investigation is in process, a follow-up report will be provided.

Event Description

The customer reported that one bag of trima collected platelets was infused to a patient and when preparing to infuse another bag they noticed serious aggregation.The product was returned to the blood center and they verified collection, handover, storage and handout of the platelets were all normal.The blood center performed tests and found a positive bacterial culture of staphylococcus aureus.It was reported that the patient had a fever.The patient's condition is normal.The customer declined to provide further procedural details and patient information.The collection set is not available for return because it was discarded by the customer.

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h.10.Investigation: in lieu of the disposable set, the customer supplied multiple images to aid the investigation.The first two images captured the platelet bag containing platelet fluid.Aggregation can be confirmed within the product bags.The final image captured the product qc data for the transfused platelets.The product was returned to the blood center and the processes of collection, handover, storage and hand out were checked and all confirmed to be normal.Testing on the returned platelet confirmed a ph of 5.31 which is indicative of platelet necrosis, no swirl would have been observed on the platelet product.The patient developed a fever that afternoon with appeared diminution of vision.The present status was not available.The customer declined to provide more details relating to the patient status and if medical intervention was required.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue a literature review was conducted for the organism identified by the customer.Per literature review, staphylococcus aureus is a major bacterial human pathogen that causes a wide variety of clinical manifestations.Staphylococcus aureus is a gram-positive bacteria that can cause a wide variety of clinical diseases.Infections caused by this pathogen are common both in community-acquired and hospital-acquired settings.S.Aureus is found in the environment and is also found in normal human flora, located on the skin and mucous membranes (most often the nasal area) of most healthy individuals.S.Aureus does not normally cause infection on healthy skin; however, if it is allowed to enter the bloodstream or internal tissues, these bacteria may cause a variety of potentially serious infections.Transmission is typically from direct contact by touching infected blood or body fluids, most often by contaminated hands.Certain groups of people are more at risk than others to develop a serious s.Aureus infection; this includes people with conditions such as: diabetes, cancer, vascular disease, patients who are hospitalized in intensive care units (icus), patients who have undergone certain types of surgeries, and patients with medical devices inserted in their bodies, such as central lines and catheters.Staphylococcus aureus is a gram-positive bacteria (stain purple by gram stain) that are cocci-shaped and tend to be arranged in clusters that are described as ¿grape-like.¿ on media, these organisms can grow in up to 10% salt, and colonies are often golden or yellow (aureus means golden or yellow).These organisms can grow aerobically or anaerobically (facultative) and at temperatures between 18 c and 40 c.Park, j.Y., seo, k.S., 2022.Food microbiology: fundamentals and frontiers 555¿584.Staphylococcus aureus - apic [www document], n.D.Url https://apic.Org/monthly_alerts/staphylococcus-aureus/ (accessed 5.18.23).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 in lakewood / littleton, co, vietnam, costa rica and harmac 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.A disposable complaint history search was performed for this lot and found no other reports for similar issues on this lot.Root cause: a root cause assessment was performed for the microbial contamination identified by the customer.Based on the available information it is likely that the hospital unknowingly transfused a contaminated platelet product to the patient, resulting in the patient reactions reported.However, this cannot be definitively determined.The root cause of the confirmed microbial contamination also cannot be definitively determined, however is likely due to one or a combination of the possible causes listed below: * the species was endogenous and originated from the donor.* improper venipuncture technique introduced bacteria at access site resulting in bacterial growth in product bag.* improper venipuncture technique and no blood diversion performed due to operator error resulting in bacterial contamination of product.* improper maintenance of the central line.A root cause assessment was also performed for the platelet aggregation identified during the picture evaluation.Based on the available information an exact root cause cannot be definitively determined.It is likely that the bacterial contamination caused the aggregates identified.If transfused, the aggregates observed would have likely been caught in the transfusion filter and not transfused to the patient.The likelihood for platelet clumping to occur during a run is difficult to predict since it is not dependent on a specific platelet count and varies by patient.Therefore, every procedure should be observed for clumping in the connector.The following are further possible causes of aggregation which could not be ruled out and include: inadequate anticoagulation resulting in platelet aggregation in the extracorporeal circuit and collected product.Excessive pasting due to donor physiology.Incorrect entry of patient data including hct and platelet counts, poor access resulting in pump pauses, incomplete loading of the disposable set causing an occlusion in the tubing and/or an air block, which restricted the flow, patient's blood physiology interferes with separation of cellular components.Rbc detector contained an air bubble, improper resting or agitation of product.Platelet bag storage conditions that do not follow the manufacturer¿s recommendations.Improper temperature during product transportation or storage.

Event Description

The customer reported that one bag of trima collected platelets was infused to a patient and when preparing to infuse another bag they noticed serious aggregation.The product was returned to the blood center and they verified collection, handover, storage and handout of the platelets were all normal.The blood center performed tests and found a positive bacterial culture of staphylococcus aureus.It was reported that the patient had a fever.The patient's condition is normal.The customer declined to provide further procedural details and patient information.The collection set is not available for return because it was discarded by the customer.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL PLATELET, PLASMA 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: 17549984
• MDR Text Key: 321187786
• Report Number: 1722028-2023-00278
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583803008
• UDI-Public: 05020583803008
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: BK190332
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 5803002
• Device Lot Number: 2207084151
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/21/2023
• Initial Date FDA Received: 08/15/2023
• Supplement Dates Manufacturer Received: 10/02/2023
• Supplement Dates FDA Received: 10/02/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/02/2022
• 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