MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMALRS PLATELET PLASMA RBC AUTOPAS SET

Catalog Number	5824102
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported bacterial growth in a platelet concentrate after a donation on a trima device.Per the customer, the donor had successfully completed a total of 11 platelet donations and only this donation detected bacteria.It was reported that three days after bottling the product, during a review of the warehouse, a large mass of platelets appeared to have agglutinated in the product.Per the customer, samples were taken and analyzed by a microbiologist, and preliminary results showed that serratia marcescens bacteria was detected.The results also showed that the bacteria was sensitive to all tested antibiotics and no multiresistant strains were detected.Per the customer, the donor is "completely healthy with no symptoms of illness".Donation id: (b)(6).It was reported that the donation was discarded and there were no transfusion recipients.Due to a system limitation, the weight provided in 3.A is the donors.The platelet collection set is not available for return because it was discarded by the customer.
Additional Manufacturer Narrative
Investigation is in process and a follow-up report will be provided.
Event or Problem Description
The customer reported bacterial growth in a platelet concentrate 3 days after a donation on a trima device.Per the customer, the donor had successfully completed a total of 11 platelet donations and only this donation detected bacteria.It was reported that three days after bottling the product, during a review of the warehouse, a large mass of platelets appeared to have agglutinated in the product.Per the customer, samples were taken and analyzed by a microbiologist, and preliminary results showed that serratia marcescens bacteria was detected.The results also showed that the bacteria was sensitive to all tested antibiotics and no multiresistant strains were detected.Per the customer, the donor is "completely healthy with no symptoms of illness".Donation id: s0023 24 003283 [e] e5719 it was reported that the donation was discarded and there were no transfusion recipients.Due to a system limitation, the weight provided in a3.A is the donors.The platelet collection set is not available for return because it was discarded by the customer.
Additional Manufacturer Narrative
This report is being filed to provide additional information in b.5, h.6 and h.11 investigation: 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 no other report for similar issues on this lot.A literature review was conducted for the organism identified by the customer.Per literature review, the genus serratia comprises ubiquitous gram-negative rod-shaped bacteria belonging to the enterobacterales order.So far, 23 species are recognized within this genus, six of which have been associated with human infections, including s.Marcescens, s.Plymuthica, s.Liquefaciens, s.Rubidaea, s.Odorifera, and s.Fonticola.From these, s.Marcescens is the species most commonly isolated.In addition, s.Marcescens can infect a vast set of hosts including corals, insects, nematodes, plants, and mammals.(tavares-carreon f, de anda-mora k, rojas-barrera ic, andrade a.2023.Serratia marcescens antibiotic resistance mechanisms of an opportunistic pathogen: a literature review.Peerj 11:e14399).S.Marcescens operates as an opportunistic pathogen mainly affecting patients with prior antibiotic treatment or hosts with a weakened immune system.S.Marcescens outbreaks are frequently reported in the literature (e.G., over 100 records at the outbreak database from 1968 to 2019; however, the majority of infections are likely individual cases.At the nosocomial setting s.Marcescens infections are more frequently reported in neonatology and intensive care units (icu), where this microorganism has been isolated from catheters, oxygenation devices, prefilled syringes, needles, parenteral solutions, milk-drawers, sinks, nails, and hands of health care workers.It has been also found in disinfectant solutions or double-distilled water, reflecting its enormous metabolic versatility and capability to adapt and survive in adverse environments (tavares-carreon f, de anda-mora k, rojas-barrera ic, andrade a.2023.Serratia marcescens antibiotic resistance mechanisms of an opportunistic pathogen: a literature review.Peerj 11:e14399).Per an internal terumo bct 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 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.Root cause: 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.* inadequate post-processing laboratory practices such as qc sampling or handling techniques.

• Brand Name: TRIMA ACCEL
• Common Device Name: TRIMALRS PLATELET PLASMA RBC AUTOPAS 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: 20361331
• Report Number: 1722028-2024-00422
• Device Sequence Number: 13159969
• Product Code: GKT
• UDI-Device Identifier: 05020583824102
• UDI-Public: 05020583824102
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: BK190332
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/01/2026
• Device Catalogue Number: 5824102
• Device Lot Number: 2403164251
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2024
• Supplement Date Received by Manufacturer: 12/10/2024
• Initial Report FDA Received Date: 10/03/2024
• Supplement Report FDA Received Date: 12/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/02/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male