MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA PLT SAMPLER, AUTO PAS, MLTPLS SET

Catalog Number 82310

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/31/2024

Event Type  malfunction  

Event Description

The customer contacted terumo bct and reported platelet and plasma product contamination of bacillus mobilis.Per the customer, the product tested negative during bacterial testing, then subsequently tested positive for bacillus bacteria after a growth was noted in a platelet product, which prompted further testing and investigation.In one instance a donor¿s arm was swabbed and presented with bacillus mobilis.All products are currently quarantined (physically & electronically) but will be discarded after the investigation is comeplet, per the customer's procedures.These products were not transfused, therefore there was not a transfusion recipient or patient involved at the time of the unit processing, therefore no patient information is reasonably known at the time of the event.The platelet collection set is not available for return because it was discarded by the customer.This product is not available within the united states, but this report is being filed due to an alleged failure that could occur on a similarly marketed device platform cleared for use by the fda.

Manufacturer Narrative

Investigation: the ssp+ product applied to the platelets at collection are from macopharma.All products were processed with the biomerieux bact virtuo system using their bpa and bpn bottles (one each per pack).Given the positive return of the swabbed donor, the customer investigation is currently directed towards skin contamination introduction during collection.Investigation is in process and a follow up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h.10 (h.11).Investigation: the ssp+ product applied to the platelets at collection are from macopharma.All products were processed with the biomerieux bact virtuo system using their bpa and bpn bottles (one each per pack).Given the positive return of the swabbed donor, the customer investigation is currently directed towards skin contamination introduction during collection.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 and a follow up report will be provided.

Event Description

The customer contacted terumo bct and reported platelet and plasma product contamination of bacillus mobilis.Per the customer, the product tested negative during bacterial testing, then subsequently tested positive for bacillus bacteria after a growth was noted in a platelet product, which prompted further testing and investigation.In one instance a donor¿s arm was swabbed and presented with bacillus mobilis.All products are currently quarantined (physically & electronically) but will be discarded after the investigation is complete, per the customer's procedures.These products were not transfused, therefore there was not a transfusion recipient or patient involved at the time of the unit processing, therefore no patient information is reasonably known at the time of the event.The platelet collection set is not available for return because it was discarded by the customer.This product is not available within the united states, but this report is being filed due to an alleged failure that could occur on a similarly marketed device platform cleared for use by the fda.

Manufacturer Narrative

Investigation: the ssp+ product applied to the platelets at collection are from macopharma.All products were processed with the biomerieux bact virtuo system using their bpa and bpn bottles (one each per pack).Given the positive return of the swabbed donor, the customer investigation is currently directed towards skin contamination introduction during collection.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.A disposable lot history search was performed and it was confirmed that there were no other reported occurrences of microbial contamination on either one of these two lots worldwide.According to the aabb circular of information for the use of human blood components (revised 2017), although methods to limit and detect bacterial contamination have been implemented for most platelet components, they remain the most likely blood components to be contaminated with bacteria.Gram-positive skin flora are the most commonly recovered bacteria.Symptoms may include high fever (=2.0 c or =3.5 f increase in temperature), severe chills, hypotension, or circulatory collapse during or immediately after transfusion.In some instances, symptoms, especially when associated with contamination by gram-positive organisms, may be delayed for several hours following transfusion.Prompt management should include broad-spectrum antibiotic therapy along with cultures from the patient, suspected blood component(s), and administration set.A gram¿s stain of suspected contaminated unit(s) should be performed whenever possible.Although most platelet components are routinely tested for bacterial contamination, this does not completely eliminate the risk.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 investigation conducted by the customer, skin contaminant from the donors was likely the source of the contamination.Possible root causes include but are not limited to: 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.

Event Description

The customer contacted terumo bct and reported platelet and plasma product contamination of bacillus mobilis.Per the customer, the product tested negative during bacterial testing, then subsequently tested positive for bacillus bacteria after a growth was noted in a platelet product, which prompted further testing and investigation.In one instance a donor¿s arm was swabbed and presented with bacillus mobilis.All products are currently quarantined (physically & electronically) but will be discarded after the investigation is complete, per the customer's procedures.These products were not transfused, therefore there was not a transfusion recipient or patient involved at the time of the unit processing, therefore no patient information is reasonably known at the time of the event.The platelet collection set is not available for return because it was discarded by the customer.This product is not available within the united states, but this report is being filed due to an alleged failure that could occur on a similarly marketed device platform cleared for use by the fda.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA PLT SAMPLER, AUTO PAS, MLTPLS 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: 18784687
• MDR Text Key: 336976754
• Report Number: 1722028-2024-00063
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date: 02/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 82310
• Device Lot Number: 2302234151
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/09/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/02/2023
• 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