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

Catalog Number 80405

Device Problems Microbial Contamination of Device (2303); No Apparent Adverse Event (3189)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/27/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation: the customer performed sterility tests on the anticoagulant solution and also on the kit and there was no microbiological growth in any of the materials.Per the customer, the disposable set was assembled the day before the collection procedure to save time the next day.Therefore, these disposables were exposed for about 10-12 hours prior to use.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported 6 instances of microbial contamination in the products collected on trima device.Per the customer, after a few days of incubation, the microbiological test is positive.In some units the test was repeated and has not been confirmed.In other cases, it was not possible to repeat the test because the product had already been transfused.It is not yet clear which products were re-tested and which products were transfused.There are no reports of consequences to the patients who received the products that showed positivity in the first test.These patients were followed up and did not develop symptoms related to suspected microbiological contamination.This report is being filed for the sixth of the six microbial contaminations.Patient information is not available at this time.The disposable set is not available for return because it was discarded by the customer this product is not available within the us, 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: a disposable history search for lot 1910291130 found one other report of similar failure worldwide, also located at this customer site.The device history record (dhr) was reviewed for this lot.There were no issues noted in the dhr that would have contributed to this event.All quality labs and sterilization requirements passed.Investigation is in process.A follow up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information in b.5, e.3, h.6 and h.10 and corrected information in e.1.Investigation: during follow-up with the customer it was reported that there were no more cases of contamination involving the apheresis platelets.They decided to change the sop in which the set is only mounted on the machine on the day of the procedure and there will be no more situations where the set is left mounted on the machine overnight.They decided that if there is any new case of contamination they will send the same sample to two different laboratories to assess if there is any problem in the microbiological identification.Per internal sterility documentation, the devices terumo bct manufactures to collect, separate, and store blood products are terminally sterilized to a sterility assurance level (sal) of

Event Description

Patient and donor information are not available per the customer.

Manufacturer Narrative

This report is being filed to provide investigation: further evaluation of this event has determined that the device did not cause or contribute to a death or serious injury, nor is there a likely potential for death or serious injury associated with this event based on additional investigational information.The customer confirmed that there was not a contamination of this product.Investigation is in process.A follow up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h.10.Investigation: per literature review, bacillus organisms are widely distributed in the environment although the primary habitat is the soil.These organisms are usually found in decaying organic matter, dust, vegetable, water, and some species are part of the normal flora.In the clinical setting, outbreaks and pseudo epidemic have been traced to contaminated ventilator equipment, disinfectant (ethyl alcohol), hospital linen and dialysis equipment.Root cause: a definitive root cause could not be determined.Sources of bacterial contamination include but are not limited to improper venipuncture technique, no blood diversion performed, a compromised needle, and/or pre or post-processing laboratory practices such as qc sampling or handling techniques.It is possible that the set was loaded over 24 hours prior to use resulting in contamination of set resulting in bacterial contamination of product.The customer did not report leaks in the disposable sets that may have pointed toward an instance where bacteria could be introduced.Consequently, the system was found to have operated as intended.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL LRS PLATELET, PLASMA, RBC SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 10454397
• MDR Text Key: 209580616
• Report Number: 1722028-2020-00411
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/26/2020

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 Expiration Date: 10/01/2021
• Device Catalogue Number: 80405
• Device Lot Number: 1910291130
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 08/04/2020
• Initial Date FDA Received: 08/26/2020
• Supplement Dates Manufacturer Received: 09/08/2020; 10/27/2020; 12/01/2020; 01/25/2021
• Supplement Dates FDA Received: 09/17/2020; 11/02/2020; 12/15/2020; 01/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other