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

Catalog Number 82420

Device Problems Clumping in Device or Device Ingredient (1095); Microbial Contamination of Device (2303); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 09/02/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation is in process.A follow-up report will be provided.

Event Description

The customer collected a platelet and plasma product on trima.The platelet product was inactivated using the mirasol system after the collection.Two days after collection, before the platelet product was to be transfused, the operator observed "spots and aggregates" inside the platelet product.The product was sent to the lab and tested positive for serratia marcescens and b.Cereus.The product was discarded and not transfused.The plasma product was not inactivated on mirasol.It was also sent to the lab for testing and was positive for serratia marcescens.The donor was checked and was asymptomatic.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: per the customer, they said they use laminar flow cabinet to take the sample, and they "do not load the sample" they just do "culture qualitative¿.The sample is processed same day and normally has no delay.The mirasol data was reviewed and there were no obvious errors by the operator and the mirasol device was set properly and appears to have delivered the correct dose.The trima accel operator¿s manual instructs the operator to use aseptic technique throughout all procedures to ensure donor safety and product quality.The system prompts the operator to close the blood diversion clamp on the donor access line prior to venipuncture to perform a diversion of the initial bolus of blood to the sample bag.The customer did not report finding any leaks or defects in either the plasma or platelet bags.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

There was not a transfusion recipient or patient involved at the time of this incident; therefore, no patient information is reasonably known at the time of the event.The customer reported that this apheresis donor is habitual donor.On a follow-up call with the donor, he confirmed double disinfection was performed as usual and he stated he did not have any of the following symptoms: pain, inflammation, red colour, allergic reaction, or fever.Per the customer, the procedure was done on trima 2nd of september, no issues no flag on the report, inactivation was done in mirasol 3rd of september (inside timing specifications) on mirasol.No issues or alarms in the report.Results were available september 8th.This is the day that the lab responsible gave the result t but maybe it was positive the day before, monday 7th, and sometimes is a delay between when the result is positive and when it is validate by the lab resp.The customer has reproted that they ahve had no other contaminated products since this event.

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h.10.Root cause: the specific root cause of the bacterial contamination in the mirasol-treated platelet unit and non - mirasol treated plasma unit could not be determined.However, the most plausible source of the contamination was determined to be the donor's skin either via skin plug at the time of phlebotomy, poor phlebotomy venipuncture technique, inadequate disinfection at collection, and/or asymptomatic donor bacteremia.In addition, the contamination at the time of apheresis was likely at a level that was beyond the reduction capacity of the pathogen reduction treatment.

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h.10.Investigation: 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.Investigation is in process.A follow up report will be provided.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMAACCEL LRS PLATELET SAMPLER AUTOPAS,PLASMA,RBC SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 10679875
• MDR Text Key: 213914195
• Report Number: 1722028-2020-00472
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• PMA/PMN Number: BK190332
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2022
• Device Catalogue Number: 82420
• Device Lot Number: 2007102130
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 03/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 87