MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA ACCEL LRS PLATELET PLT FILTER AUTOPAS PLASMA SET

Catalog Number 82383

Device Problems Device Operates Differently Than Expected (2913); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Patient Involvement (2645)

Event Date 12/13/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation: a used leukoreduction filter was returned for investigation.Upon visual inspection, it was noted that the presence of platelets in the filter inlet and outlet tubing line and some slight platelet aggregation was noted in the outlet tubing line adjacent to the radio frequency (rf) seal.It was also noted that the platelets located in the outlet tubing line had a slight red tinge in color.The leukoreduction filter was also examined for any manufacturing defects or damage and none were found.The device history records (dhr) were reviewed for this lot.There were no events noted in the dhr that would have contributed to the elevated wbc count experienced by the customer.Investigation is in process.A follow-up report will be provided.

Event Description

The customer would like the run data file investigated to determine a possible cause for the elevated white blood cell (wbc) content in the platelet product.There was not a transfusion recipient or patient involved at the time of the residual white blood cell (rwbc) testing, therefore no patient information is reasonably known at the time of the event.Donor unit #: (b)(4).Wbc count is not available at this time.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

This report is being filed to provide additional information.Investigation: a used haemonetics leukoreduction filter was returned to terumo bct.Upon visual inspection, presence of platelets in the filter inlet and outlet tubing were observed.Slight platelet aggregation was also noted in the outlet tubing adjacent to the rf seal.Upon further examination, it was observed that the platelets appeared to have a slight red tinge in color, which may indicate a spillover and that the cells were not hemolyzed.The filter was visually examined for any manufacturing defects or damage and none were observed.The leukoreduction filter was sent to the supplier for investigation.Upon visual inspection, no observations were noted.The filter was cut open and it was observed that there were no occluded parts and the pinch was normal, even and concentric.The media pack was complete and no folds or wrinkles were observed.The filter appeared fully primed and the thickness was within manufacturing specifications.A root cause for the reported event could not be determined based on the investigation that was performed at the supplier's site.The run data file (rdf) was analyzed for this event.Root cause: the returned part investigation and run data file analysis did not show a conclusive root cause for the higher than expected wbc contamination in the platelet product reported for this collection.Based on the available information, possible causes include, but are not limited to donor related leukoreduction failure.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL LRS PLATELET PLT FILTER AUTOPAS PLASMA SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: steve kern ; 10810 w. collins ave; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 7187382
• MDR Text Key: 97953211
• Report Number: 1722028-2018-00011
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: BK170059
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/12/2018

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: 08/01/2019
• Device Catalogue Number: 82383
• Device Lot Number: 1708232130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/19/2017
• Initial Date FDA Received: 01/12/2018
• Supplement Dates Manufacturer Received: 03/14/2018
• Supplement Dates FDA Received: 03/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2017
• 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