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

Model Number 80410

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems Hypersensitivity/Allergic reaction (1907); Skin Discoloration (2074); No Known Impact Or Consequence To Patient (2692)

Event Date 05/21/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation: a photograph was submitted to aid in the investigation.Analysis of the image revealed a used trima access needle assembly containing blood inserted into a patient¿s arm.Tape on the patient¿s arm is seen holding the access needle in place.A rectangular red spot is seen on the patient's arm with adhesive residue in spots.It is unknown if a large sterile dressing was applied to the site at any point during the procedure.Based on the evidence found in the image provided, a definitive root cause of this failure could not be determined at this time.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported a donor having an allergic reddish arm a the needle site while donating on a trima device.It is unknown at this time if medical intervention was required for this event.Patient information and outcome are not available at this time.The platelet collection set is not available for return because it was discarded by the customer.

Manufacturer Narrative

This report is being filed to provide additional information in e1, e3, h6 and h10.The customer declined to provide reporter first name and address of the customer site.Investigation: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Root cause: based on review of the image provided, a definitive root cause for the donor's reaction could not be determined.Possible causes include but are not limited to an allergy to the disposable tubing, tape for venipuncture or sterile dressing, and/or donor sensitivity to eto.

Manufacturer Narrative

This report is being filed to provide additional information in b.6, h.6 and h.10 and corrected infromation in h.1.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.It was confirmed by the customer that no medical intervention was required for the allergic reaction.Investigation is in process.A follow up report will be provided.

Event Description

It was confirmed by the customer during follow-up that no medical intervention was required for the allergic reaction and the customer finished the collection process.

Manufacturer Narrative

This report is being filed to provide additional information in b.5 and h.10.Investigation: based on literature reference, therapeutic apheresis: a physician's handbook, allergic reactions are usually associated with replacement procedures that include blood components, but sensitivity to disposable tubing sterilized with ethylene oxide can also be associated with allergic reactions.Investigation is in process.A follow up report will be provided.

Event Description

The customer declined to provide patient information.The patient is reported as stable.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL LRS PLATELET + AUTO PAS, PLASMA, RBC SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 10153510
• MDR Text Key: 200870707
• Report Number: 1722028-2020-00292
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583804104
• UDI-Public: 05020583804104
• 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: 06/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2021
• Device Model Number: 80410
• Device Catalogue Number: 80410
• Device Lot Number: 1908152130
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 05/21/2020
• Initial Date FDA Received: 06/15/2020
• Supplement Dates Manufacturer Received: 06/22/2020; 09/18/2020; 10/19/2020
• Supplement Dates FDA Received: 07/07/2020; 10/05/2020; 10/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other