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

Catalog Number 80300

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erythema (1840); Rash (2033)

Event Date 11/20/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The customer reported a donor had an allergic reaction on the 2nd day following a blood collection on a trima device.Per the customer, the symptom was a red rash (erythema) appeared all over the donor¿s body.The customer is suspicious that the disposable set may be related to this event.The donor was reported as receiving anti allergic drugs.Per the customer, the donor claimed to have no other long-term drug history.Donor age is not available at this time.The donor was reported as recovered after the anti-allergic treatment.The disposable set is not available for return because it was discarded by the customer.

Manufacturer Narrative

Investigation: the run data file (rdf) was analyzed for this event.No definitive root cause for the reported adverse events could be identified from the run data file associated with this procedure.There is no evidence or suspicion of device malfunction based on the run data file analysis.The system operated as intended and the procedure was run within standard operating limits.Investigation is in process.A follow-up report will be provided.

Event Description

Full patient id: (b)(6).

Manufacturer Narrative

This report is being filed to provide corrected information in a.1 and additional information in b.5.Investigation is in process.A follow up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information in a.2, h.6 and h.10.Investigation: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.All sterilization requirements passed.A disposable history search found 2 other reports of similar issues associated with lot 1906114151.See mdr 1722028- 2019-00425 and 1722028-2019-00426 for reported issues.According to aabb technical manual 16th edition, adverse events seen at the time of donation or those reported later average about 3.5% of donations.Reactions that need medical care after the donor has left the donation site are seen in 1 in 3400 donors.Root cause: no definitive root cause for the reported adverse events could be identified from the run data file associated with this procedure.Possible causes for the donor reaction include but are not limited to ac management during the procedure, the length of the procedure and/or patient sensitivity to anticoagulant or ethylene oxide used to sterilize the disposable set.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL LRS PLATELET, PLASMA SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 9498124
• MDR Text Key: 174363907
• Report Number: 1722028-2019-00424
• 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: 12/19/2019

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: 06/01/2021
• Device Catalogue Number: 80300
• Device Lot Number: 1906114151
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 11/27/2019
• Initial Date FDA Received: 12/19/2019
• Supplement Dates Manufacturer Received: 12/26/2019; 02/25/2020; 02/23/2021
• Supplement Dates FDA Received: 01/10/2020; 02/25/2020; 02/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 00047 YR
• Patient Weight: 72