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 10/21/2019

Event Type  Injury  

Manufacturer Narrative

Investigation: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.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.There are uniform exanthemas throughout the body, but no abnormalities in the puncture site for blood sampling.The customer is suspicious that the disposable set may be related to this event.The donor was reported as receiving anti allergic drugs.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: 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.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.During follow-up with the customer, it was reported that anaphylactogen was not identified but it was not believed that this was an ethylene oxide (eto) reaction.Investigation is in process.A follow-up report will be provided.

Event Description

The customer declined to provide further donor information for this event, including how the anti-allergic drugs were administered.

Manufacturer Narrative

This report is being filed to provide additional information in h.6, and h.10.Investigation: a disposable history search found 2 other reports of similar issues associated with lot 1906114151.Reported on mdr 1722028-2019-00424 and 1722028-2019-00425.Root cause: no definitive root cause for the reported adverse event could be identified from the run data file associated with this procedure.Possible causes for the donor reaction include but are not limited to the donor's 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: 9498297
• MDR Text Key: 188233774
• Report Number: 1722028-2019-00426
• 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
• 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; 03/11/2020
• Supplement Dates FDA Received: 01/10/2020; 03/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 00032 YR
• Patient Weight: 72