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 Rash (2033); Anaphylactoid (2218)

Event Date 11/08/2019

Event Type  Injury  

Manufacturer Narrative

Investigation: the customer stated that prior to the blood donation the donor had eaten the seafood (shrimp) in the cafeteria of the blood center and he claimed to have no other long-term medication history.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.The customer reported that the donor had anaphylaxis after donation.The symptom was a read rash all over the donor's body with pruritus.There are exanthemas all over the body, most severe in the palms and soles of the extremities with itching and tingling.Per the customer it was noted during the procedure, there was hematoma found on the donor's arm, and then the operator re-venipuncture.Per the customer there was nothing abnormal during the collection procedure.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.

Event Description

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

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

Manufacturer Narrative

This report is being filed to provide additional information in b.5, h.6 and h.10 and corrected information in a.1.Investigation: according to the feedback of consumables of batch 1906114151, terumo bct investigated the delivery and product usage.As of november 29, 2019,there were no other reported feedback received from other customers about suspected adverse reactions.Based on the feedback of suspected adverse reactions, the medical affairs department of tbct collected and searched relevant clinical data and literature, and did not find articles and reports about allergic reactions caused by the materials of consumables for platelet machine collection.Root cause: no definitive root cause for the reported allergic reaction 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.The bruising at the needle site could be associated with poor phlebotomy technique in association with difficult access or fragile vessels, and rapid return flows in some procedures can cause leakage of blood from the vessels into the surrounding tissue.

Event Description

Full patient id: (b)(6) no medical intervention was reported for the hematoma event, only a required re- venipuncture.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL LRS PLATELET, PLASMA SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 9498261
• MDR Text Key: 188233565
• Report Number: 1722028-2019-00425
• 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

• Date FDA Received: 12/19/2019
• 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
• Date Manufacturer Received: 01/23/2020
• 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: 75