MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA PLATELET SAMPLER PLASMA RBC SET

Model Number 82440

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Reaction (2414); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/22/2020

Event Type  malfunction  

Manufacturer Narrative

Investigations: lot number and expiry information are not available at this time investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that in two days they had three donor citrate reactions on trima v7.This report is for the second of the three reactions.Donor started tingling from head to toe from first return and remained that way over the duration of the collection.Approximately 50 min into collection, donor took tums to offset the metallic taste and mild nausea.Donor received approximately 400 ml of acd-a over this procedure which was a slightly higher volume from 4 weeks earlier when she donated a double in 80-84 min with no tingling (paresthesia) at all.The procedure was completed without further issue.Rinseback was completed and donor recovered for about 10 min before getting up.This donor was a staff member and seasoned platelet donor.She completed the procedure knowing products were needed and these feelings would pass.Fellow staff told this donor she looked washed out.She stated she felt like she was in a fog over the next couple of hours and she c/o being emotionally labile later in the day.She stated she went home, ate dinner and went to bed.When she awoke the next a.M., she was ok but there was residual very mild paresthesia to mouth and chin for a full 24 hour from end procedure until complete resolution.Donor received approximately 400 ml of acd-a over this procedure which was a slightly higher volume from 4 weeks earlier when she donated a double in 80-84 min on 1t02573 with no paresthesia at all.Tbv processed was 4771ml.This donor donated > 4 wks ago on v7 correct connect.For the previous procedure, hematocrit was 45% and platelets 350, then this donation hct was 39 and plt 303.Donor (patient) id, age, and weight are not available at this time.The disposable 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 b.5, d.4, h.4, h.6 and h.10.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 further medical intervention was required beyond the oral otc tums that was provided.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.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.The disposable lot query was performed for lot: 2003104151 and no similar reported occurrences were received against this lot to date.Investigation is in process.A follow up report will be provided.

Event Description

The customer declined to provide patient identifier, age, and weight.The customer stated from the first return and throughout procedure the donor said they felt wide paresthesia and general malaise.The donor complained of feeling washed out for 4-5 hours.This procedure was a 94 min double platelet collection, the donor received 402ml acd-a, tbc processed 4771 ml.This donor donated over 4 weeks ago on v7 correct connect the donor's hct 45 and plt 350 then this donation hct was 39 and plt 303 - no citrate issues noted.Per the customer, this donor received calcium replacement (tums), 6-8 over the duration of the procedure.Pretzels and sodas were consumed during the procedure.

Manufacturer Narrative

This report is being filed to provide additional information.Root cause: a definitive root cause for the patient's reaction could not be determined.Possible causes for the alleged citrate 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 PLATELET SAMPLER PLASMA RBC SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 10285895
• MDR Text Key: 200617467
• Report Number: 1722028-2020-00338
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583824409
• UDI-Public: 05020583824409
• Combination Product (y/n): N
• PMA/PMN Number: BK190332
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2022
• Device Model Number: 82440
• Device Catalogue Number: 82440
• Device Lot Number: 2003104151
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 03/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ACDA LOT# 20044002
• Patient Outcome(s): Other