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

Catalog Number 80420

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

Patient Problems Reaction (2414); Vaso-Vagal Response (2661)

Event Date 09/14/2018

Event Type  Injury  

Manufacturer Narrative

Investigation: the run data file (rdf) was analyzed for this event.The run data file (rdf) was analyzed for this event.Signals in the rdf indicated that the spectra optia system operated as intended.Root cause: review of the rdf showed that there were no events (alerts, adjustments, changes in pump speed, etc.) during the run that could have caused the reported anticoagulant (ac) reaction.Analysis showed this procedure remained well within the safety box limits.The ac infusion rate was between 0.5 and 0.6 ml/min/l tbv during the concurrent platelet and plasma collection, as much of the ac was being collected into the product bags.Platelet only collection occurred following the concurrent platelet and plasma collection for about 10 minutes, where the ac infusion rate increased to between about 0.8 and 0.9 ml/min/l tbv.The procedure completed at about 60 minutes with normal rinseback.The total amount of ac reported by the trima accel device was 305 ml with 198 mls to the donor, 18 mls in the platelet product, 76 mls in the plasma product and the remaining 13 mls in the kit.About 9 % of the donor¿s tbv was collected as product volume.A definitive root cause for the donor's reactions could not be determined.Possible causes for the alleged reactions include but are not limited to ac management during the procedure or the donor's sensitivity to anticoagulant.

Event Description

The customer reported a donor experienced convulsions during a trima collection procedure.The convulsion started during rinseback at the end of the procedure.The donor felt a soft paresthesia before blackout.Medical response could not determine the reason.This was a regular whole blood donor and this was their first donation by apheresis.The donor had a second blackout after they arrived at home and was sent to the hospital for diagnosis.Per the customer, the physician confirmed that the donor was ok.The patient's date of birth is not available at this time.Donor unit id: (b)(6).The trima collection exchange set was disposed of and is not available for return.

Manufacturer Narrative

This report is being filed to provide additional information.Additional investigation: according to therapeutic apheresis, the adverse events occur during therapeutic procedures with a frequency of 4.8%.Transient hypocalcemia associated with apheresis is usually well tolerated.Symptoms often show as paresthesia (tingling) but patients may also experience unusual taste, nausea, light headedness, shivering, and tremors.Severe hypocalcemia may also cause muscle contractions and can progress to tetany and seizures if hypocalcemia escalates and is not corrected.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.

Event Description

Due to eu personal data protection laws, the patient's age is not available from the customer.Patient's id, gender and weight information were obtained from the run data file (rdf).This product is not available within the us, but this report is being filed due to an alleged failure that could occur on a similarly marketed device platform cleared for use by the fda.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL LRS PLATELET,PLASMA, RBC, AUTOPAS SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: steve kern ; 10810 w. collins ave; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 7971263
• MDR Text Key: 123896947
• Report Number: 1722028-2018-00290
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: ES
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/16/2018

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: 06/01/2020
• Device Catalogue Number: 80420
• Device Lot Number: 1806061230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 09/17/2018
• Initial Date FDA Received: 10/16/2018
• Supplement Dates Manufacturer Received: 11/05/2018
• Supplement Dates FDA Received: 11/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 100