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

Catalog Number 000000000000080420

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Bradycardia (1751); Low Blood Pressure/ Hypotension (1914); Neurological Deficit/Dysfunction (1982); Pain (1994); Vomiting (2144); Reaction (2414); Loss of consciousness (2418); Shaking/Tremors (2515)

Event Date 11/10/2014

Event Type  Injury  

Event Description

The customer reported that a donor had a citrate reaction during platelet donation procedure.41 minutes into the procedure, the donor complained of a metallic taste but no parasthesia.The rn reduced the anticoagulant (ac) ratio to 2 and the donor was given milk.Two minutes later, the donor vomited, had reduced level of consciousness, and experienced a decrease in blood pressure and pulse.He had a slow recovery with a rigor like tremulousness and developed atypical pain in his arm.He was admitted to the emergency department and tremulousness continued overnight.The donor was discharged from the hospital after 2 days.Due to eu personal data protection laws, the patient (donor) information is not available from the customer.Donor gender and weight were obtained from the run data files.The disposable kit is not available for return because it was discarded by the customer.This report is being filed due to medical intervention in the form of hospitalization.

Manufacturer Narrative

Sterilization process review investigation: per the customer, the procedure had infused 185ml of acda solution.The hospital ruled out a cardiac event, but was unsure of the cause of the donor reaction.Per the customer site physician, he expects this initial citrate reaction triggered an underlying anxiety.The run data file (rdf) was analyzed for this incident.There were no events noted in the rdf that would have contributed a donor reaction.Signals in the rdf indicate that the machine functioned as intended.Run file information from the trima system indicates that two subsequent procedures were performed successfully on the same device later that day.Checkout of the machine was performed at the customer site.The pm procedure was completed successfully and there were no issues with the machine.The manufacturing records of the acda lot were reviewed.No unusual circumstances were noted during manufacture.There have been no other reports of donor reaction associated with the disposable lot.Trima accel automated blood collection system operator's manual offers the following caution:"the trima accel system has many safety features.However, a donor reaction can occur rapidly.Therefore, it is imperative that the trima accel system and the donor be monitored throughout the procedure."root cause: rdf analysis, service call, and acda and disposable lot review shows that the device operated as intended.Statements made by the physician indicate that individual donor tolerance to citrate may be a contributing factor.

Manufacturer Narrative

This record was identified during a retrospective review of mdr's, per fda request, to identify records in which a serious injury or medical intervention occurred, but the type of reportable event was not indicated as a serious injury on the mdr form.This supplement is being filed to modify information per fda request.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL ENHANCED PLATELET,PLASMA,RBC,AUTOPAS SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: jessica kim ; 10811 w. collins ave; lakewood, CO 80215 ; 3032314812
• MDR Report Key: 4295291
• MDR Text Key: 15819821
• Report Number: 1722028-2014-00476
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• PMA/PMN Number: BK130080
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,foreign,health professi
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/11/2014

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: 07/01/2016
• Device Catalogue Number: 000000000000080420
• Device Lot Number: 07W1210
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/11/2014
• Initial Date FDA Received: 12/03/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2014
• 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
• Patient Weight: 75