MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA ACCEL PLATELET, PLASMA, SET, JAPAN

Catalog Number 80337

Device Problems Device Alarm System (1012); Kinked (1339)

Patient Problem Hemolysis (1886)

Event Date 12/18/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).All signals in the rdf appear as expected, with no failure detected.The disposable set was returned for investigation.Upon visual inspection, the customer's report of a kink in the plasma recirulation line tubing was confirmed.Root cause: the root cause for hemolysis was found to be the kink in the tubing.The common causes of tubing kinks, indentations and compressions are typically related to slight variations during tray packing.Tubing is not affixed within the packaging and shifting may occur during packaging and transport to sterilization.Following exposure to the heat and humidity of the sterilization cycle, the tubing may assume a deformed shape.Only the most severely occluded kinks in the tubing should be cause for rejection to prevent usage of these disposables in procedures.

Event Description

The customer reported that after a donation, the operator found a kink on the plasma recirculation tubing line.The operator stated that they did not receive any alarms during the procedure and noticed the blood in the tubing line was red in color and was concerned about hemolysis.A blood sample from the needle and from the 3-lumen tubing was tested by the customer and they reported that they found a small amount of hemolysis.The platelet product from this collection was discarded.Per the customer the donor followed up with a physician and confirmed no issues with his potassium and was in good health.Patient (donor) information is unavailable from the customer due to japan's privacy protection laws.The patient's (donor) gender and weight were obtained from the run data file.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.

Manufacturer Narrative

This report is being filed to provide additional information.Correction: manufacturing staff were made aware of this incident and the manufacturing operating procedure (mop) were modified to orient the recirculation line in a manner so that it lies flat and kinks are minimized.

Manufacturer Narrative

Root cause updated: the presence of hemolysis at a low level is normal after the rinseback process.A small amount of free hemoglobin is generated in the last phase of rinseback on trima accel.However, the amount generated can be easily bound and removed from the donor naturally.Therefore no health risk is associated with the amount of free hemoglobin returned to the donor in a trima accel procedure.Run data file analysis is unable to confirm the contents in the plasma line during rinseback due to the plasma line joining the platelet line after the rbc detector.However, the run data file shows that plasma only passed through the recirculation line during blood prime and rinseback.Plasma was collected up to 26 minutes into the procedure, therefore not passing through the recirculation line.During platelet only collection, the plasma pump was stopped.All signals in the run data file appear as expected.

Manufacturer Narrative

Root cause continued: during the entire procedure, no rbc's are passed through the plasmarecirc line.Therefore, the kink could not cause hemolysis.Based on the available evidence, a root cause for the reported hemolysis could not be identified.A possible cause includes but is notlimited to:-donor physiology.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL PLATELET, PLASMA, SET, JAPAN
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: matthew bickford ; 10810 w collins ave; lakewood, CO 80215 ; 3032052494
• MDR Report Key: 5360930
• MDR Text Key: 36281896
• Report Number: 1722028-2016-00012
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2017
• Device Catalogue Number: 80337
• Device Lot Number: 10Y0503
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/24/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2015
• 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): Other
• Patient Weight: 60