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

Catalog Number 80400

Device Problems Air Leak (1008); Improper Flow or Infusion (2954)

Patient Problem No Code Available (3191)

Event Date 11/11/2015

Event Type  Injury  

Manufacturer Narrative

Investigation: the customer returned the disposable set for investigation.Visual inspection confirmed the set was assembled correctly with no kinks, occlusions or missing parts.Fluid was confirmed in the inlet, return and channel lines and was present throughout the cassette.In summary, there did not appear to be a problem with the disposable.The run data file (rdf) was analyzed for this event.The trima accel system operated as intended by generating the ¿return cycle took too long to empty the reservoir¿ non-recoverable alarm, as the lower level reservoir sensor does not see air following a set volume pumped by the return pump at the first return cycle.Run data file analysis did not show a conclusive root cause for this alarm.It "ipossible", though not conclusive, that the two return pressure too high alerts at the start of the return cycle may have contributed to the longer than expected first return cycle.Other possible causes for the long return cycle include, but are not limited to:- partial obstruction on there turn line tubing- partial occlusion in the return line tubing- partial occlusion at the venipuncture site- incorrectly loaded tubing set- return pump header loaded incorrectly- defective reservoir level sensors or ones that require cleaning this alarm is a shutdown alarm to ensure no air is returned to the donor.Investigation is in process.A follow-up report will be provided.

Event Description

The customer noticed reduced flow from the donor's vein, after initiating a collection procedure.After the first return they received a 'return cycle took too long to empty the reservoir'.Air went into the set tubing to the sampling needle,although the container in the cartridge was about half filled with the donor's blood.The procedure was interrupted and the product was not removed from the set.The patient's (donor) gender and weight were obtained from the run data file.The patient's (donor) identifier, age and outcome are not known at this time.

Manufacturer Narrative

This report is being filed to provide additional information.Investigation is in process.A follow-up report will be provided.

Event Description

Due to eu personal data protection laws, the patient identifier, age, and patient outcome is not available from the customer.

Manufacturer Narrative

Investigation: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.The customer was unable to provide further clarification of the location or estimated volume of air that was seen in the tubing to the sampling needle.The customer does not allege that air was delivered to the donor; only that air was seen into the tubing to the needle.Based on the customer¿s description of events and the review of the procedural file, air could only have been located in the section of tubing between the needle and the 3-to-1 manifold.This section¿s volume was calculated to be 2.053ml and when considering the donor¿s weight of (b)(4), the potential bolus is 0.02ml/ kg, for which the risk of injury is none, per internal documentation.Root cause: a definitive cause for the reported air in the needle line could not be determined.It is possible, but not limited to, that there was a poor venipuncture which was then adjusted and allowed air into the needle line.The trima accel system operated as intended by generating the ¿return cycle took too long to empty the reservoir¿ non-recoverable alarm.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL PLATELET, PLASMA, RBC SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: matthew bickford ; 10810 w collins ave; lakewood, CO 80215 ; 3032052494
• MDR Report Key: 5312077
• MDR Text Key: 33943134
• Report Number: 1722028-2015-00659
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• PMA/PMN Number: BK140180
• 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
• Report Date: 12/18/2015

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: 06/01/2017
• Device Catalogue Number: 80400
• Device Lot Number: 06Y3104
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/23/2015
• Initial Date FDA Received: 12/18/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/05/2016; 04/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/05/2015
• 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: 92