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

Catalog Number 82400

Device Problems Obstruction of Flow (2423); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/03/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation: per the customer the sensors were cleaned, but did not appear to have been dirty.Per the operator they suspected a donor issue, but also thought that the set could have a microleak or something else that would explain accumulation of air/bubbles in the system.A used trima set containing blood was returned for investigation.It was noted that blood had circulated throughout the set.Additionally, all product bags were removed and not returned with the set.The disposable set was visually evaluated for any mis-assembly, leak location, or defect that could have contributed to the reported incident.Air bubbles were found in the return pump header tubing and the return line.Additionally, blood clots were noted in the bottom of the return reservoir.Based on the evidence found, the clot caused alarm 122.The clot was located over the sensor, so the system believed there was still blood in the reservoir.The system calculated expected volume of blood in the reservoir and time it should take to empty that volume.When the calculated time was exceeded, the system triggered alarm 122.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that during a platelet collection on a trima device the operator saw air bubbles below the reservoir.The customer reported they received alarm '122- level sensor error - return cycle took too long to empty the reservoir'.The inlet was lowered on the device as the operator thought the blood in the return chamber "did not look right".The alarm repeated.It was confirmed with the customer that the air was in the line just below the reservoir and air did not reach the donor.The donor was disconnected without rinseback and no medical intervention was required for this event.Full patient identifier: (b)(6).

Manufacturer Narrative

This report is being filed to provide additional information in.Corrected information is provided.Investigation: per the run data file (rdf) for this event, the operator had (4) draw pressure too low alerts that may have led to an occlusion in the line which would cause the "return cycle too long to empty the reservoir alerts (4x).Foamy blood in the reservoir would correctly trigger this alarm which the customer noted.The operator noted air in the return line and ended the procedure.No rinseback was performed.Investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

This report is being filed to provide in investigation: a review of the device history record (dhr) for this unit showed no irregularitiesduring manufacturing that were relevant to this issue.Investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

Investigation: the terumo bct support specialist spoke to the cutomer on the day of call(07/08/2019) about multiple "draw pressure too low" alerts and suggested that they may haveled to occlusion in the line, which could cause the multiple "return cycle took too long to emptythe reservoir" alerts.Investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

This report is being filed to provide updated information in investigation is in process.A follow up report will be provided.

Manufacturer Narrative

Root cause: specific root cause could not be definitively determined for this incident.The alarm of low level sensor was found to be due an obstruction caused by blood clots resulting in a false detection of fluid (clot was located over the sensor, so the system believed that there was still blood in the reservoir) rather than air leading to air to donor.Specific root causes for clotting could not be determined, possible root causes include but are not limited to: inadequate anticoagulation of the extracorporeal system - the donor's physiology.

Event Description

Patient id: (b)(6).

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL LRS PLATELET, PLASMA, RBC SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 8855069
• MDR Text Key: 165017825
• Report Number: 1722028-2019-00212
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583824003
• UDI-Public: 05020583824003
• Combination Product (y/n): N
• PMA/PMN Number: BK180231
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2020
• Device Catalogue Number: 82400
• Device Lot Number: 1804205151
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2019
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 07/08/2019
• Initial Date FDA Received: 08/02/2019
• Supplement Dates Manufacturer Received: 08/02/2019; 09/19/2019; 09/23/2019; 12/12/2019; 01/08/2020
• Supplement Dates FDA Received: 08/27/2019; 09/20/2019; 10/15/2019; 12/19/2019; 01/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 00068 YR
• Patient Weight: 130