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

Catalog Number 80440

Device Problems Air Leak (1008); Hole In Material (1293); Device Displays Incorrect Message (2591); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Patient Involvement (2645)

Event Date 03/16/2018

Event Type  malfunction  

Manufacturer Narrative

An unused set was returned for investigation.Upon visual inspection, it was noted that the donor needle was detached and not provided and the white pinch clamps on the inlet coil were in the closed position.The blue pinch clamp was in the open position.It was found that the sample bag did not contain air upon return of the disposable set.The sample bag,tubing line and the 3:1 manifold were submerged in a water bath and pressurized with up to 20 psi of air.All tubing bonds were manually manipulated and no signs of a leak were noted.The disposable was also visually examined for any misassembly, leak location, or defect that could have contributed to the reported incident with no anomalies observed.All pressure sensors were inspected and determined to be functioning properly.All witness and wear marks indicated individual loop and channel components were properly loaded.The return disposable set was loaded onto the trima machine in the lab and all on screen prompts for clamping were followed.The set passed loading, tubing set test and made it to the connect ac stage.The procedure was halted at this point and the set was unloaded.No alarms or errors were encountered.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Corrective action: an internal capa has been initiated to evaluate reports of air in sample bag.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that they received a pressure test alarm prior to the start of a collection procedure.While the rn unloaded and reloaded the disposable set, she noticed a large amount of air in the sample bag.As the rn squeezed the air out from the sample bag,she noted air escaping from a pin hole leak at the ¿y joint¿ connection of the sample bag.Perthe customer, all the white clamps were closed during the first and second load of the disposable set.No patient (donor) was connected at the time of the event.No patient (donor) information is reasonably known.

Manufacturer Narrative

This report is being filed to provide additional information.Investigation: the run data file (rdf) was analyzed for this event.The rdf indicate that the cassette did not pass the high pressure decay test during the disposable test and was not holding pressure.Signals indicated that the trima machine alarmed as intended based on the aps signal.Root cause: the returned set was evaluated and no defects or misassemblies were found.Based on customer's statements, the sample bag was full of air prior to phlebotomy.This combined with the run data file analysis indicate that either the sample bag and/or needle line clamps was not closed at the system prompt or the clamp was closed but it was skewed on the tubing allowing a portion of the tubing to allow air to pass.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL ENHANCED PLATELET, PLASMA, RBC SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: steve kern ; 10810 w. collins ave; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 7429855
• MDR Text Key: 106013681
• Report Number: 1722028-2018-00098
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK170059
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2019
• Device Catalogue Number: 80440
• Device Lot Number: 1712235151
• Other Device ID Number: 05020583804401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 04/18/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/26/2017
• 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