MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA ACCEL LRS PLT,PLT FILTER,AUTO PAS, PLASMA SET

Catalog Number 82383

Device Problems Air Leak (1008); Device Operational Issue (2914)

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

Event Date 04/20/2017

Event Type  malfunction  

Manufacturer Narrative

Sterilization process review investigation: the disposables set was returned to terumo bct for evaluation.Upon visual inspection, it was confirmed to have been assembled correctly.Some very small air bubbles were visible in the 3 lines of the inlet coil (ac/inlet/return) but they may be simply due to blood moving during transportation.No significant clotting/clumping was apparent in the channel or in the cassette.The run data file (rdf) was analyzed for this event.Analysis of the run data file did show that at the beginning of blood prime the access pressure dropped below the alert limit and 14 ¿draw pressure too low¿-alerts with pausing of the pumps were generated.Draw pressure alerts this early in the procedure are generally indicative of the venous access requiring adjustment.Analysis did not conclusively identify the cause of air being in the return line as reported by the customer.It is possible, though not conclusive, that the multiple draw alerts early in the procedure contributed to this observation.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that during the first draw cycle of a donation procedure, the operator noticed air in the return line.The operator stopped and aborted the procedure without rinse back.Patient identifier and age are not available at this time.Patient's gender and weight were obtained from the run data file (rdf).Patient outcome is not available at this time.This product is not available within the u.S, 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 in investigation is still in process.A follow-up report will be provided.

Event Description

Due to eu personal data protection laws, the patient's identifer, age, and outcome are not available from the customer.

Manufacturer Narrative

This report is being filed to provide additional information.Investigation: the disposables set was returned to terumo bct for evaluation.Upon visual inspection, it was noted that there were no visible signs of a leak path in the return line, pump header, or manifold that could have contributed to the air in the disposable.Root cause: a definitive root cause could not be determined.Based on the investigation, possible cause includes but is not limited to: multiple draw alerts early in the procedure contributed to this observation.Analysis of the run data file did show that at the beginning of blood prime the access pressure dropped below the alert limit and 14 ¿draw pressure too low¿ alerts with pausing of the pumps were generated.Draw pressure alerts this early in the procedure are generally indicative of the venous access requiring adjustment.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL LRS PLT,PLT FILTER,AUTO PAS, PLASMA SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: steve kern ; 10810 w. collins ave; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 6609335
• MDR Text Key: 76724166
• Report Number: 1722028-2017-00214
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: BK160116
• 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: 06/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2019
• Device Catalogue Number: 82383
• Device Lot Number: 1701242231
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2017
• 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
• Patient Weight: 55