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

Catalog Number 000000000000080410

Device Problems Failure to Sense (1559); Device Displays Incorrect Message (2591)

Patient Problem No Information (3190)

Event Date 06/17/2015

Event Type  malfunction  

Event Description

The customer reported that they loaded a trima disposable set, then during air removal, they received an 'air in the tubing' alarm.The trima display screen prompted the customer to check the clamps on the donor line and sample bag line and to 'remove the air accumulated in the bags'.The customer unloaded and reloaded the disposable set and got the same alarm.The customer unloaded the set, restarted the trima machine and reloaded the set.The air was then successfully removed.During prime of the disposable set, the anti-coagulant (ac) bag was connected and the solution was not detected by the ac sensor.After several attempts to continue the procedure, the trima machine alarmed and forced the customer to end the procedure.Donor outcome is unavailable at this time.Due to eu personal data protection laws, the patient information is not available from the customer.

Manufacturer Narrative

(b)(4).Investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

Additional manufacturer evaluation method code: sterilization process review investigation: the disposable set was returned for evaluation.Upon visual inspection, the set was confirmed to have been assembled correctly.No notable air was present in the sample bag.Both white clamps adjacent to the needle were closed and confirmed to appropriately block flow.The set contained a small amount of ac.Flow testing confirmed no other blockages in the disposable.In summary, no disposable defects were identified.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Root cause: the part evaluation did not show any malfunction or defect of the disposable device.The customer's description of alerts indicates that the sample bag may have filled with air.The cause for the sample bag filling with air is inconclusive but the sample bag can fill with air in the set is not clamped according to screen prompts or if the clamp does not fully occlude the tubing lines prior to air removal step.Additional alerts will occur if the air is not expressed from the sample bag as prompted by the system prior to reloading the set.The customer description also indicates that the ac sensor did not see the ac solution after connecting the ac bag.Possible causes for this include ac tubing line not loaded properly into the ac air detector sensor, an occluded or kinked ac line, or a defective ac air detector.The customer stated that the system alarmed to finish and unload the set.Correction: a voluntary medical device product recall notice was distributed to customers detailing the possible failure modes, necessary actions to be performed by the customer if air is in the bag, and risks to the donor.Corrective action: an internal capa has been initiated to evaluate reports of air in sample bag.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL LRS PLATELET, PLASMA, RBC + AUTO PAS SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: glenda o'neill ; 10810 w. collins ave; lakewood, CO 80215 ; 3032314051
• MDR Report Key: 4922952
• MDR Text Key: 18874506
• Report Number: 1722028-2015-00258
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: BK140180
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,foreign,health professi
• Reporter Occupation: Health Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 06/25/2015

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: 10/01/2016
• Device Catalogue Number: 000000000000080410
• Device Lot Number: 10W1115
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/25/2015
• Initial Date FDA Received: 07/17/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other