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

Catalog Number 82420

Device Problems Improper or Incorrect Procedure or Method (2017); Device Displays Incorrect Message (2591)

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

Event Date 07/13/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Sterilization process review investigation: an unused trima set was returned for investigation.Upon visual inspection, the set was confirmed to be assembled correctly.The white pinch clamps on the needle and sample bag line were inspected and confirmed to be closed appropriately.A small portion of air was present in the sample bag (it was by no means pressurized).The set was loaded onto a trima device (without adjusting the clamps); it passed the pressure test without issue.No air was routed to the sample bag.A trima disposable set was loaded on the trima device located in terumo bct's lab in an attempt to recreate the reported incident by the customer.The investigator left the white pinch clampopen on the sample bag and closed the white pinch clamp on the donor needle line.Pressure test failed and the sample bag filled slightly with air.The amount of air present in the sample bag was similar to the returned disposable from the customer.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 loading of the platelet collection set, they received a pressure alarm and noted air in the sample bag.Patient information and outcome are not available at this time.

Manufacturer Narrative

This report is being filed to provide additional information.Investigation: during customer follow up, the rn's at the customer site stated that they unloaded and discarded the trima disposable set.The patient completed the procedure on a new disposable set without issue.Investigation is in process.A follow-up report will be provided.

Event Description

This product is not available within the us, 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 and corrected information.Investigation: the run data file (rdf) was analyzed for this event.Root cause: the rdf analysis confirmed that the customer received a ¿failure to pressurize inlet¿ alert shortly after disposable test was initiated.This alert is generated when the system is unable to reach and maintain maximum positive pressure in the disposable set, which occurred during the initial check for the sample bag closure.During investigation, an unused set was loaded onto a trima device and the clamps was left open.This testing replicated the volume of air in the returned disposable set from the customer.Based on this, the root cause of the air in the sample bag was an incomplete occlusion of the sample bag line with the white clamp.This may be caused by not closing the white clamp when prompted or the clamp being skewed when closed allowing air to flow past the clamp.

Event Description

Due to eu personal data protection laws, the patient information is not available from the customer.Patient gender and weight were obtained from the run data file (rdf).

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL PLATELET,SAMPLER, PLASMA, RBC AUTO PAS SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: steve kern ; 10810 w. collins ave; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 6773403
• MDR Text Key: 82601464
• Report Number: 1722028-2017-00316
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: SE
• PMA/PMN Number: K162365
• 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: 08/08/2017

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: 03/01/2019
• Device Catalogue Number: 82420
• Device Lot Number: 1703271231
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/14/2017
• Initial Date FDA Received: 08/08/2017
• Supplement Dates Manufacturer Received: 08/25/2017; 09/14/2017
• Supplement Dates FDA Received: 08/30/2017; 09/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2017
• 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: 103