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

Catalog Number 80360

Device Problem Clumping in Device or Device Ingredient (1095)

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

Event Date 08/17/2015

Event Type  malfunction  

Manufacturer Narrative

Investigation: per the customer, the ac bag was weighed and it was found that only about 10ml of ac had been used for the 69 minute procedure.During the procedure, the customer received a low platelet concentration alarm and they pressed the clumping down button.38 minutes later they received a level sensor error and they were unable to complete rinse back.The customer returned a used disposable set containing blood for investigation.The set was visually inspected for kinks, occlusions, missing parts, misassembly and leaks which may have contributed to the reported complaint, none were found.It was noted that there were observable clots and clumping throughout the set.A full bag of ac with spike attached was also provided with the return.The machine was checked out at the customer site by a terumo bct service technician.A full autotest and simulated use saline run were performed with no issues found.Technician found that the machine was pulling ac and was within manufacturer specifications.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that after a collection procedure they noticed clumps in the platelet bag, plasma bag and red blood cell bag.They checked the anticoagulant (ac) bag and it looked like no ac had been used during the procedure.Rinseback to the patient could not be performed due to a return pressure high alarm.The donor appeared to have no side effects from the incident and waited for 15 minutes afterwards before he left the customer center.No medical intervention was required for this event.Patient age is unavailable at this time.

Manufacturer Narrative

Investigation: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.The run data file (rdf) was analyzed for this event.Review of the procedure indicated that the customer experienced five draw pressure low alerts and two return pressure too high alerts prior to ending the procedure.Root cause: the root cause for this issue is unknown at this time.Possible causes include but are not limited to:- donor access problem- kinked or clamped draw line- ac ratio issues.

Manufacturer Narrative

This record was identified during a retrospective review of mdrs to identify records in which an event occurred, but the type of reportable event was not indicated appropriately.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL ENHANCED PLATELET, PLS, RBC, AUTO RBC 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: 5070922
• MDR Text Key: 25615081
• Report Number: 1722028-2015-00525
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK140180
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Followup,Followup
• Report Date: 08/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2017
• Device Catalogue Number: 80360
• Device Lot Number: 07Y3220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2015
• 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
• Patient Weight: 85