MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA ACCEL AUTO RBC AND PLASMA SET

Catalog Number 80520

Device Problems Device Expiration Issue (1216); Hole In Material (1293)

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

Event Date 01/27/2016

Event Type  malfunction  

Manufacturer Narrative

Investigation is in process.A follow-up report will be provided.

Event Description

While investigating a customer claim of a hole in an anticoagulant line, it was discovered thatthe customer had used an expired set.The hole in the set's tubing had been identified at the setup of the procedure.No injury occurred with this event.The set expired (b)(6) 2015.Patient information is not available at this time.The disposable kit is not available for return, because it was discarded by the customer.

Manufacturer Narrative

This report is being filed to provide additional information and corrected information.Investigation: the customer provided photographs of the set.A review of the photographs confirmed a hole in the anticoagulant line.The expiration date of the set was also confirmed to be prior to the date of use of the set.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 root cause of the use of the expired set was determined to be an operator error.Correction: terumo bct followed up with the customer in january 2016 and explained the importance of abiding by the expiration dates with terumo bct products.

Event Description

No patient (donor) was connected at the time of the event.No patient (donor) information is reasonably known.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL AUTO RBC AND PLASMA SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: matthew bickford ; 10810 w collins ave; lakewood, CO 80215 ; 3032052494
• MDR Report Key: 5447216
• MDR Text Key: 39094754
• Report Number: 1722028-2016-00089
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• PMA/PMN Number: BK120049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2015
• Device Catalogue Number: 80520
• Device Lot Number: 05V3113
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2013
• 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