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

Catalog Number 000000000000080400

Device Problem Shelf Life Exceeded (1567)

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

Event Date 06/07/2015

Event Type  malfunction  

Event Description

The customer reported that they received two boxes of expired trima disposable sets with an expiry date of 05/01/2014.The expired disposable sets were not used, therefore no patient information is available.The disposable sets are not available for return because they were discarded by the customer.

Manufacturer Narrative

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

Manufacturer Narrative

Investigation: a review of the device history record (dhr) for this unit showed no issues with the labeling or manufacture of the lot that would have contributed to the expired cases being shipped.Lot 05u3117 has expiration date of may 1st 2015 but was shipped directly from terumo bct to the customer in (b)(6) in 2015.Terumo bct was notified of the shipped expired lot on july 6th 2015.There are no other known occurrences on trima product line.The issue is bracketed to the two cases of lot 05u3117 because all sets of lot 05u3117 were shipped to customers in 2012 prior to the expiration date except for the two cases recently sent to customer in (b)(6).It was confirmed in the internal inventory system that the last goods delivery of this lot was issued on june 7th 2012.After that date, the system made no movements to move the lot to short shelf life to be destroyed.Then a delivery of the two cases of the lot was issued on june 5th 2015 by the system.Root cause: it is confirmed through internal inventory system review that this lot had the correct expiry date of 5/1/2014 and the expiry was never changed in the system.Movement to short shelf life is an inventory system function.The root cause for the shipment of expired product is due to a malfunction of the inventory system controls.Correction : a correction was implemented for this incident.(b)(4) was initiated to bring back the expired cases.The two cases were returned to terumo bct and scrapped (the sets were not discarded by the customer as reported in the initial report for this event).Corrective and preventive action: an internal capa was generated for this incident.

Manufacturer Narrative

This record was identified during a retrospective review of mdr's to identify records in which an event occurred, but the type of reportable event was not indicated appropriately in the mdr form.This supplement is being filed to modify information in and to align with the reported event.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL PLATELET, PLASMA, 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: 4956322
• MDR Text Key: 6037407
• Report Number: 1722028-2015-00469
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: SV
• PMA/PMN Number: BK110068
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Invalid Data,foreign,health professional
• Reporter Occupation: Health Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 07/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2014
• Device Catalogue Number: 000000000000080400
• Device Lot Number: 05U3117
• Was Device Available for Evaluation?: No
• 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: 05/19/2012
• 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