MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION STERILE AF WITH X-COATING; ARTERIAL LINE BLOOD FILTER

Model Number 3CXAF200X

Device Problem Device Expiration Issue (1216)

Patient Problem No Patient Involvement (2645)

Event Date 07/07/2016

Event Type  malfunction  

Manufacturer Narrative

Terumo has received the device for evaluation; however, the investigation has yet to be completed.Terumo plans on submitting a follow-up report when the investigation is complete and when more information becomes available.For this reason, (b)(4).

Event Description

The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, while the product was being unpacked, it was noticed that the expiration date was a shorter date than normal.No patient involvement as this occurred out of box.

Manufacturer Narrative

This follow-up report is submitted to the fda in accord with applicable regulations - and as indicated by terumo cardiovascular system in the initial report submitted to the fda on august 1, 2016.(b)(4).The samples were returned for evaluation.A review of the device history record revealed no manufacturing anomalies.The returned samples were visually inspected and the expiration date of the product was confirmed to be 2016-08.There were no anomalies with the product itself.The product was confirmed to have a close expiration date to the time of receipt.When the product was manufactured, the proper expiration date was given; however, the demand for the single sterile product was not high and it was not ordered for quite some time.This allowed the product to age and come closer to its expiration date when it was ordered by the customer.There is no issue with the product functionality, this is a customer preference issue as they wanted more recently manufactured filters as to keep them from expiring before use.All available information has been placed on file in quality management for appropriate tracking, trending and follow up.

• Brand Name: STERILE AF WITH X-COATING
• Type of Device: ARTERIAL LINE BLOOD FILTER
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball rd; elkton MD 21921
• Manufacturer Contact: shari bailey ; 125 blue ball rd; elkton, MD 21921 ; 8002837866
• MDR Report Key: 5836346
• MDR Text Key: 50829356
• Report Number: 1124841-2016-00294
• Device Sequence Number: 1
• Product Code: DTM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K002026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/22/2016

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: 08/31/2016
• Device Model Number: 3CXAF200X
• Device Catalogue Number: N/A
• Device Lot Number: QL03
• Other Device ID Number: (01)00699753450387
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/07/2016
• Initial Date FDA Received: 08/01/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/03/2013
• 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