MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. STERILE FX25RE OX W/ RES ; BLOOD GAS OXYGENATOR

Model Number 3CX*FX25RW

Device Problem Component Missing (2306)

Patient Problem No Patient Involvement (2645)

Event Date 03/27/2015

Event Type  malfunction  

Event Description

The user facility reported to terumo cardiovascular systems corp that out of the box it was discovered that the manifold and pressure lines were missing.No pt involvement as this occurred out of the box.The procedure was not delayed.

Manufacturer Narrative

Terumo has received the actual device for eval; however, the investigation has yet to be completed.Terumo plans on submitted a follow up report when the investigation is complete and more info becomes available.For this reason, terumo referenced eval conclusion.(b)(4).

Manufacturer Narrative

This f/u report is submitted to fda in accord with applicable regulations - and as indicated by terumo cardiovascular system in the initial report submitted to the fda on april 14, 2015.Upon evaluation of the device, the complaint was confirmed.Visual inspection confirmed that the sampling manifold was missing.Magnified inspection revealed that there was a scuff mark on the slot in the reservoir lid where the sampling manifold is inserted.This indicates that a sampling manifold was most likely installed on the reservoir during manufacturing.A retention sample was visually inspected, and the sampling manifold was present.A review of the device history record revealed no production related anomalies.All available information has been placed on file in quality management for appropriate tracking, trending and follow up.

• Brand Name: STERILE FX25RE OX W/ RES
• Type of Device: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORP.; 125 blue ball rd.; elkton MD 21921
• Manufacturer (Section G): TERUMO CARDIOVASCULAR SYSTEMS CORP.; 125 blue ball rd.; elkton MD 21921
• Manufacturer Contact: robyn o'donnell, quality mgr ; 125 blue ball rd.; elkton, MD 21921 ; 8002623304
• MDR Report Key: 4698413
• MDR Text Key: 20460249
• Report Number: 1124841-2015-00094
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140774
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative,Distributor,company represent
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/27/2015

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: 11/30/2017
• Device Model Number: 3CX*FX25RW
• Device Lot Number: RP01C
• Other Device ID Number: (01)00699753450479
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/02/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Device Age: 4 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 03/27/2015
• Initial Date FDA Received: 04/14/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/08/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2014
• 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