MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. STERILE FX15REC W/ 4L RES BLOOD GAS OXYGENATOR

Model Number 3CX*FX15RE40C

Device Problem Detachment Of Device Component (1104)

Patient Problem No Patient Involvement (2645)

Event Date 11/21/2016

Event Type  malfunction  

Manufacturer Narrative

Terumo has not received the actual device; therefore, the investigation has yet to be completed. Terumo plans on submitting a follow up report when the investigation is complete and more information becomes available. (b)(4).

Event Description

The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during set up, the port where the sensor plugs in fell off when attempting to plug in the sensor on set up. There was no patient involvement as this occurred during setup. Product was changed out. Procedure was completed successfully.

Manufacturer Narrative

A second follow-up will be submitted upon completion of the investigation and/or submission of new information. All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

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. (b)(4). The sample was returned for evaluation. A review of the device history record revealed no manufacturing anomalies. The returned sample was visually inspected. It was found that the thermistor on the oxygenator was broken. The external portion of the thermistor appeared to have sheared off of the port or insert, which remained within the oxygenator port. A retention sample from the sample product / lot family was visually inspected and confirmed to have no damages. The thermistor was properly attached to the oxygenator port. All capiox units are 100% visually inspected at several points in the production process. It is likely that the thermistor was damaged by a shock force at some point during the handling of the product; however, when or how this shock force was applied was not able to be determined all available information has been placed on file in quality management for appropriate tracking, trending and follow up.

• Brand Name: STERILE FX15REC W/ 4L RES
• Type of Device: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORP.; 125 blue ball road; elkton MD 21921
• Manufacturer Contact: cathleen hargreaves ; 125 blue ball road; elkton, MD 21921 ; 8002837866
• MDR Report Key: 6154166
• MDR Text Key: 61715921
• Report Number: 1124841-2016-00417
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 01/20/2017

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 04/30/2019
• Device Model Number: 3CX*FX15RE40C
• Device Catalogue Number: N/A
• Device Lot Number: UF23
• Other Device ID Number: (01)00699753450813
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2016
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/26/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial