MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION NON-STER X-COATED SX25 W/RES; BLOOD GAS OXYGENATOR

Model Number 3ZZSX25RX

Device Problem Use of Device Problem (1670)

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

Event Date 08/03/2016

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.(b)(4).

Event Description

The user facility reported to terumo cardiovascular that during cardiopulmonary bypass, the blood was dark and the oxygenator appeared to not be working.The flow was raised to 10 liters per minute and 100% oxygen, that did not work.An oxygen tank was directly connected to the oxygenator with no improvement.No known impact or consequence to patient.Product was changed out.Procedure was completed successfully.

Manufacturer Narrative

This follow-up report is submitted to fda in accord with applicable regulations ¿ and as indicated by terumo cardiovascular systems in the initial report submitted to the fda on august 22, 2016.Upon further investigation of the reported event, the following information is new and/or changed: (b)(4).The sample was returned for evaluation.Review of the device history records revealed no manufacturing issues.The returned sample was visually inspected.A large crack was found in the housing of the heat exchanger and oxygenator.A retention sample from product code/lot number combination was visually inspected and found to not have any damages.Human factors issue was chosen due to these units being 100% visually inspected in process and it is likely that the damaging crack occurred during shipping or handling of the device.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Brand Name: NON-STER X-COATED SX25 W/RES
• Type of Device: BLOOD GAS OXYGENATOR
• 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: 5893064
• MDR Text Key: 52626142
• Report Number: 1124841-2016-00310
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130359
• 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: 10/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2018
• Device Model Number: 3ZZSX25RX
• Device Catalogue Number: N/A
• Device Lot Number: UC01
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/05/2016
• 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