MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION CAPIOX RX25 OXYGENATOR EAST; BLOOD GAS OXYGENATOR

Model Number 3CX*RX25RE

Device Problem Use of Device Problem (1670)

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

Event Date 12/30/2015

Event Type  malfunction  

Manufacturer Narrative

Terumo has not received the actual device for evaluation; 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 systems corporation that after cardiopulmonary bypass, they experienced an issue with the oxygenator.At the end of the case the blood was not level in the oxygenator while draining the circuit.No known impact or consequence to patient, as this occurred after cardiopulmonary bypass.

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 january 21, 2016.Upon further investigation of the reported event, the following information is new and/or changed: (date received by manufacturer).(indication that this is a follow-up report).(follow-up due to additional information).(b)(4).The actual device was not returned for evaluation; however a photograph of the event was provided by the user facility.Inspection of the photograph found that the blood within the oxygenator was not displaced evenly or level.Review of the device history records revealed no manufacturing issues.A retention sample from a product produced on the same day as the actual sample was obtained for functional testing.Two samples were filled with bovine blood of which hct had been set to 15% and 30% and the units were left standing still for four hours with no circulation.The samples were confirmed to be normal product as the uneven blood level could not be duplicated.The complaint has been confirmed based on the visual inspection of the provided photograph.A clinical visit to the user facility determined that the uneven fluid levels in the oxygenator at the end of the case were due to different density levels existing between the blood and the crysalloid solution that is circulated through the oxygenator at the end of the case.This causes the blood to be uneven based on how much blood is in the device and where the red blood cells settle.This is not a functional issue.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Brand Name: CAPIOX RX25 OXYGENATOR EAST
• Type of Device: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• Manufacturer Contact: shari bailey ; 125 blue ball road; elkton, MD 21921 ; 8002623304
• MDR Report Key: 5384273
• MDR Text Key: 36764961
• Report Number: 1124841-2016-00033
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130333
• 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: 02/29/2016

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2018
• Device Model Number: 3CX*RX25RE
• Device Lot Number: TL14
• Other Device ID Number: (01)00699753450103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/06/2016
• Initial Date FDA Received: 01/21/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2015
• 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