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

Model Number 3CX*RX25RW

Device Problem Use of Device Problem (1670)

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

Event Date 11/17/2015

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/or when more information becomes available.For this reason, terumo referenced evaluation conclusion code (b)(4).(b)(4).

Event Description

The user facility reported to terumo cardiovascular systems that during cardiopulmonary bypass, at the end of the case and while off pump, the fluid level in the oxygenator was uneven and not sitting level.This event occurred while the user was draining the circuit.No known impact or consequence to patient.Product was not changed out.Surgery was completed successfully without delay.

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 december 3, 2015.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.The retention sample was filled with bovine blood and then drained by gravity.The blood level remained horizontal to the ground and never became uneven.In order to replicate the uneven blood level in the oxygenator seen in the provided picture, the oxygenator module must be physically tilted.Although a definitive root cause could not be determined, the complaint has been confirmed based on the visual inspection of the provided photograph.All available information has been placed on file in quality management for appropriate tracking, trending and follow up.

• Brand Name: CAPIOX RX25 OXYGENATOR WEST
• Type of Device: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS; 125 blue ball road; elkton MD 21921
• Manufacturer Contact: robyn o'donnell ; 125 blue ball road; elkton, MD 21921 ; 8002623304
• MDR Report Key: 5263553
• MDR Text Key: 32592145
• Report Number: 1124841-2015-00317
• 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
• Type of Report: Initial,Followup
• Report Date: 01/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2018
• Device Model Number: 3CX*RX25RW
• Device Lot Number: TK24
• Other Device ID Number: (01)00699753450110
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Device Age: 3 MO
• Date Manufacturer Received: 01/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2015
• 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