MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION NS RX25RE OX W RES; BLOOD GAS OXYGENATOR

Model Number 3ZZ*RX25RE

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 09/16/2017

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.For this reason, terumo references (b)(4).

Event Description

The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during prime, the oxygenators were pulling air across the membrane when the arterial head was stopped and resumed.  *no patient involvement, *product was changed out, *procedure was completed successfully.

Manufacturer Narrative

This follow-up report is submitted to fda in accord with applicable regulations.The returned sample was visually inspected.No obvious anomaly was found, such as a break, which would relate to the reported issue in the appearance.Saline solution was filled in the blood phase.With the blood outlet port side clamped, an air pressure of 2kgf/cm2 was applied to the blood phase from the blood inlet port side.No leak was confirmed.The sample was built into a circuit and primed, no air remained inside the oxygenator.The sample was circulated at the flow rate of 7l/min with a roller pump.The roller pump was stopped suddenly and air was found to be being pulled into the oxygenator.It was found that the pressure fell down to approximately -40mmhg at the stop of the roller pump.The investigation result verified that the actual sample was the normal product with no anomaly related to air entrainment.It is assumable, as a cause of this complaint, that abrupt decrease in the flow rate generated by stopping the roller pump led the pressure inside the actual oxygenator to be negative, resulting in air entrainment into the oxygenator.As a cause of the pressure inside the oxygenator having been negative, it is likely that the flow of the prime into the oxygenator was cut off when the roller pump was stopped while the prime inside the oxygenator was still flowing out of the oxygenator by inertial force.From the available information, however, it is difficult to determine the cause of this complaint definitely.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Brand Name: NS RX25RE OX W RES
• Type of Device: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• Manufacturer Contact: cathleen hargreaves ; 125 blue ball road; elkton, MD 21921 ; 8002837866
• MDR Report Key: 6981345
• MDR Text Key: 90988588
• Report Number: 1124841-2017-00220
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153213
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Model Number: 3ZZ*RX25RE
• Device Catalogue Number: N/A
• Device Lot Number: VF08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/09/2017
• 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