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 not received the 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 when more information becomes available.(b)(4).Results: results pending completion of evaluation.Conclusions: conclusion not yet available-evaluation in progress.

Event Description

The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during setup, the oxygenators are pulling air across the membrane when the arterial head is stopped and resumed.No patient involvement; product was changed out; procedure 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 october 27, 2017.The actual sample was not returned.A retention sample was built into a circuit with tubes and circulated with the saline solution at the flow rate of 7l/ml with the use of a roller pump.While the solution was circulating the roller pump was stopped suddenly.Air was found being pulled into the oxygenator.During the described circulating test, it was found that the pressure fell down to approximately -40 mmhg when the roller pump was stopped.Based on the investigation result, 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 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.However, a definitive root cause cannot be determined as the sample was not returned.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: 6985310
• MDR Text Key: 90976336
• Report Number: 1124841-2017-00227
• 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: health professional,user faci
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2020
• Device Model Number: 3ZZ*RX25RE
• Device Catalogue Number: N/A
• Device Lot Number: VG05
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/11/2017
• Initial Date FDA Received: 10/27/2017
• Supplement Dates Manufacturer Received: 01/04/2018
• Supplement Dates FDA Received: 01/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2017
• 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