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 Blood Loss (2597)

Event Date 07/12/2017

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 during cardiopulmonary bypass, the unit failed, it was not oxygenating.The blood did not turn into red after 8 minutes on bypass.The patient was stable pre-cpb and the color of the venous blood coming from the patient at the initiation of bypass was normal, not very dark.They went on bypass and the arterial blood didn't not turn bright red as usually seen after initiation of cpb.Initially they had the fio2 at 80% and increased it to 100%.They checked all the oxygen line connections then bypassed the vaporizer and checked to see if gas was flowing out of the oxygen line to the oxygenator and there was gas flow.They connected an e-cylinder of oxygen directly to the oxygenator and the blood still did not turn red.They then made the decision to transfuse the blood from the reservoir to the patient, had anesthesia ventilate and came off bypass.The patient was hemodynamically stable and able to support himself while the clinician(s) cut a new oxygenator into a bypass line they have in their cpb circuit around the oxygenator.The account decided to put a bypass loop around the oxygenator in the event that they had to change out an oxygenator in the future.They inserted the replacement oxygenator into the bypass loop and that is why there was only about 50 ml of blood loss.There was no sequela to the patient as a result of the oxygenator event, the patient was discharged home 3-4 days postop.Blood loss of < 50 cc; product was changed out; with 6 to 7 minutes delay in the procedure; 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 07, 2017.(b)(4).The actual sample was not available for evaluation; therefore, the cause of the complaint cannot be determined.Possible cause of the deterioration in the gas transfer performance immediately after the initiation of the circulation includes the circulation flow rate was not sufficient for the patient's body surface area.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: 6772205
• MDR Text Key: 82060769
• Report Number: 1124841-2017-00168
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K1513213
• 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: 09/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Model Number: 3ZZ*RX25RE
• Device Catalogue Number: N/A
• Device Lot Number: VC27 OR VD13
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2017
• 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