MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION NS FX25REC W/RES; BLOOD GAS OXYGENATOR

Model Number 3ZZ*FX25RECA

Device Problem Use of Device Problem (1670)

Patient Problem Blood Loss (2597)

Event Date 09/13/2017

Event Type  Injury  

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).

Event Description

The user facility reported to terumo cardiovascular that during cardiopulmonary bypass for aortic dissection, the oxygenator failed.The partial pressure of oxygen (po2) kept on dropping drastically while rewarming the patient.There was minimal blood loss.Two (2) units of blood was given to the patient.Procedure was completed successfully.The patient was on circulatory arrest for ~25 minutes during which time the blood in the oxygenator was being recirculated at ~1.0 lpm through a bypass line and manifold line.Upon rewarming, the po2 decreased and the pco2 increased (this was approximately 45-60 minutes before weaning off bypass).A co2 flush was being used at the sterile field and then stopped, but the pco2 did not correspondingly decrease.They increased the fio2 to 100% and sweep gas to 10 lpm.At that point, the act was ~394 seconds so 10,000 units of heparin was given.Prior to that, all act values were >500 seconds.The oxygen line was connected directly to an oxygen cylinder and delivered 100% o2, but it did not make a difference.The patient received 2 units of prbc and ventilation.This allowed the patient to wean off bypass without having to change out the oxygenator.The po2 then increased to ~500 mmhg.The blood was administered about the same time as the ventilation.It is uncertain if the blood made a significant difference, the ventilating or a combination of both mitigation attempts.The patient¿s hematocrit never dropped below 22% and was 24-25% most of the case.No clots were noticed in the circuit at anytime.

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.(b)(4).The sample was returned for evaluation; however, we could not confirm the infectious nature of the device; therefore, the device was not used.A retention sample whose fiber lot number is the same as that of the report lot number was obtained.Visual inspection did not find any anomalies, such as break, which would relate to insufficient gas transfer performance.The sample was tested for its gas transfer performance, no anomalies were revealed and the obtained values met the factory specifications.A definitive root cause could not be determined; therefore, this complaint is not confirmed.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Brand Name: NS FX25REC 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: 6914138
• MDR Text Key: 88164146
• Report Number: 1124841-2017-00201
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151791
• 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: 12/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Model Number: 3ZZ*FX25RECA
• Device Catalogue Number: N/A
• Device Lot Number: VF29
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2017
• 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
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 40 YR