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

Model Number 3CX*FX25REC

Device Problem Use of Device Problem (1670)

Patient Problem Blood Loss (2597)

Event Date 07/21/2017

Event Type  Injury  

Manufacturer Narrative

The actual sample was not returned to the factory for evaluation.The retention sample of the involved product and lot number was verified to be normal product.Visual inspection did not find any anomaly, such as break in the appearance.The retention sample was tested for its gas transfer performance in accordance to the factory's shipping inspection and no anomalies were revealed.Root cause could not be identified, however, there may have been some physiological factors contributing to the event.(b)(4).Method codes: device from reserve sample evaluated.Visual inspection.Flow testing.Results code: no failure detected.Conclusions codes: unable to confirm complaint.Device not returned.All available information has been placed on file in quality management for appropriate tracking, trending and follow-up.

Event Description

The user facility reported to terumo cardiovascular that during cardiopulmonary bypass (cpb), the oxygenator had a gas exchange failure.Serious injury was noted.Product was not changed out.Surgery was not completed successfully.A whitish milky layer on top of the layer of blood was noticed when it was sitting idle in the chamber of the cardioplegia device.They had problems oxygenating the patient in the intensive care unit ( icu) so they tried nitric oxide therapy but it did not help.The patient had been stable from a cardiac perspective but then went into full blown congestive heart failure and pulmonary edema in the icu post-operatively and they could not ventilate him so he was taken back to the operating room (or).Patient had fluid coming out of the endotracheal tub; estimated that they sucked out about two liters of fluid out of the patient's lungs.Patient was put back on cpb while waiting for a different facility's team to arrive to put the patient on ecmo.The patient was placed on cpb with an fx25rec, patient oxygenation improved, but lactate levels were higher than measurable.The po2 values steadily decreased and the pco2 values increased over time from 2200 to 0140.At 0140 the po2 and pco2 were in the 50s so they partially filled up the heart and had anesthesia start ventilating to help oxygenate the patient.The po2 increased to 73 at 0155.Once the patient was placed on the ecmo circuit, gas exchange significantly improved with the po2 in the 400s and pco2 in the mid 30s.Clinician indicated there may have been some protein/platelet activation occurring which was clogging the fibers in the oxygenator resulting in the decline in gas exchange performance.The fiber bundle was clean (no fibrin or clot on the fibers) when the blood was sent cell saver.Act values were >1000 most of the time; the last act before the patient was transported was 635 when on ecmo.Approximately 24 hours after the patient was transferred for ecmo, the patient was still on the original ecmo circuit.The patient's creatinine was extremely high and the patient was in renal failure.

• Brand Name: STERILE 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: 6870669
• MDR Text Key: 86426079
• Report Number: 1124841-2017-00191
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 3CX*FX25REC
• Device Catalogue Number: N/A
• Device Lot Number: VF22
• Other Device ID Number: (01)00699753450820
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/06/2017
• Initial Date FDA Received: 09/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2017
• 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