MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION STERILE FX25RWC W/ RES; BLOOD GAS OXYGENATOR

Model Number 3CX*FX25RWC

Device Problem Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/09/2020

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.(b)(4).

Event Description

The user facility reported to terumo cardiovascular that during cardiopulmonary bypass, the oxygenator failed to oxygenate.As per the distributor, they got help form the second perfusionist and found no setup errors.He tried everything to get the po2 above 70.Open recirc and got it up to 115.The oxygenator was changed out and po2 is in 400.No consequences or impact to patient.There was a delay for approximately 15 minutes.Product was changed out.Procedure was completed successfully.

Manufacturer Narrative

This follow-up report is submitted to fda in accord with applicable regulations.Upon further investigation of the reported event, the following information is new and/or changed: d4 (additional device information added exp date).G4 (date received by manufacturer).G7 (indication that this is a follow-up report).H2 (follow-up due to additional information and device evaluation).H3 (device evaluated by manufacturer).H4 (device manufacture date).H6 (identification of evaluation codes 10, 3331, 213, 67).Method code #1: 10 testing of actual/suspected device.Method code #2: 3331 analysis of production records.Results code: 213 no device problem found.Conclusions code: 67 no problem detected.The returned sample was visually inspected upon receipt with no anomalies that could lead to the failure in oxygenation.After having been rinsed and dried, it was then tested for its gas transfer performance in accordance with the factory's inspection protocol.No anomalies were revealed in the gas transfer performance of the actual sample with the obtained values meeting the factory's control criteria.Review of the manufacturing record and the incoming inspection record of the involved product / lot number combination confirmed there were no anomalies in them.The evaluation results verified that the actual sample, after having been rinsed, was the normal product with no issue is the gas transfer performance.All available information has been placed on file in quality management for appropriate tracking, trending and follow-up.

Event Description

Additional information received from the perfusionist indicates that, they were on pump at 10:27 blood appeared dark, cdi reading p02 of 77.Double checked settings, gas lines, opened recirc line.Drew gas and act sample and notified surgeon of situation.Oxygenation of patient was evaluated.Asked that additional perfusionist come into the room, scanned for mechanical issues, none found.Recirc appeared to be improving oxygenation, drew gas, p02 coming up.Stayed warm, announced we could not cross clamp aorta, still evaluating.With second perfusionist still in room, closed recirc to test function and p02 reading on cdi dropped rapidly.At that point, they needed to wean off bypass.Still warm, anesthesia started ventilating and we weaned off in a normal fasion.Patient very stable with normal pressures and ekg.No clot seen anywhere in system.Reservoir clean, so decided would change out oxygenator.The oxygenator was changed out, with the assistance of second perfusionist, in a sterile well controlled manner.Deaired and recirculated.Announced we were ready to initiate bypass.Back on at 1042, arterial line bright red, gas confirmed p02 of 337.Proceeded to arrest heart and complete bypass grafting with no further complications.At no time was the patient without flow or pressure.Weaned off within minutes under controlled process.Patient was discharged from the hospital after an expected recovery period.The patient was on a heparin drip which was stopped the morning of surgery - heparin stopped at 0630, patient went to or at 0700.35,000 units of heparin at 0910, act was 314 at 0914, 10,000 units heparin given; act was 395 at 0936, 20,000 units heparin given; act was 357 at 0945; act = 424 at 1002 - cannulated patient for cpb.There was 10,000 units of heparin in the pump prime.On cpb at 1027, act was 475 at 1031, act was 435 at 1055.Abg at 1031: ph = 7.35, pco2 = 51.8, po2 = 77.There's no recorded information on the pump record indicating the blood flow and sweep gas rate prior to 1100 and prior to the oxygenator change out.The patient was 135 kg (187 cm) with a bsa of 2.56.They gave thrombate at 1105, ffp at 1108 and additional heparin at 1110 - after the oxygenator was changed out.It is not recorded on the pump record that the oxygenator was changed out.

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 28, 2020.Upon further investigation of the reported event, the following information is new and/or changed: a2 (added patient's age); a3 (added patient's sex); a4 (added patient's weight); b5 (updated describe event or problem); b6 (added relevant tests/laboratory data); b7 (added other relevant history, including preexisting medical conditions); g4 (date received by manufacturer) ; g7 (indication that this is a follow-up report); h2 (follow-up due to additional information).A second follow-up will be submitted upon completion of the investigation and/or submission of new information, thus tcvs references conclusions code 11.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Brand Name: STERILE FX25RWC W/ RES
• Type of Device: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• MDR Report Key: 10748368
• MDR Text Key: 213450674
• Report Number: 1124841-2020-00247
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 00699753450837
• UDI-Public: (01)00699753450837
• Combination Product (y/n): N
• PMA/PMN Number: K151791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup,Followup
• Report Date: 12/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: 3CX*FX25RWC
• Device Catalogue Number: N/A
• Device Lot Number: YH13
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 135