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

Model Number 3CX*FX25RWC

Device Problems Insufficient Flow or Under Infusion (2182); Defective Device (2588)

Patient Problems Injury (2348); Blood Loss (2597); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/26/2020

Event Type  Injury  

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 have confirmed this failure occurred prior to bypass and was detected by the perfusionists who uses bottles oxygen to test during setup.He also spoke to the clinical specialist and the two perfusionists who were on the case.The bypass was initiated and the oxygenator failed within 5 minutes of initiation.Perfusion came off pump, anesthesia ventilated the patient and they changed out the oxygenator without incident.The account routinely tests every oxygenator prior to bypass.This oxygenator was tested after the failure in the pump room using the same method and it was confirmed that it would not oxygenate.Also, as per the sales associate, there was a delay for 10 minutes and 800cc of blood loss.As per the clinical specialist, the account routinely tests every oxygenator prior to bypass for gas exchange using the cdi 550.The oxygenator tested okay prior to cpb but when they went on bypass, the blood did not turn bright red, it got darker.The initial sweep gas was 3.0 lpm , fio2 was 65% at ~4 lpm blood flow.The perfusionist turned the sweep gas to 8 lpm and fio2 to 100% but blood was still dark, they checked all connections, hooked up an oxygen tank to the oxygenator and that did not resolve the problem so they decided to change out the entire hlm.Additionally, the patient had coronary artery disease, was a smoker and with previous exposure to heparin.The procedure performed was a cabg (coronary artery bypass grafting).On bypass approximately 5 minutes then changed out entire heart-lung machine, not just the oxygenator.Patient¿s heart was still beating, anesthesia ventilated patient so there was adequate metabolic support of the patient during the change out of the heart-lung machine.The initial dose of heparin administration was approximately 5 minutes in between the initiation of the cpb.The blood gas values pre and during cpb prior to the oxygenator changed out was; 0901 7.47, 32, 171, 22, 0; 0927 7.43, 38, 87, 25, 1; 1000 7.42, 34, 426, 22, -2 and the act values prior to and during cpb was at 642.The temperature of the patient at the time of the oxygenator changed out was 36 degrees.Venous saturation was low, and venous blood was very dark.The hgb and hct values were, 40% hematocrit, hemoglobin 13.5 at initiation of cpb.Heparin level was also monitored at 3.0.The product was changed out.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 november 16, 2020.Upon further investigation of the reported event, the following information is new and/or changed: h6 (identification of evaluation codes 4739, 4614, 4604, 4582, 2182, 10, 3331, 213, 67).Components code: 4739 - gas exchanger.Health effect - impact code #1: 4614 - serious injury/ illness/ impairment.Health effect - impact code #2: 4604 - delay to treatment/ therapy.Health effect - clinical code: 4582 - no clinical signs, symptoms or conditions.Medical device problem code: 2182 - insufficient flow or under infusion.Type of investigation #1: 10 - testing of actual/suspected device.Type of investigation #2: 3331 - analysis of production records.Investigation findings: 213 - no device problem found.Investigation conclusions: 67 - no problem detected.The returned sample was visually inspected upon receipt with no break or other obvious anomaly that would lead to decrease in oxygenation performance.After having been rinsed and dried, it was then tested for the o2 transfer volume and co2 removal volume in accordance with the factory's inspection protocol.No anomalies were revealed in the oxygenation performance of the actual sample, with the obtained values meeting the factory's control criteria.During the performance test, the arterial blood color was confirmed to be brighter that the venous blood color.The investigation result verified that the actual sample after having been rinsed, was the normal product with no issue in the oxygenation performance.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: 10848610
• MDR Text Key: 216839608
• Report Number: 1124841-2020-00262
• 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
• Report Date: 01/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2020
• Is this an Adverse Event Report?: Yes
• 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: 10/27/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other