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

Model Number 3CX*FX25REC

Device Problem Gas Output Problem (1266)

Patient Problem Lactate Dehydrogenase Increased (4567)

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.

Event Description

The user reported to terumo cardiovascular during cardiopulmonary bypass the performance of the oxygenator decreased to po2 of 90 after 6. 5 hours of bypass. As per user facility, the case ended up being a redo aortic root replacement/pa conduit implantation. All acts were kept in the 400-500 range, act right before change out was 416. Additional heparin administration on bypass was limited due to sufficient acts most of the case. Not much heparin resistance was observed. As per ccp he was told pre-cpb and early cpb lactate was elevated, at least 10. The patient had pao2s in the 300-400s at about 50 fio2 at the peak cold set point of 28 degrees c, also the sweep averaged around 5 with a heavy -10 base deficit during this coldest point and a higher 40s paco2. Lactate now 14. It was during rewarm that the pao2 started to drop with great fio2 increase to eventually 100 percent. The sweep also had to eventually be raised to 9-10 with climbing paco2 values. Lactate also rose throughout the case with the last lactate being 20 before patient left the room. At pao2 of about 95-100 and fio2/ sweep maxed, all connections of cpb ventilation were checked then the oxygenator was connected directly to tank, different arterial sample locations were drawn and radial which reflected similar values. Pao2 coasted at 85 right before the circuit change out occurred. Pao2 rose to 500s with new circuit. The last venous saturation that was observed before circuit change was low 60s and patient pre change out was about 10-11 hgb and post change out was low 9 hbg. For the change out, the new circuit was decided to be primed with 2 rbcs and 1 of ffp, chasing plasmalyte prime volume out, the change out occurred during rewarm period at the 32-34 degree mark. In addition according to ccp, the high complexity of the case resulting in a longer bypass time (circuit change out occurred at the 6 hour and 40min mark) and the advanced lactate/ metabolic and respiratory acidosis throughout, the oxygenator had an excessively high settings for a long period of time which were the main factors. After draining the old circuit, no clots were visible anywhere around the oxy nor the reservoir. There was minimal blood loss. There was 1-2 minute delay. The product was changed out. The surgery was completed successfully.

• 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 (Section G): SAME
• Manufacturer Contact: jamie quinlan ; 125 blue ball road; elkton, MD 21921 ; 8002837866
• MDR Report Key: 11826411
• MDR Text Key: 252017790
• Report Number: 1124841-2021-00111
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/25/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 05/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: 3CX*FX25REC
• Device Catalogue Number: N/A
• Device Lot Number: ZD01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 06/25/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial