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

Model Number 3ZZ*FX25RECA

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/22/2021

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. (b)(4).

Event Description

The user facility reported to terumo cardiovascular that during cardiopulmonary bypass, the oxygenator failed to oxygenate. Emergent return to cpb due to failing abp & arterial saturations. The patient was weaned from bypass at 1516 with anesthesia managing oxygenation, ventilation, and blood pressure while the change out was completed. Total time required for changeout from separation to reinstitution of cpb was approximately 5 mins. Cpb was reinstituted at 1521 without incident. Post procedure, the failing oxygenator was visually inspected and there were no visual signs of gross clot observed. After washout, there appeared to be some evidence of fibrin formation/deposition on the fiber bundle, but no gross clot visible. The residual blood flowed freely from the oxygenator's ports. During the failure, a secondary gas source was used (oxygen cylinder) to confirm that the pumps gas supply was not the issue. Failure was confirmed via arterial blood gas. It is important to note that at no time was there any change in flow/pressure within the circuit or evidence of clotting within the venous reservoir or centrifugal pump head. No known impact or consequence to patient. Product was changed out with approximately 5 minutes delay. Procedure was completed successfully.

• 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 (Section G): SAME
• Manufacturer Contact: jamie quinlan ; 125 blue ball road; elkton, MD 21921 ; 8002837866
• MDR Report Key: 12632815
• MDR Text Key: 276471184
• Report Number: 1124841-2021-00237
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/17/2022

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 10/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 3ZZ*FX25RECA
• Device Catalogue Number: N/A
• Device Lot Number: ZC01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial