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.

Event Description

Additional information has been received from the user facility.Act value just prior to stopping cpb was 678 sec.Act value 17 minutes off cpb was 543 sec.And 45 minutes off cpb was 483 sec.Protamine was administered 96 mins after coming off cpb.All blood collection to the cpb circuit from the operative field was ceased after 1/3 of protamine had been administered.The patient was re-heparinized, an act drawn 6 minutes later resulting in a post heparin act of 853 sec.Cpb was re-instituted 8 minutes after the last act sample was tested.While off cpb, for 135 minutes, the blood in the cpb circuit was being recirculated the entire time via purges and 1/4" recirculation line, with blood collected from the field being returned at the rate at which is was being collected.All blood being returned was well oxygenated.There were no indications of issues within the circuit during this time.

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 14, 2021.Upon further investigation of the reported event, the following information is new and/or changed: g6 (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.

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 expiration date); g3 (date received by manufacturer); g6 (indication that this is a follow-up report); h2 (follow-up due to additional information); h4 (device manufacture date); h6 (identification of evaluation codes 3331, 4114, 3221, 4315).Type of investigation #1: 3331 - analysis of production records.Type of investigation #2: 4114 - device not returned.Investigation findings: 3221 - no findings available.Investigation conclusions: 4315 - cause not established.The affected complaint sample was not returned for investigation.A thorough investigation of this complaint cannot be performed, and a definitive root cause of the reported incident cannot be determined.Production records were reviewed with no anomalies noted.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

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: d9 (device availability added date returned to manufacturer).G3 (date received by manufacturer).G6 (indication that this is a follow-up report).H2 (follow-up due to additional information).H3 (device evaluation anticipated by manufacturer 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.

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: g3 (date received by manufacturer) g6 (indication that this is a follow-up report) h2 (follow-up due to additional information and device evaluation) h3 (device evaluated by manufacturer) h6 (identification of evaluation codes 10, 3331, 213, 67) 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 investigation of the case could not be performed.Since no anomaly was found in the manufacturing record, it was inferred that the amount of oxygen supplied was insufficient for the amount of oxygen consumed by the patient under circ conditions at the time of the event.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• 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

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• 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
• Initial Date Manufacturer Received: 09/28/2021
• Initial Date FDA Received: 10/14/2021
• Supplement Dates Manufacturer Received: 11/18/2021; 12/09/2021; 01/06/2022; 02/14/2022
• Supplement Dates FDA Received: 12/08/2021; 12/15/2021; 01/25/2022; 02/17/2022
• 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
• Patient Sequence Number: 1