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

Model Number 3CX*FX25RWC

Device Problem Gas Output Problem (1266)

Patient Problem Insufficient Information (4580)

Event Date 03/12/2021

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 oxygenators capacity to oxygenate the blood was severely reduced.The patient was on cpb for an aortic dissection and halfway through the case the oxygenators capacity to oxygenate the blood was severely reduced.Using an fio2 of 100% the customer was only seeing a po2 of 110-140mmhg.There was no pressure excursion across the membrane.Pre and post membrane pressures remained the same.The procedure was an ascending aorta replacement.The patient did not have any previous exposures to heparin.The patient arrested on induction.On cpb, within 10min of heparin administration.(b)(4) units of heparin was given plus (b)(4) units in the prime.Initial heparin given while patient was receiving cpr.First act was adequate for cpb commencement.No additional heparin was required throughout the case, and the patient's act remained well above required 480sec.The oxygenator was not changed out as it was maintaining adequate oxygenation for the patient.Fio2 was at 100% and sweep gas of 5l/min.

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 april 9, 2021.  upon further investigation of the reported event, the following information is new and/or changed: b5 (updated describe event or problem) g3 (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.

Event Description

Additional information received indicates that, there was no delay in the procedure, the surgery was completed successfully and it not known if there was a blood loss.

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: (date received by manufacturer).(indication that this is a follow-up report).(follow-up due to additional information).(identification of evaluation codes 4114, 3221, 4315).Type of investigation: 4114 - device not returned.Investigation findings: 3221 - no findings available.Investigation conclusions: 4315 - cause not established.The actual sample was not returned for evaluation, and the lot number was not provided; therefore, a complete investigation could not be performed and a root cause could not be determined.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: 11641765
• MDR Text Key: 245130896
• Report Number: 1124841-2021-00077
• 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: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 05/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3CX*FX25RWC
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Weight: 90