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

Model Number 3CX*FX25REC

Device Problem Leak/Splash (1354)

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

Event Date 09/16/2022

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).Investigation findings: results pending completion of investigation.Investigation conclusions: conclusion not yet available.

Event Description

The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass during prime, there was a leak at the purge line.Per facility, they clamped it off and moved the sampling line.*no known impact or consequence to patient.*the product was not changed out.*the surgery 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 october 6, 2022.Upon further investigation of the reported event, the following information is new and/or changed: h6 (identification of evaluation codes 11, 3331, 4114, 3259, 4307).Type of investigation #1: 11 - testing of device from same lot/batch retained by manufacturer.Type of investigation #2: 3331 - analysis of production records.Type of investigation #3: 4114 - device not returned.Investigation finding: 3259 - improper physical structure.Investigation conclusions: 4307 - cause traced to component failure.The affected sample was not returned.However, a photo was provided showing a leak at the arterial pigtail port which confirms this event.A representative retention sample was inspected to confirm no visual damage or anomalies with the arterial pigtail.All capiox units are 100% visually inspected at several points in the production process.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• 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: 15550773
• MDR Text Key: 306830679
• Report Number: 1124841-2022-00157
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 00699753450820
• UDI-Public: (01)00699753450820
• 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
• Report Date: 11/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3CX*FX25REC
• Device Catalogue Number: N/A
• Device Lot Number: 2K01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2022
• 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