MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION NS FX15REC W/3L RES; BLOOD GAS OXYGENATOR

Model Number 3ZZ*FX15RE30CA

Device Problem Leak/Splash (1354)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 09/02/2022

Event Type  Injury  

Event Description

The user facility reported to terumo cardiovascular that after cardiopulmonary bypass, there was leak in the oxygenator.There was 200ml of blood loss.

Manufacturer Narrative

Terumo has received the device for evaluation; however, 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).

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 september 20, 2022.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

New information received that there was no known patient injury to the patient at that time.

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: 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 finding: 213 - no device problem found, investigation conclusions: 67 - no problem detected.The actual sample was visually inspected and did not find any anomaly such as breakage.After rinsing and drying the actual sample, the water channel of the heat exchanger was filled with colored water, the water outlet port side was clamped, and the air pressure of 3kgf/cm3 was applied from the water inlet port side into the water channel to check the leakage.No leakage was found.The blood channel was then filled with colored saline solution, the blood outlet port side was clamped, and air pressure of 2kgf/cm2 was applied from the blood inlet port side into the blood channel and no leakage was found.The investigation result verified that no anomaly leading to leakage was found in the actual sample after rinsing.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Brand Name: NS FX15REC W/3L 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: 15456011
• MDR Text Key: 300245282
• Report Number: 1124841-2022-00154
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151389
• 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
• Report Date: 11/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3ZZ*FX15RE30CA
• Device Catalogue Number: N/A
• Device Lot Number: 2G27
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/02/2022
• Initial Date FDA Received: 09/20/2022
• Supplement Dates Manufacturer Received: 09/27/2022; 11/09/2022
• Supplement Dates FDA Received: 10/20/2022; 11/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2022
• 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
• Patient Outcome(s): Other