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

Model Number 3CX*FX25RWC

Device Problem Leak/Splash (1354)

Patient Problems Death (1802); Aortic Dissection (2491); Blood Loss (2597)

Event Date 11/28/2019

Event Type  Death  

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).

Event Description

The user facility reported to terumo cardiovascular that during cardiopulmonary bypass, the oxygenator was leaking water and methylene blue, did not leak blood.The pump was setup before the case and covered.It was primed as the patient was coming into the room.The oxygenator ran for about 30 minutes until it started to drip.At the same time the po2 dropped from 300 to about 45 and the unit was successfully changed out.The patient was (b)(6) years old.The product was changed out.There was a delay for 3 minutes.There was a minimal blood loss.The procedure was not completed successfully as the patient expired.

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 december 18, 2019.  upon further investigation of the reported event, the following information is new and/or changed: d10 (device availability - corrected date returned to manufacturer); g4 (date received by manufacturer); g7 (indication that this is a follow-up report) ; h2 (follow-up due to correction and 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.A third 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: h6 (identification of evaluation codes 10, 11, 3331, 213, 67, 4315).Method code #1: 10 - testing of actual/suspected device.Method code #2: 11 - testing of device from same lot/batch retained by manufacturer.Method code #3: 3331 - analysis of production records.Results code: 213 - no device problem found identified.Conclusions code #1: 67 - no problem detected.Conclusions code #2: 4315 - cause not established.The affected sample was returned and visually inspected upon receipt.No anomalies found such as breakage to the blood inlet port housing, which could lead to breakage.Additionally, it was confirmed that the fiber cross section on the gas inlet side and the gas outlet side turned red.After having been rinsed, the blood channel of the sample was filled with saline solution to improve visibility, then a pressure of 25kgf/cm2 was applied.No leak was observed.Review of device history record and incoming inspection record of the actual sample confirmed no indications of anomalies in them.A search of the complaint file found no other similar report with the involved product code/lot number combination.The evaluation result shows no anomaly that could lead to the leakage were found on the actual sample.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: 9491097
• MDR Text Key: 171879523
• Report Number: 1124841-2019-00335
• 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,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Model Number: 3CX*FX25RWC
• Device Catalogue Number: N/A
• Device Lot Number: XH15
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 28 YR