MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION STERILE NX19RE W/ 4L RES; BLOOD GAS OXYGENATOR

Model Number 3CX*NX19RE

Device Problem Leak/Splash (1354)

Patient Problems Death (1802); Heart Failure (2206)

Event Date 01/29/2020

Event Type  Injury  

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 foaming.Per user facility, the case was an aortic aneurysm dissection and they were on bypass for 3.5 hours then another 1 to 1.5 hours off again and then on for 15-20 minutes.The oxygenator was foaming and the end of the case, p02 dropped, they transferred to extracorporeal membrane oxygenation (ecmo), which was necessary due to the patient's right heart failure.The patient expired at a later date.There was slight blood colored plasma at the end.The product was not changed out but they did add a fx15 oxygenator into the circuit to have as a backup, (it was not used).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 february 18, 2020.Upon further investigation of the reported event, the following information is new and/or changed: d4: (additional device information: added expiration date).G4: (date received by manufacturer).G7: (indication that this is a follow-up report).H2: (follow-up due to additional information and device evaluation).H3: (device evaluated by manufacturer).H4: (device manufacture date).H6: (identification of evaluation codes 10, 3331, 4210, 4315).Method code #1: 10 - testing of actual/suspected device.Method code #2: 3331 - analysis of production records.Results code: 4210 - leakage/seal.Conclusions code: 4315 - cause not established.The affected sample was returned and visually inspected upon receipt with no anomalies noted.Sem analysis and review of perfusion records has been conducted and has been unsuccessful in determining the cause of this event.The unit was dissected and dyed with nile blue a.This is a water-soluble dye that has the ability to stain neutral fats and phospholipids in different colors.This analysis showed that no red blood cells were remaining in the unit, and that the substances are derived from plasma.An engineering investigation has been initiated to determine a root cause.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Brand Name: STERILE NX19RE W/ 4L RES
• Type of Device: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• MDR Report Key: 9721858
• MDR Text Key: 188528845
• Report Number: 1124841-2020-00035
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 00699753450868
• UDI-Public: (01)00699753450868
• Combination Product (y/n): N
• PMA/PMN Number: K180950
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2020
• Device Model Number: 3CX*NX19RE
• Device Catalogue Number: N/A
• Device Lot Number: XL28
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 51 YR
• Patient Weight: 91