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

Model Number 3CX*FX25REC

Device Problem Decrease in Pressure (1490)

Patient Problem Death (1802)

Event Date 09/25/2020

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 p02 dropped below 250.Per clinical specialist information was received from the user that the patient was in for an avr.The patient presented in renal failure and respiratory failure and was deemed very sick was transferred to a cvicu.The patient¿s post op course was apparently complicated by sepsis, continuing respiratory failure and experienced a cardiac arrest in the unit.It was determined that one of the leaflets on his mitral valve was dysfunctional exacerbating his respiratory failure.This took the patient emergently back to the or for reoperation for the mitral valve.The metabolic condition of the patient during the second procedure was awful.The perfusionist was giving an amp of bicarb with every blood gas drawn.The metabolic acidosis was unrelenting.User facility add, both oxygenators utilized during this procedure made it 90+ minutes before experiencing clinical performance issues.The po2 at change out of the first one was in the forty to fifty range with an fio2 of 100%.All normal troubleshooting points were tried; ( checked to be sure they had flow, checked and replaced the gas blender with an o2 tank just to rule this out.The patient temperature was 33 to 34 degrees c at time of change out that took out 5 minutes ).After change out the second oxygenator performed as expected for approximately 90+ minutes before starting to exhibit performance issues in the face of severe metabolic acidosis continuing.Per user facility they were having difficulty maintaining their heparin protocols, the patient was requiring large doses of heparin.Acts sounded like they were above 350 seconds for the case.Per user the patients ongoing sepsis, respiratory failure, potential heparin resistance and white cell activation complicated by a cytokine storm.All very real possibilities for a coating event to occur.The patient experienced multiple exposures to heparin in a short time.Initially, the patient woke up after the mitral procedure and was following commands.He passed either late thursday or early friday morning.

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 16, 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, 213, 67).Method code#1: 10 - testing of actual/suspected device.Method code #2: 3331 - analysis of production records.Results code: 213 - no device problem found.Conclusions code: 67 - no problem detected.The actual sample, after having been arisen and dried, was tested for its gas transfer performance in accordance with the factory's inspection protocol.As a result, no anomalies were revealed in the gas transfer performance of the actual sample, with the obtained values meeting the factory's control criteria.The investigation result verified that the actual sample, after having been rinsed, was the normal product with no issue in the gas transfer performance.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: b5: (describe event or problem added new information).G4: (date received by manufacturer).G7: (indication that this is a follow-up report).H2: (follow-up due to correction).All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

Event Description

New information was received indicating that the po2 dropped below 50 instead of 250.

• 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
• MDR Report Key: 10691897
• MDR Text Key: 211724786
• Report Number: 1124841-2020-00240
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 00699753450820
• UDI-Public: (01)00699753450820
• 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
• Report Date: 12/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: 3CX*FX25REC
• Device Catalogue Number: N/A
• Device Lot Number: YD02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SORIN S-5; SORIN S-5
• Patient Outcome(s): Death
• Patient Age: 44 YR