MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION STERILE FX15RWC W/ 4L RES; BLOOD GAS OXYGENATOR

Model Number 3CX*FX15RW40C

Device Problem Low Readings (2460)

Patient Problems Injury (2348); Blood Loss (2597)

Event Date 12/15/2020

Event Type  Injury  

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).

Event Description

The user facility reported to terumo cardiovascular that during cardiopulmonary bypass the p02 values dropped.Per user facility, the patient undergone replacement of the pulmonary artery valve following previous surgery.After 4 and a half hours of cec the parameters of p02 and pc02 were normal.They stated that the act values were >480 seconds, but the blood sitting stagnant in the pleural space for an unknown period of time (the blood was aspirated from the pleural space after ~4.5 hours) would not have had an act value of 480 seconds.About 2.2 liters of blood was aspirated from the pleura, intervention conducted with c02 delivery in the chest between 5-10 liters per minute.There was approximately 300ml of blood loss.The product was 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 january 6, 2021.Upon further investigation of the reported event, the following information is new and / or changed: b5: (added describe event or problem).D4: (additional device information - corrected lot number).D8: (device service by a third party).G3: (date received by manufacturer).G7: (indication that this is a follow-up report).H2: (follow-up due to correction).H6: (identification of codes 4739, 4614, 11).H6: component code: 4739 - gas exchanger.Health effect - impact code: 4614 - serious injury / illness / impairment.Investigation conclusions: 11 - conclusion not yet available.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 confirmed that act was performed after the suction from the pleura and it was 520.

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: g3 (date received by manufacturer) g6 (indication that this is a follow-up report) h2 (follow-up due to additional information) upon further investigation it was determined that the product was not tcv; therefore, there will be no further follow ups or investigation findings submitted.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Brand Name: STERILE FX15RWC 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: 11123671
• MDR Text Key: 225287184
• Report Number: 1124841-2021-00001
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 00699753450790
• UDI-Public: (01)00699753450790
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 03/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3CX*FX15RW40C
• Device Catalogue Number: N/A
• Device Lot Number: YE06
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 8 YR