MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION STERILE FX15RWC W/ 3L RES; BLOOD GAS OXYGENATOR

Model Number 3CX*FX15RW30C

Device Problem Use of Device Problem (1670)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 04/05/2023

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.For this reason, terumo references evaluation conclusion code 11.H6: component code: 4739 - gas exchanger.Health effect - impact code #1: 4614 - serious injury/ illness/ impairment.Health effect - impact code #2: 4604 - delay to treatment/ therapy.Health effect - clinical code: 1888 - hemorrhage/bleeding.Medical device problem code: 1670 - use of device problem.Investigation findings: 3233 - results pending completion of investigation.Investigation conclusions: 11 - conclusion not yet available.

Event Description

The user facility reported to terumo cardiovascular that during cardiopulmonary bypass, the oxygenator failed to the full extent.Per subsidiary, there was no color change in the arterial line after the hlm had started.After 5 minutes, gas calibration confirmed the suspicion of an oxygenator failure.Patient's year of birth: (b)(6).The continuation of the procedure was delayed by 5 minutes.There was approximately 300 ml 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 may 5, 2023.Upon further investigation of the reported event, the following information is new and/or changed: b5 (describe event or problem).D3 (manufacturer - corrected email address).D4 (additional device information - added expiration date).G1 (all manufacturer - name, email address and phone number).G3 (date received by manufacturer).G6 (indication that this is a follow-up report).H2 (follow-up due to additional information, device evaluation and correction).H3 (device evaluated by manufacturer).H4 (device manufacture date).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 found that there was no anomaly such as breakage.The amount of oxygen transfer and carbon dioxide gas removal were measured according to the product inspection procedure.It was confirmed to meet the factory's specification.Based on the investigation result, the gas transfer performance of the actual sample after rinsing met the factory's specification and no anomaly was found in the manufacturing records.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

Event Description

New information from the clinical specialist indicates that the perfusionist of this complaint stated that upon initiation of bypass and for the first 5 minutes of bypass, the terumo fx15 oxygenator did not produce a bright red color of the blood out of the arterial port/line.The sweep gas and fio2 settings were adjusted to maximum levels.The perfusionist did an arterial blood gas on an il blood gas analyzer at the 5-minute mark and indeed it revealed a po2 of 21mmhg and an arterial saturation of only 25 %.The pco2 also was elevated at 59mmhg with a ph of 7.25, below normal.This indicated no function of the oxygenator.The heparinization in this case seemed adequate.The patient was given 10,000 iu of heparin and 50cc of albumin in the prime of the fx15 oxygenator and the first act value was 480 seconds.

• Brand Name: STERILE FX15RWC 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: douglas patton ; 125 blue ball road; elkton, MD 21921 ; 7346634145
• MDR Report Key: 16876660
• MDR Text Key: 314642260
• Report Number: 1124841-2023-00107
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 00699753450783
• UDI-Public: (01)00699753450783
• 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: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/09/2023

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: Other
• Device Model Number: 3CX*FX15RW30C
• Device Catalogue Number: N/A
• Device Lot Number: 2F02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/11/2023
• Initial Date FDA Received: 05/05/2023
• Supplement Dates Manufacturer Received: 06/08/2023
• Supplement Dates FDA Received: 06/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/24/2022
• 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
• Patient Weight: 51 KG