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

Model Number 3CX*FX15RW40C

Device Problems Use of Device Problem (1670); Insufficient Flow or Under Infusion (2182)

Patient Problems Hypoxia (1918); Injury (2348); Blood Loss (2597)

Event Date 11/09/2020

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 oxygen saturation fell and the patient turned hypoxic.There was a blood loss of 200 ml.The product was changed out.There was a delay around 15-20 minutes.Procedure 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 04, 2017.  upon further investigation of the reported event, the following information is new and/or changed: 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.

Event Description

Additional information received from the subsidiary perfusionist states that, while they were on cardiopulmonary bypass (cpb) the arterial line was not bright and also the patient got desaturated, then they checked the arterial blood gas (abg) and found that the saturation and po2 levels are low.The entire circuit and gas supply was checked and found alright.So they decided to change the oxygenator and after changing oxygenator everything was normal.Additionally, the patient was receiving clexane for one week one month before the surgery; ejection traction:48%.

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 4739, 4604, 4614, 1918, 2182, 10, 3331, 213, 67).Component code: 4739 - gas exchanger.Health effect - impact code #1: 4604 - delay to treatment/ therapy.Health effect - impact code #2: 4614 - serious injury/ illness/ impairment.Health effect - clinical code: 1918 - hypoxia.Medical device problem code: 2182 - insufficient flow or under infusion.Type of investigation #1: 10 - testing of actual/suspected device.Type of investigation #2: 3331 - analysis of production records.Investigation findings: 213 - no device problem found.Investigation conclusions: 67 - no problem detected.The actual sample was visually inspected upon receipt with no anomaly including a breakage that could lead to the gas exchanged failure.After rinsing and drying of the returned sample, the amount of oxygen transfer and carbon dioxide gas removal were measured according to the product inspection procedure manual.It was confirmed to meet the factory's specification and no anomaly was found.During the gas transfer performance test, it was confirmed that the color of the arterial blood was found to be bright red compared to the color of venous blood.Based on the investigation results, no anomaly was found in the gas transfer performance of the actual sample after rinsing.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: 10898227
• MDR Text Key: 218258361
• Report Number: 1124841-2020-00271
• 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: 01/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2020
• Device Model Number: 3CX*FX15RW40C
• Device Catalogue Number: N/A
• Device Lot Number: WA22
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 45