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

Model Number 3ZZ*FX15RW40CA

Device Problem Obstruction of Flow (2423)

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

Event Date 05/21/2019

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, there was a buildup in the oxygenator.As per the customer, there was something building up on the oxygenator such that it became flow restricted overtime.They were on bypass at 1028, initial venous return, flow, pressure were good.After the x-clamped at 1029, the flow was down slightly and pressure went up.They increased revolutions per minute (rpm) to increase the flow, however, the line pressure was too high.They asked the surgeon to reposition x-clamp during the initial plegia run, and the pressure/flow returned to initial good levels.During the first distal art line, flow was decreasing and pressure was decreasing, flow decreased to the patient.However, venous sat was still 70%, but down and rpm was turned to 3600 maximum with only 3l/m flow to patient.No problem on the x-clamp upon re-check.There was still no improvement in ability to flow after trying the hand-crank, and the flow to patient continues to decrease.They asked surgeon to changed arterial cannula, gave subsequent dose of plegia at 1053, however, there was no changes on the flow and pressure.They were off bypass for 10 minutes to change the oxygenator, with patients temperature of 28 degree celsius.They resumed bypass, and flow/pressure issues were resolved as well as oxygenation.They re-warmed at 1135, x-clamp off at 1205 with normal sinus rhythm.Successfully weaned from bypass at 1226.Patient was discharge without issues.  there was a blood loss of 500 cc.Product was changed out.Procedure 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 june 10, 2019.Upon further investigation of the reported event, the following information is new and/or changed: 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.

Manufacturer Narrative

This follow-up report is submitted to fda in accord with applicable regulations.G7 (indication that this is a follow-up report).H6 (identification of evaluation codes 10, 3331, 114, 4315).Method code #1: 10 - testing of actual/suspected device.Method code #2: 3331 - analysis of production records.Result code: 114 - operational problem identified.Conclusions code: 4315 - cause not established.The actual sample was visually inspected upon receipt and no anomalies in appearance were noted.The actual sample was rinsed, dried and built into a circuit.Bovine blood was circulated in the circuit, while the pressure drop was determine at each flow rate.The values obtained confirmed to meet factory's specification and no obstruction was noted.The actual sample was flushed with water and no clot were found.However a review of the photo provided confirmed that clots had formed around the oxygenator.The root cause for the issue could not be determined with the information available.The product met factory specification.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Brand Name: NS 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: 8684819
• MDR Text Key: 147523117
• Report Number: 1124841-2019-00164
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• PMA/PMN Number: K151389
• 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: 08/15/2019

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: Health Professional
• Device Expiration Date: 11/30/2021
• Device Model Number: 3ZZ*FX15RW40CA
• Device Catalogue Number: N/A
• Device Lot Number: WP31
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/22/2019
• Initial Date FDA Received: 06/10/2019
• Supplement Dates Manufacturer Received: 06/14/2019; 08/13/2019
• Supplement Dates FDA Received: 07/02/2019; 08/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MEDTRONIC HMS PLUS.; MEDTRONIC HMS PLUS
• Patient Outcome(s): Other
• Patient Age: 70 YR
• Patient Weight: 126