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

Model Number 3CX*FX15RW40C

Device Problems Leak/Splash (1354); Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/15/2021

Event Type  malfunction  

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 prior to cardiopulmonary bypass, during prime, they noticed bubbling inside the sock while recirculating the prime.No known impact or consequence to patient.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 july 1, 2021.Upon further investigation of the reported event, the following information is new and/or changed: d4 (additional device information - added expiration date), g3 (date received by manufacturer), g6 (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, 11, 3331, 3259, 25).Type of investigation #1: 10 - testing of actual/suspected device.Type of investigation #2: 11 - testing of device from same lot/batch retained by manufacturer.Type of investigation #3: 3331 - analysis of production records.Investigation findings: 3259 - improper physical structure.Investigation conclusions: 25 - cause traced to manufacturing.The affected sample was disassembled and found that the small o-ring on the venous inlet had been misseated leading to the o-ring being ripped.A representative retention sample was inspected and tested to confirm an appropriately seated o-ring.The retention sample was setup in a water circuit with flow through the unit, when forward flow was stopped, prime was not lost in the circuit.The o-ring creates an air-tight seal to prevent air from being drawn into the reservoir during circulation.A general training has been conducted with production staff to raise awareness to this issue.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: 12099735
• MDR Text Key: 261540215
• Report Number: 1124841-2021-00162
• 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,health
• Type of Report: Initial,Followup
• Report Date: 08/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2024
• Device Model Number: 3CX*FX15RW40C
• Device Catalogue Number: N/A
• Device Lot Number: ZD15
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1