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

Model Number 3CX*FX15RW40C

Device Problem Device Damaged Prior to Use (2284)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/15/2019

Event Type  malfunction  

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 out of box, the venous port of the new oxygenator was damaged.The oxygenator was used throughout the case.No known impact or consequence to patient.The product was not 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 nov 1, 2019.(b)(4).The affected sample was not returned for review.However pictures were provided with the complaint which confirmed damage to the venous inlet port.Retention sample from variety of lot numbers were reviewed with no anomalies noted.The process steps were reviewed and evaluated for improvement opportunities for handling during manufacture.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: 9269064
• MDR Text Key: 165494012
• Report Number: 1124841-2019-00304
• 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
• Report Date: 11/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Model Number: 3CX*FX15RW40C
• Device Catalogue Number: N/A
• Device Lot Number: XG17
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/15/2019
• Initial Date FDA Received: 11/01/2019
• Supplement Dates Manufacturer Received: 11/14/2019
• Supplement Dates FDA Received: 11/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1