MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION CAPIOX RX25 OXYGENATOR WEST; BLOOD GAS OXYGENATOR

Model Number 3CX*RX25RW

Device Problem Break (1069)

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

Event Date 12/06/2021

Event Type  malfunction  

Event Description

The user facility reported to terumo cardiovascular that prior to cardiopulmonary, during setup, they noticed a broken connector coming off the oxygenator.No patient involvement; product was changed out; procedure was completed successfully.

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).

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 december 21, 2021.Upon further investigation of the reported event, the following information is new and/or changed: d4 (additional device information - added expiration date and lot number).G3 (date received by manufacturer).G6 (indication that this is a follow-up report).H2 (follow-up due to additional information).H4 (device manufacture date).H6 (identification of evaluation codes 3331, 4114, 11, 3259, 4307).Type of investigation: #1: 11 - testing of device from same lot/batch retained by manufacturer type of investigation #2: 3331 - analysis of production records.Type of investigation #3: 4114 - device not returned.Investigation findings: 3259 - improper physical structure.Investigation conclusions: 4307 - cause traced to component failure.The affected sample was not returned; however, a picture was provided that showed the arterial thermistor being broken off.A representative retention sample was reviewed and found to have no damage to the oxygenator, specifically in the area of the arterial thermistor.All capiox units are 100% visually inspected at several points in the production process.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Brand Name: CAPIOX RX25 OXYGENATOR WEST
• 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: jamie quinlan ; 125 blue ball road; elkton, MD 21921 ; 8002837866
• MDR Report Key: 13052754
• MDR Text Key: 290292120
• Report Number: 1124841-2021-00281
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 00699753450110
• UDI-Public: (01)00699753450110
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153213
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3CX*RX25RW
• Device Catalogue Number: N/A
• Device Lot Number: ZG14
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2021
• 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