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

Model Number 3CX*RX25RW

Device Problem Material Twisted/Bent (2981)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/19/2020

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 prior to cardiopulmonary bypass, during prime, there was a bent port on the manifold.No patient involvement.The product was 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 january 12, 2021.Upon further investigation of the reported event, the following information is new and/or changed: d4 (additional device information - added expiration date) d8 (device serviced by a third party) d10 (device availability - added date returned to 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 483, 2645, 4582, 10, 11, 3331, 3259, 4307) component code: 483 - manifold health effect - impact code: 2645 - no patient involvement health effect - clinical code: 4582 - no clinical signs, symptoms or conditions 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: 4307 - cause traced to component failure the affected sample was inspected upon receipt confirming damage to the manifold.A representative retention sample was inspected for damage.No damage was observed on the unit, specifically on the manifold.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
• MDR Report Key: 11153653
• MDR Text Key: 247557804
• Report Number: 1124841-2021-00002
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 00699753450110
• UDI-Public: (01)00699753450110
• Combination Product (y/n): N
• PMA/PMN Number: K153213
• 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: 02/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: 3CX*RX25RW
• Device Catalogue Number: N/A
• Device Lot Number: YD02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1