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

Model Number	3CX*RX25RW
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during prime, they noticed leakage from manifold.No patient involvement.Product was changed out.Procedure was completed successfully.
Additional 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 november 16, 2020.Upon further investigation of the reported event, the following information is new and/or changed: h6 (identification of evaluation codes 517, 2199, 4582, 1354, 10, 11, 4210, 4315).Component code: 517 - stopcock.Health effect - impact code: 2199 - no health consequences or impact.Heatlh effect - clinical code: 4582 - no clinical signs, symptoms or conditions.Medical device problem code: 1354 - leak/splash.Type of investigation code #1: 10 - testing of actual/suspected device.Type of investigation code #2: 11 - testing of device from same lot/batch retained by manufacturer.Investigation findings: 4210 - leakage/seal.Investigation conclusions: 4315 - cause not established.The affected sample was inspected upon receipt, confirming one stopcock had leaked.A representative retention sample was inspected for damage.No damage was observed on the unit, specifically on the manifold.A sncr was issued to the supplier for this event to investigate and determine that there was no defect in the manufacturing of 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
• Common Device Name: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• MDR Report Key: 10848734
• Report Number: 1124841-2020-00264
• Device Sequence Number: 910180
• Product Code: DTZ
• UDI-Device Identifier: 00699753450110
• UDI-Public: (01)00699753450110
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K153213
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2021

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
• Operator of Device: 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: 11/10/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/28/2020
• Supplement Date Received by Manufacturer: 02/02/2021
• Initial Report FDA Received Date: 11/16/2020
• Supplement Report FDA Received Date: 02/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1