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

Model Number	3CX*RX25RE
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/24/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
The subsidiary reported to terumo cardiovascular that during quality inspection, they noted the oxygenator had no label.No patient involvement.
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 march 23, 2020.Upon further investigation of the reported event, the following information is new and/or changed: d4 (additional device information - added expiration date); g4 (date received by manufacturer); g7 (indication that this is a follow-up report); h2 (follow-up due to additional information); h4 (device manufacture date); h6 (identification of evaluation codes 11, 3331, 4114, 150, 25).Method code #1:11 - testing of device from same lot/batch retained by manufacturer.Method code #2: 3331 - analysis of production records.Method code #3: 4114 - device not returned.Results code: 150 - labeling and instructions for use/maintenance.Conclusions code: 4315 - cause not established.The sample was not returned for investigation, however the photos provided with complaint confirmed the missing box label.The retention sample was inspected and was found to be labeled properly.Review of device history were reviewed indicating no abnormalities related to the issue.Capiox labeling is 100% inspected and label reconciliation is completed ensure each part meets tcvs specifications.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Brand Name: CAPIOX RX25 OXYGENATOR EAST
• Common Device Name: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• MDR Report Key: 9869552
• Report Number: 1124841-2020-00073
• Device Sequence Number: 13602143
• Product Code: DTZ
• UDI-Device Identifier: 00699753450103
• UDI-Public: (01)00699753450103
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2020

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: Other
• Device Expiration Date: 11/30/2022
• Device Model Number: 3CX*RX25RE
• Device Catalogue Number: N/A
• Device Lot Number: XP09
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/02/2020
• Supplement Date Received by Manufacturer: 04/29/2020
• Initial Report FDA Received Date: 03/23/2020
• Supplement Report FDA Received Date: 05/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1