MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION CARDIOVASCULAR PROCEDURE KIT; N/A

Model Number	74283
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2024
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.For this reason, terumo references evaluation conclusion code 11.
Event or Problem Description
The user facility reported to terumo cardiovascular that during cardiopulmonary bypass, the oxygenator was not performing adequately and they had to cut in another.No known consequence or impact to the patient.There was a 5 - 10-minute delay in cutting in additional oxygenator.The product was not 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 july 03, 2024.Upon further investigation of the reported event, the following information is new and/or changed: d1 (corrected brand name).D2a (corrected common device name).D4 (updated model number & lot number, added expiration date & primary unique device identification number).D9 (device available for evaluation).H2 (follow-up due to correction and additional information).H3 (evaluation is in progress, but not yet concluded).H4 (device manufacture date).Another follow-up will be submitted upon completion of the investigation and/or submission of new information, thus tcvs references conclusions code 11.
Additional Manufacturer Narrative
This follow-up report is submitted to fda in accord with applicable regulations.Upon further investigation of the reported event, the following information is new and/or changed: h6 (identification of evaluation codes 10, 3331, 3221, 4315).The returned sample was visually inspected upon receipt with no anomaly such as breakage.It was then rinsed and dried, and the amount of oxygen transfer and carbon dioxide gas removal were measured according to the product inspection procedure.The gas transfer performance of actual sample after rinsing met the factory's specifications, and no anomaly was found in the manufacturing records.Since no anomaly was found in the actual sample, the cause of the occurrence could not be clarified.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Brand Name: CARDIOVASCULAR PROCEDURE KIT
• Common Device Name: N/A
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• Manufacturer (Section G): SAME
• Manufacturer Contact: douglas patton ; 125 blue ball road; elkton, MD 21921 ; 7346634145
• MDR Report Key: 19668666
• Report Number: 1124841-2024-00078
• Device Sequence Number: 6836275
• Product Code: DTZ
• UDI-Device Identifier: 00699753487703
• UDI-Public: (01)00699753487703(17)260131(10)4C19
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/17/2024

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: 01/31/2026
• Device Model Number: 74283
• Device Catalogue Number: N/A
• Device Lot Number: 4C19
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2024
• Supplement Date Received by Manufacturer: 07/19/2024; 09/26/2024
• Initial Report FDA Received Date: 07/03/2024
• Supplement Report FDA Received Date: 08/12/2024; 10/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/22/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown