MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION CDI SHUNT SENSOR; MONITOR, BLOOD-GAS, ON-LINE, CARDIOPULMONARY BYPASS

Model Number	CDI510H
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during prime, they noticed a leaking cdi shunt sensor.It was tried several times to disconnect and reconnect, but it persisted leaking.No patient involvement.Product was changed out.Procedure completed successfully.
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.
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.For this reason, terumo references evaluation conclusion code 11.H3: evaluation is in progress, but not yet concluded.
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: g3 (date received by 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).H6 (identification of evaluation codes 10, 3331, 4210, 19).The returned sample was visually inspected upon receipt, during which it was noted that the large bore adapter cap was not fully tightened and was leak tested, connecting with a calibrated manometer, submerged into a water bath, and pressurized up to 1030 mmhg and a leak was noted immediately.The large bore adapter blue cap was then loosened and re-tightened by hand and leak tested a second time and no leaks were noted.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Brand Name: CDI SHUNT SENSOR
• Common Device Name: MONITOR, BLOOD-GAS, ON-LINE, CARDIOPULMONARY BYPASS
• 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: 20217893
• Report Number: 1124841-2024-00100
• Device Sequence Number: 20664842
• Product Code: DRY
• UDI-Device Identifier: 00699753160767
• UDI-Public: (01)00699753160767(17)250430(10)4F28F
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K133658
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/08/2024

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: 04/30/2025
• Device Model Number: CDI510H
• Device Catalogue Number: N/A
• Device Lot Number: 4F28F
• 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: 08/22/2024
• Supplement Date Received by Manufacturer: 09/19/2024; 10/16/2024
• Initial Report FDA Received Date: 09/13/2024
• Supplement Report FDA Received Date: 10/11/2024; 11/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/20/2024
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown