MAUDE Adverse Event Report: ICU MEDICAL, INC. TRIOX¿ SVO2 PA CATHETER P7110-EP8-H, 8F, 110CM, EXTRA PORT, HEPARIN COATED, LF; CATHETER, OXIMETER, FIBER-OPTIC

Catalog Number	50328-08
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	03/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It is unknown if the device is available for evaluation.The device has been requested to be returned, however, it has not been received.Without the returned device, a probable cause is unable to be determined.D4: only di provided as lot number is unknown.
Event or Problem Description
The event occurred on an unspecified date in march of 2024 and involved a triox¿ svo2 pa catheter p7110-ep8-h, 8f, 110cm, extra port, heparin coated, lf (swan-ganz).The device was placed in the cath lab and 2 of the 3-way stopcocks failed.One was on the infusion port and the other was on the pulmonary artery (pa) line which caused blood to back up.Both leaked from a crack/hole on the side of the "t".The original intended procedure was pulmonary artery catheter monitoring.This is not a single-use device that was reprocessed and reused on a patient.Approximate age of device: 1 day.There was unknown patient involvement and unknown adverse event.
Additional Manufacturer Narrative
The customer provided a lot #398374 which is unidentifiable.The reported complaint could not be confirmed.No product samples, pictures, or videos were received for investigation.Therefore, a comprehensive failure investigation cannot be performed and a cause cannot be determined.A manufacturing record review could not be completed as the lot number was not provided by the customer.

• Brand Name: TRIOX¿ SVO2 PA CATHETER P7110-EP8-H, 8F, 110CM, EXTRA PORT, HEPARIN COATED, LF
• Common Device Name: CATHETER, OXIMETER, FIBER-OPTIC
• Manufacturer (Section D): ICU MEDICAL, INC.; 4455 s. atherton drive; salt lake city UT 84123
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 20523025
• Report Number: 1713468-2024-00008
• Device Sequence Number: 9171049
• Product Code: DQE
• UDI-Device Identifier: 00840619059842
• UDI-Public: 00840619059842
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K091268
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2024

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 Catalogue Number: 50328-08
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2024
• Supplement Date Received by Manufacturer: 11/05/2024
• Initial Report FDA Received Date: 10/24/2024
• Supplement Report FDA Received Date: 12/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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