MAUDE Adverse Event Report: ICU MEDICAL, INC. TRIOX¿ SVO2/CCO PA CATHETER, 8F, 110CM, J-TIP, LF; CATHETER, OXIMETER, FIBER-OPTIC

Catalog Number	52516-15
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a triox¿ svo2/cco pa catheter, 8f, 110cm, j-tip, lf where it was reported that a triox svo2/cco pa catheter is unable to read accurate cardiac output on cogent cco monitor or manual thermodilution which could be a thermistor issue.The event occurred during continuous cardiac output monitoring.Thus, there was patient involvement, no human harm and there was delay in therapy reported.This report captures 2 occurrences.
Additional Manufacturer Narrative
The device has been received for evaluation.Investigation is pending.
Additional Manufacturer Narrative
Received: one (1) used list# 52516-15, triox¿ svo2/cco pa catheter, 8f, 110cm, j-tip, lf; lot# 14333507.One (1) used list# 52516-15, triox¿ svo2/cco pa catheter, 8f, 110cm, j-tip, lf; lot# 14333507 --> one (1) used list# unknown, clave; lot# unknown visual: the reported samples of two (2) used list# 52516-15, triox¿ svo2/cco pa catheters were received.No visual anomalies were observed.The balloon was tested and performed as expected on both the samples.The thermistor cable was able to be connected to the reusable cable.Functional: per the product specification pss.X.Opticath section 8, the thermistors are electrically tested.The catheter was connected to a q2 plus monitor (a-3g-181) and the catheter was placed in a 37°c water bath (t-1g-051).When connected to the q2 plus monitor (a-3g-181) both the catheters were able to obtain a cco value.The product had performed per the specifications.The reported complaint of no continuous cardiac output (cco) value was not confirmed on the returned set.No visual anomalies were observed.The balloon was tested and performed as expected on both samples.The electrical characteristics of the thermistor were measured and found to be within the product specifications on both samples.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: TRIOX¿ SVO2/CCO PA CATHETER, 8F, 110CM, J-TIP, 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: 22998248
• Report Number: 1713468-2025-00013
• Device Sequence Number: 9090458
• Product Code: DQE
• UDI-Device Identifier: 00840619060305
• UDI-Public: (01)00840619060305(17)260301(10)14333507
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2025

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: 03/01/2026
• Device Catalogue Number: 52516-15
• Device Lot Number: 14333507
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2025
• Supplement Date Received by Manufacturer: 10/02/2025
• Initial Report FDA Received Date: 09/08/2025
• Supplement Report FDA Received Date: 10/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/11/2025
• 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