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

Catalog Number	52510-14
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	11/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to return to the manufacturer for investigation, however, it has not been received.
Event or Problem Description
The event involved blood loss that occurred during use of a triox¿ svo2/cco pa catheter.It was reported that the triox cco/svo2 catheter was no longer providing a continuous cardiac output (cco) value when the patient came off bypass.Blood was discovered dripping out of the thermistor hub when the thermistor cable was removed.The event occurred during use on patient for 3 hours.The issue was noticed when there wasn't a cco value on the monitor.No adverse event occurred.
Additional Manufacturer Narrative
H10: the device was returned to the manufacturer on december 9, 2019.Received one (1) used list# 52510-14, triox¿ svo2/cco pa catheter, 8f, 110cm, j-tip, heparin coated; lot # 4135481 for investigation.The reported complaint of unable to obtain continuous cardiac output (cco) value and blood leak in the hub was confirmed.The electrical characteristics of the thermistor was measured and found to be inconsistent.When the thermistor hub was cut open and hydrostatically leak tested, a leak was observed inside the hub.The thermocoil was uncoiled and the lumen was cut open to determine the cause of the leak.A nick was observed between the distal thermal positioning port (dtpp) lumen and the thermistor lumen.The cause for no cco value is due to the fluid ingress inside the thermistor hub.The probable cause for the nicks in the inner lumen could not be determined.A device history review (dhr) lot# 4135481 and relevant commodities were reviewed, and no non-conformances were found that would have contributed to the reported complaint.

• Brand Name: TRIOX¿ SVO2/CCO PA CATHETER, 8F, 110CM, J-TIP, HEPARIN COATED
• Common Device Name: CATHETER, OXIMETER, FIBER-OPTIC
• Manufacturer (Section D): ICU MEDICAL, INC.; 4455 s. atherton drive; salt lake city UT 84123
• MDR Report Key: 9443391
• Report Number: 1713468-2019-00026
• Device Sequence Number: 2055673
• Product Code: DQE
• UDI-Device Identifier: 00840619059828
• UDI-Public: (01)00840619059828(17)210201(10)4135481
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K091268
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2019

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: 02/01/2021
• Device Catalogue Number: 52510-14
• Device Lot Number: 4135481
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/25/2019
• Supplement Date Received by Manufacturer: 01/17/2020
• Initial Report FDA Received Date: 12/10/2019
• Supplement Report FDA Received Date: 01/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1