MAUDE Adverse Event Report: ICU MEDICAL INC. TRIOX SVO2/CCO PA CATHETER, 8F; TRIOX¿ SVO2/CCO PA CATHETER, 8F

Model Number 52516-15

Device Problem Output Problem (3005)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/01/2017

Event Type  malfunction  

Manufacturer Narrative

Lot review: a review of lot# 3333336 showed that (b)(4) units were manufactured, tested, inspected and released in november 2016 citing no exception documents.A review of lot# 3338041 showed that (b)(4) units were manufactured, tested, inspected and released in november 2016 citing no exception documents.

Event Description

Complaint received regarding two 52516-15, triox¿ svo2/cco pa catheter, 8f, 110 cm, j-tip; lot# 3333336 (mfd.11/2016), lot# 3338041 (mfd.11/2016) and lot# 3379096 (mfd.01/2017).Report states:.The laser would not transmit through the catheter; unable to reference light source; and lack of hemodynamic numbers on the display.The latter occurred in different or with different monitors and user.Delay in critical therapy and med/surg intervention required.No adverse patient consequences reported, no baseline changes.

Manufacturer Narrative

Lot review: a review of lot# 3333336 showed that (b)(4) units were manufactured, tested, inspected and released in november 2016 citing no exception documents.A review of lot# 3338041 showed that (b)(4) units were manufactured, tested, inspected and released in november 2016 citing no exception documents.Visual inspection: 3/17/2017 - received two used 52516-15, triox¿ svo2/cco pa catheter, 8f, 110 cm, j-tip; lot# 3379096.The balloons and fiber optics were all function for each catheter.One catheter had a touch contamination shield covering the catheter from the 10 to 80 cm marks.Functional testing: both units were visually inspected no defect was found with the fiber optic.Unit was pre insertion calibrated and no failures were observed.Both units were thruput tested and no defect was found with the catheter fiber optics.The unit functioned per specification.Final analysis summary: the reported complaint of would not transmit through the catheter could not be confirmed.The unit was observed to function per specification.The root cause of the failure could not be determined.Catheter is intended for continuous use up to 72 hours.Icu medical will continue to monitor and trend the reported compliant.

Event Description

Complaint received regarding two 52516-15, triox¿ svo2/cco pa catheter, 8f, 110 cm, j-tip; lot# 3333336 (mfd.11/2016), lot# 3338041 (mfd.11/2016) and lot# 3379096 (mfd.01/2017).Report states:.The laser would not transmit through the catheter; unable to reference light source; and lack of hemodynamic numbers on the display.The latter occurred in different or with different monitors and user.Delay in critical therapy and med/surg intervention required.No adverse patient consequences reported, no baseline changes.

• Brand Name: TRIOX SVO2/CCO PA CATHETER, 8F
• Type of Device: TRIOX¿ SVO2/CCO PA CATHETER, 8F
• Manufacturer (Section D): ICU MEDICAL INC.; 4455 atherton dr.; salt lake city UT 84123
• Manufacturer (Section G): ICU MEDICAL INC.; 4455 atherton dr.; salt lake city UT 84123
• Manufacturer Contact: bob gillispie ; 4455 atherton dr.; salt lake city, UT 84123
• MDR Report Key: 6423879
• MDR Text Key: 70630877
• Report Number: 2025816-2017-00076
• Device Sequence Number: 1
• Product Code: DQE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K0614501
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/06/2017

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?: No
• Device Operator: Other Health Care Professional
• Device Expiration Date: 10/01/2017
• Device Model Number: 52516-15
• Device Catalogue Number: 52516-15
• Device Lot Number: 3338041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/02/2017
• Initial Date FDA Received: 03/22/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/15/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1