MAUDE Adverse Event Report: ICU MEDICAL INC. TRIOX PA CATHETER

Model Number 52516-15

Device Problem Output Problem (3005)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/15/2017

Event Type  malfunction  

Manufacturer Narrative

Lot review: a review of suspect lot# 3379096 showed that (b)(4) units were manufactured, tested, inspected and released in january 2017 citing no exception documents.

Event Description

Complaint received reporting reading issues with use of 52516-15, 8 f triox¿ svo2/cco pa catheter.The initial information received reports ".The doctor did not trust the (pa waveform & ci readings) numbers and called for a bedside echocardiogram that revealed a well functioning heart.".There were no reported adverse consequences.

• Brand Name: TRIOX PA CATHETER
• Type of Device: TRIOX PA CATHETER
• 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: 6461687
• MDR Text Key: 72110844
• Report Number: 2025816-2017-00091
• Device Sequence Number: 1
• Product Code: DQE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061450
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/05/2017

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?: Yes
• Device Operator: Physician
• Device Expiration Date: 01/01/2018
• Device Model Number: 52516-15
• Device Catalogue Number: 52516-15
• Device Lot Number: 3379096
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/05/2017
• Initial Date FDA Received: 04/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1