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

Model Number 52511-14

Device Problem Output Problem (3005)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Initial mfg.Lot build reviews: a review of the mfg.Lot build database for the two reported lot# recorded lot# 3139123 (mfg.11/2015) showed (b)(4) units and lot# 3077504 (mfg.07/2015) showed (b)(4) units were all mfg., tested, inspected and released.There were no exception documents generated during the lot builds.Qe investigation is in progress.

Event Description

Complaint received reporting intermittent svo2 reading issues with use of 52511-14 8f triox svo2/cco pa catheters.Information received reports there were four events (post op) where svo2 reading failures occurred and were described as follows ".Pre-insertion calibration would not complete even with multiple op mods.Once floated, catheter would not read sv02.Unable to see light on q2+.Op mod had light coming from tip.".Attending medical staff/clinicians are having to draw manual gasses every four hours for up to 2 days.(affecting).Timely administration of medical treatments.There were no reported patient injuries and or adverse patient outcomes.

• Brand Name: 8F TRIOX SVO2/CCO PA CATHETERS
• Type of Device: 8F TRIOX¿ SVO2/CCO PA CATHETERS
• 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: terry scesny ; 4455 atherton drive; salt lake city, UT 84123 ; 8012641400
• MDR Report Key: 5591399
• MDR Text Key: 43198902
• Report Number: 2025816-2016-00028
• Device Sequence Number: 1
• Product Code: DQE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K06299
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Medical Technologist
• Type of Report: Initial
• Report Date: 02/24/2016

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: Health Professional
• Device Model Number: 52511-14
• Device Catalogue Number: 52511-14
• Device Lot Number: 3139123; 3077504
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/25/2016
• Initial Date FDA Received: 04/20/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1