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 three reported lot# recorded lot# 3124651 (mfg.10/2015) showed (b)(4) units; lot# 3086248 (mfg.07/2015) also showed (b)(4) units and lot# 3129155 (mfg.10/2015) 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, multiple lot#.The initial information received reports over the past two weeks unspecified number of occurrences (pre and post op) where svo2 reading failures occurred.The initial information received reports ".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.".One event was described as follows ".After placement of catheter attempts to obtain sv02 readings were unsuccessful, the catheter was removed and replaced with a second catheter which also failed to provide svo2 readings.Attending medical staff/clinicians are having to draw manual gasses every four hours for up to 2 days which is causing "critical delays in assessments.Timely administration of medical treatments." there were no reported patient injuries and or adverse patient outcomes.Reported lot# 3124651 (mfg.10/2015) (b)(4) units; 3086248 (mfg.07/2015) (b)(4) units; 3129155 (mfg.10/2015) (b)(4) units.

• 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: 5591055
• MDR Text Key: 43171963
• Report Number: 2025816-2016-00024
• 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: 02/17/2016

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: 3124651;3086248;3129155
• 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: Initial
• Patient Sequence Number: 1