MAUDE Adverse Event Report: ICU MEDICAL INC. TRIOX SVO2 / CCO PA CATHETER

Model Number 52510-15

Device Problem Output Problem (3005)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/28/2017

Event Type  malfunction  

Manufacturer Narrative

Pending receipt of device.

Event Description

Complaint received reporting erroneous/no readings with use of one 52510-15 triox¿ sv02/cco pa 8f catheter.The initial information received reports ".Pa would transmit pressures but no cco or sv02.".The catheter was removed and replaced with no further issues encountered.There were no reported adverse patient consequences.

• Brand Name: TRIOX SVO2 / CCO PA CATHETER
• Type of Device: TRIOX SVO2 / CCO 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: terry scesny ; 4455 atherton dr.; salt lake city, UT 84123 ; 8012641400
• MDR Report Key: 6545010
• MDR Text Key: 74495009
• Report Number: 2025816-2017-00097
• Device Sequence Number: 1
• Product Code: DQE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091268
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/04/2017

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: Health Professional
• Device Model Number: 52510-15
• Device Catalogue Number: 52510-15
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/04/2017
• Initial Date FDA Received: 05/04/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1