MAUDE Adverse Event Report: ICU MEDICAL, INC. 8F OPTIQ SVO2 / CCO CATHETER

Model Number 52510-15

Device Problem Unable to Obtain Readings (1516)

Patient Problems No Consequences Or Impact To Patient (2199); Therapy/non-surgical treatment/delayed/prolonged (2520)

Event Date 04/30/2015

Event Type  malfunction  

Event Description

Complaint received reporting reading issues with use of one 52510-15, 8f optiq, svo2/cco catheter.The initial information received reported "thermal coil fault, switched cables and q2+.Catheter would not read cco/cci.Svo2 worked fine." it was reported that this issue did contribute a delay as attending clinicians were troubleshooting the devices, equipment and changeouts.The 52510-15 catheter device was removed and replaced with no further issues encountered.The catheter was successfully pre-tested during initial set-ups as well as pre-insertion tested, successfully placed and in use for approximately five hours into the procedure when the reading issues occurred.There were no reported patient injuries and or adverse consequences.Device return: one used 52510-15 catheter, unknown accessory tubing devices attached to the dtp, ra and pa lines.

Manufacturer Narrative

Device investigation in progress.

• Brand Name: 8F OPTIQ SVO2 / CCO CATHETER
• Type of Device: CATHETER
• Manufacturer (Section D): ICU MEDICAL, INC.; salt lake city UT
• Manufacturer Contact: terry scesny ; 4455 atherton dr.; salt lake city, UT 84123 ; 8012641400
• MDR Report Key: 4894488
• MDR Text Key: 6070091
• Report Number: 2025816-2015-00068
• Device Sequence Number: 1
• Product Code: DQE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/01/2015

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 Expiration Date: 12/01/2015
• Device Model Number: 52510-15
• Device Catalogue Number: 52510-15
• Device Lot Number: 2967562
• Other Device ID Number: PR# 30028
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/08/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: 05/08/2015
• Initial Date FDA Received: 07/02/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/01/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: Q2+ MONITOR; UNKNOWN CABLES