MAUDE Adverse Event Report: EDWARDS LIFESCIENCES CO-SET INJECTATE PROBE CABLE; CO-SET CABLE

Model Number 93522

Device Problem Incorrect Measurement (1383)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/07/2017

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned for analysis; however, it has not been received yet.Upon return of the product for evaluation a supplemental report will be submitted with the evaluation findings.

Event Description

It was reported that when using the co-set cable the thermal temperature was not correlating with the cardiac output numbers.After performing ice water boluses, the temperature reading was room temperature range when it should have been reading a value correlating with the ice water bolus.This occurred during patient use.The co-set device and the catheter were ruled out as being a contributor to the issue.The patient demographic information is not available.There was no patient treatment administered.There was no patient compromise.

Manufacturer Narrative

The suspect co-set cable was not returned by the facility for product evaluation.Edwards is unable to confirm or negate the customers experience without the return of the suspect device.If the product is received a supplemental report will be submitted.The device service history record review could not be completed as the correct serial/lot number is unknown.The co-set cable is utilized to detect temperature readings of the injectate fluid that assists in the calculation of cardiac output.Clinicians are well versed in understanding the technique and temperature values that are expected to obtain a correct cardiac output thermodilution curve and cardiac output value.If the temperature reading or the thermodilution curve is incorrect, the clinician will start the troubleshooting process.In this instance the clinician recognized the incorrect temperature reading.There was no incorrect treatment or patient injury noted.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.No actions will be taken at this time.

• Brand Name: CO-SET INJECTATE PROBE CABLE
• Type of Device: CO-SET CABLE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: lynn selawski ; one edwards way; irvine, CA 92614 ; 9497564386
• MDR Report Key: 6747147
• MDR Text Key: 81197757
• Report Number: 2015691-2017-02239
• Device Sequence Number: 1
• Product Code: KRB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K811399
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 07/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 93522
• Device Catalogue Number: 93522
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/27/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: CO-SET DEVICE AND CATHETER