MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC HEMOSPHERE; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number HEMCARDIAQ

Device Problems Unable to Obtain Readings (1516); Defective Device (2588)

Patient Problems Failure of Implant (1924); Needle Stick/Puncture (2462)

Event Date 02/17/2023

Event Type  malfunction  

Event Description

We have seen patients who have perfect pa waveforms, placements verified by cxr and able to draw mixed venous with the message of ¿fault co- check thermal filament position¿ to the point of catheters being taken out of patients since data is not available.This is in a cticu.Staff are very familiar with pacs, cables, hemospheres have been changed, again placement verified and all to no avail.At least 3+ patients who we could not get data on.Started mid-december and continues through mid-march.Some patients have had defective pa catheter replaced.

• Brand Name: HEMOSPHERE
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• MDR Report Key: 16610131
• MDR Text Key: 311936137
• Report Number: 16610131
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: HEMCARDIAQ
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/15/2023
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 03/24/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1