MAUDE Adverse Event Report: EDWARDS LIFESCIENCES VOLUMEVIEW THERMODILUTION CABLE; SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE

Model Number EVVVTC1

Device Problem Incorrect Measurement (1383)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/11/2021

Event Type  malfunction  

Manufacturer Narrative

Ev1000 volumeview cable was returned and the evaluation process is ongoing.The device service history record review was completed, and all manufacturing inspections passed with no non-conformances.Results of product evaluation will be provided through a supplemental report.

Event Description

As reported, during use in patient of this ev1000 volumeview cable, the temperature value measured was lower than the one displayed on the patient monitor, which lead to failure to calculate the cardiac output normally.It is unknown what temperature they were comparing against.The cable was replaced for a new one and the issue was solved.Unfortunately, no further information was available.There was no allegation of patient injury.Patient demographics requested but not available.

Manufacturer Narrative

The cable was received for examination.It was tested using a multimeter and found defective.Internal components seems disconnected.An engineering investigation has been initiated for further investigation and to consider any potential factors that may have contributed to this complaint.Results will be provided through a supplemental report.

Manufacturer Narrative

An additional evaluation of the ev1000 volumeview cable was completed.The report was not confirmed since no failure was found on the returned cable.The cable passed three times the cirris continuity cable test, bending and moving the cable between each test.There was no visible physical damage observed.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.

• Brand Name: VOLUMEVIEW THERMODILUTION CABLE
• Type of Device: SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 11782058
• MDR Text Key: 251712060
• Report Number: 2015691-2021-02822
• Device Sequence Number: 1
• Product Code: DXN
• Combination Product (y/n): N
• PMA/PMN Number: K203131
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 07/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2021
• Device Model Number: EVVVTC1
• Device Catalogue Number: EVVVTC1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1