MAUDE Adverse Event Report: EDWARDS LIFESCIENCES COMPUTER, DIAGNOSTIC, PROGRAMMABLE; HEMOSPHERE PRESSURE-OUT CABLE

Model Number HEMDPT1000

Device Problem Incorrect Measurement (1383)

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

Event Date 09/14/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

As reported, during use in patient of this hemosphere pressure out cable with a swan ganz catheter and an hemosphere monitor, the cvp (central venous pressure) values displayed on the bedside monitor were not correct.The cvp signal which was displaying blue on the bedside monitor was showing the arterial pressure numbers map 75mmhg.Correct values were displayed on the hemosphere monitor.There was no error message displayed.The pressure-out cable was changed for another one and the issue was solved.Patient was not treated according the incorrect values shown.Follow-up support on the use of the device was provided to the customer by edwards sales representative, and further education is scheduled.There was no allegation of patient injury.The product is expected to be returned for analysis; however, it has not yet been received.Patient demographics requested but not available.

Manufacturer Narrative

One hemosphere pressure cable was received for examination.The report was confirmed.Cable was tested with a digital multi-meter and it was found that the connections from j1, j2, and j3 read as open to j4.There was no external damage observed to the cable.The device service history record review was completed, and all manufacturing inspections passed with no non-conformances.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: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Type of Device: HEMOSPHERE PRESSURE-OUT CABLE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 12567139
• MDR Text Key: 274448710
• Report Number: 2015691-2021-05495
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183413
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/21/2021

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: 02/22/2024
• Device Model Number: HEMDPT1000
• Device Catalogue Number: HEMDPT1000
• Device Lot Number: 024380
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/15/2021
• Initial Date FDA Received: 10/04/2021
• Supplement Dates Manufacturer Received: 12/03/2021
• Supplement Dates FDA Received: 12/21/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2019
• 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