MAUDE Adverse Event Report: EDWARDS LIFESCIENCES OXIMETRY CABLE; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number HEMOXSC100

Device Problems Display or Visual Feedback Problem (1184); No Device Output (1435); Failure to Read Input Signal (1581)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 06/19/2018

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 and device history record results when available.Mdr # for associated monitor- 2015691-2018-02757.

Event Description

It was reported during use, this oximetry cable and hemosphere monitor stopped showing cardiac output (co) and cardiac index (ci).The next day, the monitor froze on svo2 measurements with no new values recorded.The clinician attempted to restart continuous cardiac output (cco), which was successful and accurate after rebooting the system.They were unable to perform the oximetry calibration.The monitor was exchanged for a vigilance ii, which worked appropriately with the same swan ganz catheter.There was no report of any patient injury or compromise, and no treatment was given to the patient due to this event.Patient demographics were unable to be obtained.

Manufacturer Narrative

The device history record was reviewed with no related non-conformances found.

Manufacturer Narrative

Examination of the returned oximetry cable confirmed that logs showed that measurements stopped and there was an error message of ¿oximetry temperature¿, while being connected to a data bridge interface test tool at the local service provider.An engineering evaluation has been initiated to assess for any manufacturing-related processes which could be correlated to the complaint.With any hemodynamic monitoring, physiologic parameters can change quickly and dramatically.Svo2 is one indicator of multiple hemodynamic parameters that are used to base clinical treatment decisions.Clinicians are trained to evaluate the entire clinical presentation of the patient in order to make such decisions.In addition, these devices are used by highly trained clinicians experienced in assessing and mitigating any hazards that arise.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 a part of the monthly review.Please see medwatch #2015691-2018-02757 for the hem1 monitor involved in this event and medwatch #2015691-2018-03661 for the swan ganz module involved in this event.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

• Brand Name: OXIMETRY CABLE
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 7684084
• MDR Text Key: 114545857
• Report Number: 2015691-2018-02796
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• PMA/PMN Number: K163381
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/20/2018

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: 08/16/2022
• Device Model Number: HEMOXSC100
• Device Catalogue Number: HEMOXSC100
• Device Lot Number: 13700399
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2018
• Initial Date Manufacturer Received: 06/20/2018
• Initial Date FDA Received: 07/12/2018
• Supplement Dates Manufacturer Received: 07/24/2018; 08/20/2018; 07/23/2020
• Supplement Dates FDA Received: 08/13/2018; 09/04/2018; 12/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1