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

Model Number HEM1

Device Problem Incorrect Measurement (1383)

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

Event Date 07/13/2023

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 an investigation will be completed to consider any potential factors that may have contributed to this complaint and a supplemental report will be sent with the investigation results.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.H3 other text : the product is expected to be returned for analysis; however, it has not yet been received.

Event Description

As reported, during use in patient with this hemosphere monitor, within a few seconds the svo2 signal changed around 10%.There was no allegation of patient injury.The device was available for evaluation.

Manufacturer Narrative

It was further informed that the device was not available for evaluation.Without return of the product, edwards is unable to perform a complete investigation of the reported event.It is not possible to determine what factors may have contributed to it, and therefore no actions could be planned.The manufacturing records were reviewed and there is no indication of a related nonconformance.All process parameters were met and inspections passed successfully.Based on further engineering investigation, the issue occurred as a result of the end user failing to follow the ifu instructions with regards to svo2 drifting.The ifu was reviewed and found adequate.H3 other text : device not available for evaluation.

Manufacturer Narrative

Finally, the hemosphere monitor was received by the original manufacturer for a full examination.As received, the hem1 was connected to ac together with a known good unit (kgu) oximetry cable and a kgu swan-ganz catheter.In-vitro calibration was performed and after that stable values were obtained.However, when the cable was held with the hand for a few minutes, the values started to fluctuate between 78-81 per cent.Values did not go higher or lower than that range.When the cable was left back on the table without touching it, the values become stable again.The report of "svo2 signal changed" could be confirmed; however, the issue could not be fully reproduced as the variation in the workshop was not as high as reported.It was found the led cover and diffuser were missing from the bezel alarm.As a precaution the unit was reworked with a new revision backplane.After this, the slight variation observed in the workshop disappeared.The front bezel alarm was also replaced.The unit passed all tests according to internal procedures: electrical safety test, functional test, run-in and final verification.Based on further engineering investigation, and based on the product evaluation findings, including testing potential misuse scenarios, that implied that the reported event was only occurring while holding the cable with the hand, it could be concluded that the issue occurred as a result of use error where the user failed to follow ifu instructions for dealing with svo2 drifting.The ifu instructs to "do not wrap the main body of the oxsc cable in fabric", "do not place oxsc cable directly on the patient skin." and to "secure oxsc cable to prevent unnecessary movement".Based on the investigation the updated backplane replacement mitigates the issue and makes the system better to be able to handle the scenario of the customer not following the ifu.Pra was initiated for this issue earlier.Additionally, the missing alarm cover is considered as physical damage caused by the handling of the device by the end user.

• Brand Name: HEMOSPHERE ADVANCED MONITOR
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 17470746
• MDR Text Key: 320732223
• Report Number: 2015691-2023-15079
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K223865
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/18/2023
• Device Model Number: HEM1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/18/2018
• 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