MAUDE Adverse Event Report: EDWARDS LIFESCIENCES COMPUTER, DIAGNOSTIC, PROGRAMMABLE; HEMOSPHERE CLEAR SIGHT MODULE

Model Number HEMCSM10

Device Problem Incorrect Measurement (1383)

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

Event Date 07/15/2021

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, when starting monitoring with this clear sight module, the pump made an unusual noise and error messages, error module hemosphere clearsight and pump unit defect, were displayed for five minutes.Blood pressure values displayed by the clear sight module were 124 mmhg/55 mmhg/76 mmhg, which were considered incorrect as per patient medical condition.There was no specific message displayed for the values issue.The blood pressure was also being measured by an artery line placed on the same arm and the values displayed were correct (163mmhg/53 mmhg (84 mmhg)).The sqi indicator was 4/4.Troubleshooting was done by removing and replacing the clear sight module; however, it was not sure if this resolved the error from the screen.Once the error messages disappeared, the pump unit worked again; however, the values still did not match.Patient was treated correctly based on the values provided by the arterial line.There was no allegation of patient injury.The product is expected to be returned for analysis; however, it has not yet been received.

Manufacturer Narrative

Correction for model updated to hemcsm10 hemosphere clear sight module.Per further follow on event description, it was specified that both when there was a message displayed or when there was no message displayed, values were not matching.One hemcsm10 hemosphere clearsight module and one hem1 hemosphere monitor were received for a full examination.From visual inspection, no physical defects were identified on this hemosphere monitor clearsight module hemcsm10.The returned hem1 monitor was turned on and the returned hemosphere clearsight module hemcsm10 was connected.Using workshop kgu pc2k and hrs it was tried to simulate pressure values, however in a few seconds an error message "fault: clear sight module" was displayed.The returned hemosphere clearsight module hemcsm10 was plugged into workshop kgu hem1 monitor and the same behavior was observed.Returned hem1 hemosphere monitor was tested with workshop kgu hemcsm10 and no issue was observed, it passed all the tests.The problem was isolated to the returned hemcsm10 hemosphere clearsight module.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.

Manufacturer Narrative

An additional examination of the returned hemosphere clearsight module was further completed.The report was not confirmed since no failure was found.The hemosphere clearsight module hemcsm10 was connected to workshop known working hem10 system 3 times.Each time the hemcsm10 caused no errors and was able to obtain normal blood pressure readings and waveform.No abnormal noises were heard, and no damage was found.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 CLEAR SIGHT MODULE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 12279316
• MDR Text Key: 265147932
• Report Number: 2015691-2021-04492
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• PMA/PMN Number: K211465
• 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: 10/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HEMCSM10
• Device Catalogue Number: HEM1
• Device Lot Number: 13825160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 60 YR