MAUDE Adverse Event Report: EDWARDS LIFESCIENCES HEMCSM10; HEMOSPHERE CLEARSIGHT MODULE

Model Number HEMCSM10

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 04/25/2023

Event Type  malfunction  

Manufacturer Narrative

The product will not been returned for evaluation.However, logs were submitted.Once the product evaluation has been completed, a supplemental report will be submitted.The device history record review was completed and all inspections passed with no non-comformances.

Event Description

It was reported that the hemcsm10 systolic blood pressure was running low after being upgraded to the clear sight diastolic fix.The diastolic blood pressure and mean arterial pressure values were in agreement.There were no error messages.They ensured set up and zero were appropriate in comparison to the a line.There was no patient injury.No inappropriate patient treatment was administered and patient demographics were unavailable.

Manufacturer Narrative

A supplemental mdr is being submitted due to product evaluation findings.Sections g6, h2, h6: type of investigation, investigation findings, investigation conclusions and have been updated.The hemcsm10 was not returned for evaluation.However, logs were provided.No clinical data logs were provided for the investigation.The root cause remains unknown as no product was returned for evaluation and the logs provided were not sufficient for the investigation.H3 other text : device not returned but logs were sent and evaluated.

• Brand Name: HEMCSM10
• Type of Device: HEMOSPHERE CLEARSIGHT MODULE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: jessica atallah ; one edwards way; irvine, CA 92614 ; 9492500294
• MDR Report Key: 16934521
• MDR Text Key: 315278346
• Report Number: 2015691-2023-13001
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 00690103202762
• UDI-Public: (01)00690103202762(11)210715
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201446
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/25/2023

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 Model Number: HEMCSM10
• Device Catalogue Number: HEMCSM10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/25/2023
• Initial Date FDA Received: 05/15/2023
• Supplement Dates Manufacturer Received: 07/17/2023
• Supplement Dates FDA Received: 07/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2021
• 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