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

Model Number	HEMCSM10
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the hemcsm10 mean arterial pressure was anywhere from 20 to 40 points difference with the largest discrepancy when the patient was hypertensive.When the patient was hypotensive the blood pressure from the acumen cuff was with 8 mmhg pulse pressure.During this time the noninvasive blood pressure was unable to calculate a blood pressure.The cuff was sized correctly and placed correctly.The evhrs was leveled and zeroed and at the phlebostatic axis.There were no error messages displayed.The hemosphere was giving a blood pressure 140 over 80 with a mean of 90 whereas the noninvasive blood pressure cuff was giving 200 over 120.When the patient was hypotensive the blood pressure was 46 over 38 on the hemosphere.The rep replaced the csm module with another module and the blood pressures correlated.There was no patient injury.This was during use.There was no inappropriate patient treatment administered.Patient demographics were unavailable.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.The device evaluation is anticipated.However the complaint cannot be confirmed without the completion of a product evaluation.A supplemental report will be forthcoming when the investigation is completed.
Additional Manufacturer Narrative
A supplemental mdr is being submitted as a product evaluation was initiated for any manufacturing related processes which could be correlated to the complaint.One (b)(6) was received for product evaluation.The (b)(6) was connected to a known working hem1 hot mock-up.It was able to obtain normal blood pressure readings and waveform without errors.It was monitored for over an hour without any deviations in the readings.No damage was found.The device history review was completed and all inspections passed with no nonconformances.

• Brand Name: HEMCSM10
• Common Device Name: 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: katheryn cespedes ; one edwards way; irvine, CA 92614
• MDR Report Key: 19043636
• Report Number: 2015691-2024-02574
• Device Sequence Number: 7354628
• Product Code: DQK
• UDI-Device Identifier: 00690103202762
• UDI-Public: (01)00690103202762(11)210612
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K203687
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/12/2026
• Device Model Number: HEMCSM10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2024
• Supplement Date Received by Manufacturer: 05/01/2024
• Initial Report FDA Received Date: 04/04/2024
• Supplement Report FDA Received Date: 05/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/12/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown