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

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	11/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been requested for return but has not yet arrived.When it has arrived and the product evaluation has been completed, the evaluation findings will be sent in a supplemental report.The device history record review has been completed and all manufacturing inspections passed with no non conformances.
Event or Problem Description
It was reported that there was a malfunction with the clearsight module, during patient use.There were inaccurate bp values that displayed.The clearsight bp was 160/30 approximately, the nibp was 200/100 approximately.There were no error messages.The issue was isolated to the cs module.There was no arterial line.There was no inappropriate treatment administered.Patient demographics unknown.There was no patient harm or injury.
Additional Manufacturer Narrative
The clearsight module was returned and evaluated.The suspect csm was connected to a known good working hemosphere instrument for testing.There were no error messages that displayed.There were normal blood pressure readings and a normal waveform that were able to be acquired.The components were left to monitor for 1.5 hours.The readings remained stable.There was no issue found.A visual inspection found no damage to the device.The reported issue was not confirmed.There will be no further action taken at this time.
Additional Manufacturer Narrative
Udi related data quality updates only.The following are additional product codes for this device: dqe, catheter, oximeter, fiber-optic; qaq, adjunctive predictive cardiovascular indicator; mud, oximeter, tissue saturation; dsb, plethysmograph, impedance; qms, adjunctive open loop fluid therapy recommender; fll, thermometer, electronic, clinical; dxn, system, measurement, blood-pressure, non-invasive.The following is corrected data, as the original identification information sent did not match the data submitted to the global unique device identification database (gudid) d1 brand name: hemosphere.D2a common device name: computer, diagnostic, programmable.

• Brand Name: HEMOSPHERE
• Common Device Name: 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: jonathan diaz ; one edwards way; irvine, CA 92614
• MDR Report Key: 18222567
• Report Number: 2015691-2023-17757
• Device Sequence Number: 5672020
• Product Code: DQK
• UDI-Device Identifier: 00690103202762
• UDI-Public: (01)00690103202762(11)220608
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K201446
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/18/2024

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 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: 11/14/2023
• Supplement Date Received by Manufacturer: 12/12/2023; 07/09/2024
• Initial Report FDA Received Date: 11/28/2023
• Supplement Report FDA Received Date: 12/20/2023; 07/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/09/2022
• 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