MAUDE Adverse Event Report: EDWARDS LIFESCIENCES IRVINE 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	01/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during use of the clearsight module it was providing low systolic and map pressure values compared to the arterial and brachial measurements on the patients bedside ge monitor.The values ranged anywhere from 10 to 70 points different in the systolic pressure.For the map the difference could be 10 up to 30 points difference.The patient had a brachial oscillometric cuff on.It was on the opposite arm then it was moved to the same side as the acumen cuff.There was no patient injury.
Additional Manufacturer Narrative
Additional fda product codes include: 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, olw- index-generating electroencephalograph software.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
One hemosphere clearsight module was returned for evaluation.The customer report of inaccurate values was not able to be confirmed.The clearsight module was connected to a known working hemosphere monitor hot mock-up system.The module caused no errors.It was also able to obtain normal blood pressure readings and waveform.During1 hour of monitoring, the blood pressure readings remained stable for the duration.No damage was found on the device.The device history record review was completed and the product passed without nonconformances.An engineering evaluation was initiated to assess for any manufacturing related processes which could be correlated to the complaint.As the device was returned and no defect was found, a product non-conformance or device failure associated to manufacturing or design could be confirmed.The instructions for use include the following cautions: inaccurate measurements can be caused by excessive variations in blood pressure, poor blood circulation in fingers, excessive patient movement, incorrect placement of finger cuff, or a bent cuff.

• Brand Name: HEMOSPHERE
• Common Device Name: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): EDWARDS LIFESCIENCES IRVINE; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): BD APM; 17200 lagauna canyon rd; irvine CA 92618
• Manufacturer Contact: erika bonilla ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 24206118
• Report Number: 2015691-2026-10624
• Device Sequence Number: 12139792
• Product Code: DQK
• UDI-Device Identifier: 00690103202762
• UDI-Public: (01)00690103202762(11)220222
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: NI
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2026

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
• Device Lot Number: 16803041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2026
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2026
• Supplement Date Received by Manufacturer: 03/06/2026
• Initial Report FDA Received Date: 01/28/2026
• Supplement Report FDA Received Date: 03/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/22/2022
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown