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
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.
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 30 points different in the systolic pressure.For the map the difference could be 10 up to 20 points difference.The patient had a brachial oscillometric cuff on the same side as the acumen cuff.There was no patient injury.
Additional Manufacturer Narrative
One hemosphere clearsight module was returned for evaluation.The customer report of inaccurate values was not confirmed.Engineering connected the hemcsm10 to a known working hem1 hot mock-up system.The hemcsm10 caused no errors.It was also able to obtain normal bp readings and waveform.Monitored for 1 hour and the blood pressure readings remained stable for the duration.No physical damage was found.The device history record review was completed and the product passed without any nonconformances.An engineering evaluation was initiated to assess for any manufacturing related processes which could be correlated to the complaint.As no defect was found with the device, the root cause of the alleged complaint is unable to be determined at this time nor is there evidence that supports or confirms the failure mode is associated to a manufacturing/design defect that would have contributed to the reported event.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 laguna canyon rd; irvine CA 92618
• Manufacturer Contact: erika bonilla ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 24206120
• Report Number: 2015691-2026-10623
• Device Sequence Number: 14830116
• Product Code: DQK
• UDI-Device Identifier: 00690103202762
• UDI-Public: (01)00690103202762(11)220223
• Combination Product (Y/N): N
• 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): 03/02/2026

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: 16803073
• 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: 02/17/2026
• Initial Report FDA Received Date: 01/28/2026
• Supplement Report FDA Received Date: 03/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/23/2022
• 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