MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR ACUMEN IQ FLUID METER; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number	AIQFM10
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during use in patient, with this hemosphere fluid meter connected to a hemosphere monitor, the volume of fluid was not tracked (see video attached).It was disconnected and connected several times but the issue remained.It was solved replacing the device.There was no allegation of patient injury.The device was available for evaluation.
Additional Manufacturer Narrative
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 part of this monthly review.The product is expected to be returned for analysis; however, it has not yet been received.Upon the return of the product a supplemental report will be sent with the investigation results.

• Brand Name: ACUMEN IQ FLUID METER
• Common Device Name: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal
• Manufacturer (Section G): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492017706
• MDR Report Key: 24684767
• Report Number: 2015691-2026-13491
• Device Sequence Number: 13265532
• Product Code: DQK
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K223865
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2026

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
• Device Model Number: AIQFM10
• Device Lot Number: 65997477
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2026
• Supplement Date Received by Manufacturer: 06/08/2026
• Initial Report FDA Received Date: 03/25/2026
• Supplement Report FDA Received Date: 06/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/08/2024
• 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: Initial
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Weight: 62 KG