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	11/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.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.
Event or Problem Description
As reported, during use this acumen fluid meter did not initialize and displayed bolus volume administered and the error message "flow rate detected too high", even thought the line was closed and no bolus had been injected into the patient since as per user best practices the line is not opened until the system indicates that a bolus can be injected.Cable was disconnected and reconnected several times and also replaced with a new one without success.The issue was solved when the fluid meter was changed.There was no allegation of patient injury.Patient demographics were unable to be obtained.
Additional Manufacturer Narrative
Added information to section h6 (type of investigation) updated section h6 (component code), h6 (investigation findings) and h6 (investigations conclusions).The device was received for evaluation.The report of "acumen fluid meter did not initialize and displayed bolus volume administered and the error message "flow rate detected too high" was confirmed.Flow meter did not register flow rate.Flow meter initialized but did not register flow rate.No visible damage was observed from the sensor or the unit.The manufacturing records were reviewed for the lot involved and there is no indication of a related nonconformance.All process parameters were met and inspections passed successfully.Further investigation was perfomed at the manufacturing site.Based on the assessment performed, it can be concluded that there is no objective evidence that reported defects were caused during the manufacturing process.During manufacturing process there are mitigations to avoid this condition.Nevertheless, a personnel acknowledgment related to this complaint was provided to the manufacturing personnel.

• 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 ; 9492503939
• MDR Report Key: 23726162
• Report Number: 2015691-2025-09782
• Device Sequence Number: 18823117
• Product Code: DQK
• UDI-Device Identifier: 00690103205824
• UDI-Public: (01)00690103205824(17)260313(11)240313(10)65652662
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2026

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 Expiration Date: 03/13/2026
• Device Model Number: AIQFM10
• Device Lot Number: 65652662
• 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: 11/14/2025
• Supplement Date Received by Manufacturer: 02/16/2026
• Initial Report FDA Received Date: 12/05/2025
• Supplement Report FDA Received Date: 02/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/13/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown