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	05/26/2025
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, when performing the bolus with this fluid meter, the fluid was infused correctly but it was not tracked.Later, it detected the passage of fluid when every line was closed and nothing was being injected.There was no incorrect fluid administration to the patient; there was no allegation of patient injury.
Additional Manufacturer Narrative
Updated section h6 (investigation findings) and h6 (investigations conclusions).Finally, the device was not received for evaluation since it was discarded at hospital.Without return of the product, a complete investigation of the reported event is unable to be performed.It is not possible to determine what factors may have contributed to it, and therefore no actions could be planned.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.There are manufacturing controls to avoid potential causes related to the related malfunction.

• 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: 22165407
• Report Number: 2015691-2025-04675
• Device Sequence Number: 7957906
• Product Code: DQK
• UDI-Device Identifier: 00690103205824
• UDI-Public: (01)00690103205824(17)260301(11)240301(10)65623116
• 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): 07/24/2025

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: 03/01/2026
• Device Model Number: AIQFM10
• Device Lot Number: 65623116
• Was Device Available for Evaluation?: No
• 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: 05/26/2025
• Supplement Date Received by Manufacturer: 07/23/2025
• Initial Report FDA Received Date: 06/09/2025
• Supplement Report FDA Received Date: 07/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/01/2024
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 41 YR
• Patient Sex: Male
• Patient Weight: 73 KG