MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR ACUMEN IQ SENSOR; ADJUNCTIVE PREDICTIVE CARDIOVASCULAR INDICATOR

Model Number AIQS8R5

Device Problems Incorrect Measurement (1383); Inaccurate Information (4051)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/21/2023

Event Type  malfunction  

Manufacturer Narrative

No product was returned for evaluation; it was discarded at the hospital.Without the return of the product, it is not possible to determine if damages or defects existed on the product, nor could a root cause or potential contributing factors be identified.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 Description

As reported, during use in patient of this acumen iq sensor, primed under pressure, it was displayed lower mean arterial pressure (map) on the hemosphere monitor (around 60 mmhg), leading to the hpi alarming for an hypotensive event that never occurred since it was assessed based on the incorrect map displayed.There was no error message displayed for the incorrect map value.Map value was correctly shown on the bedside monitor.The patient was not treated according to the incorrect values.There was no allegation of patient injury.The device was not available for evaluation.Patient demographics unable to be obtained.

Manufacturer Narrative

Corrected data: h6 (device code).Added information to section d4 (expiration date) and h4 (device manufacturer date) and h6 (type of investigation) updated section h6 (component code), h6 (investigation findings) and h6 (investigations conclusion).The manufacturing records were reviewed for the lot number involved and there is no indication of a related nonconformance.All process parameters were met and inspections passed successfully.Images were received by the customer for review.Reported issue of abnormal waveform could be visually verified and confirmed through the image provided for investigation.However, it could not be confirmed if there is a potential defect in the product that could have cause the reported malfunction since no product sample was provided for investigation.Therefore, no further actions could be performed.There are manufacturing controls to avoid potential causes related to the related malfunction.

• Brand Name: ACUMEN IQ SENSOR
• Type of Device: ADJUNCTIVE PREDICTIVE CARDIOVASCULAR INDICATOR
• 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: 18491430
• MDR Text Key: 332637058
• Report Number: 2015691-2024-00277
• Device Sequence Number: 1
• Product Code: QAQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183646
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AIQS8R5
• Device Lot Number: 64311586
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/16/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/01/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1