MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC. ACUMEN HYPOTENSION PREDICTION INDEX; ADJUNCTIVE PREDICTIVE CARDIOVASCULAR INDICATOR

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

Event Type  malfunction  

Event Description

A severe data analysis error was introduced in development and validation of product.The error makes it very likely that the model has no meaningful predictive ability.At the same time it causes a large overestimation of the reported predictive ability.The consequence of this is likely a very high rate of false positive alarms, and thereby a risk of overtreatment.The manufacturer was informed about this two years ago, and a detailed description of the problem was published one year ago (https://doi.Org/10.1097/aln.0000000000004320).

• Brand Name: ACUMEN HYPOTENSION PREDICTION INDEX
• Type of Device: ADJUNCTIVE PREDICTIVE CARDIOVASCULAR INDICATOR
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC.
• MDR Report Key: 18074194
• MDR Text Key: 327595204
• Report Number: MW5147773
• Device Sequence Number: 1
• Product Code: QAQ
• Combination Product (y/n): N
• Reporter Country Code: DA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1