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

Model Number AIQS6AZ5

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 02/20/2024

Event Type  malfunction  

Manufacturer Narrative

The device evaluation is anticipated.However, the complaint cannot be confirmed without the completion of a product evaluation.A supplemental report will be forthcoming when the investigation is completed.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 a part of the monthly review.

Event Description

It was reported that an acumen iq sensor had pressure value discrepancy.Values from the sensor were different compared to the bp cuff.It was confirmed that the sensor was successfully set up and zeroed.Inaccurate values were displayed after set up.There were no patient injuries.

Manufacturer Narrative

A product evaluation was completed with the returned acumen iq unit.The reported event of "zeroing difficulty" was confirmed.Dpt sensor of acumen iq unit did not zero nor sensed pressure on pressure monitor.Report of pressure value discrepancy was due to zeroing difficulty.Electrical testing showed that both input and output impedance were unstable if measured from dpt sensor cable connector.However electrical testing showed that both input impedance and output impedance measured from the sensor chip were within specifications.Corrosion and presence of moisture were observed on and underneath contact plates of dpt sensor cable connector.Corrosion was likely caused by liquid.It was warned by ifu not to expose electrical connections to fluid contact.Acumen iq sensor zeroed and sensed pressure accurately on pressure monitor.An engineering evaluation was initiated to assess for any manufacturing related processes which could be correlated to the complaint.According to the product evaluation, the corrosion was likely caused by liquid.The manufacturing process was reviewed, and it was identified that this defect could not have happened since during the assembly process there are no liquids to which the component affected by this defect can be exposed.As part of the manufacturing process current control measures include, 100 percent visual inspection, electrical test, and capacitance test.Therefore, no specific root cause could be identified.Per the ifu, it states, "do not expose electrical connections to fluid contact.May result in electrical shock to user or patient, and/or arrhythmia".A device history record review was completed and documented that device met all specifications upon distribution.

• 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 ; DR
• Manufacturer (Section G): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal ; DR
• Manufacturer Contact: jonathan diaz ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 18861045
• MDR Text Key: 337430828
• Report Number: 2015691-2024-01880
• 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: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: AIQS6AZ5
• Device Lot Number: 65457566
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/20/2024
• Was Device Evaluated by Manufacturer?: No
• 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