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

Model Number	AIQS85
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	Shock (2072)
Date of Event	12/18/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was discarded at the facility.Without the return of the product, it is not possible to determine if damages or defects exist on the product, nor can any manufacturing nonconformance, failure mode, root cause, or potential contributing factors be identified.No actions will be taken at this time.A device history record review was completed and documented that the device met all specifications upon distribution.Complaint histories for all reported events are reviewed against trending control limits, and any excursions above the control limits are assessed and documented as part of this monthly review.
Event or Problem Description
It was reported that an acumen aiqs85 was displaying inaccurate values as compared to the swan-ganz catheter placed on post-op day - pod 4.During the or procedure, the patient had instability and was unreactive to anti-hypotensive meds per the acumen iq readings.Throughout the course of 3 days post-op, the patient parameters continued to indicate vasoplegic shock and was treated with multiple types of anti-hypotensive meds.An echo showed that the ejection fraction had gone from 40 percent in the or to 28 percent.Pod 4, the patient was reintubated and a swan-ganz catheter was placed through the introducer.Per the swan-ganz catheter and verified by fick calculation, the parameters indicated the patient was in cardiogenic shock.The most recent update reported that the patient is in the icu with a balloon pump.Troubleshooting was not done as no problem was recognized until the swan-ganz catheter was placed.When the swan was placed, the acumen was no longer utilized.The patent required cardiac catheterization, reintubation, and extubation.The surgeon stated in conversation with the sales representative that once the patient started to decompensate after pod 1, a swan-ganz should have been inserted at that time.The surgeon has noted improved patient outcomes and decreased length of stay since they began using acumen iq on his patients.The device is not available for return.

• Brand Name: ACUMEN IQ SENSOR
• Common Device Name: 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: katheryn richards ; 1 edwards way; irvine, CA 92614 ; 9492017706
• MDR Report Key: 18485476
• Report Number: 2015691-2024-00253
• Device Sequence Number: 2820695
• Product Code: QAQ
• UDI-Device Identifier: 00690103200942
• UDI-Public: (01)00690103200942(17)250912(11)230913(10)65311182
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K183646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 01/10/2024

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: 09/12/2025
• Device Model Number: AIQS85
• Device Lot Number: 65311182
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2023
• Initial Report FDA Received Date: 01/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/13/2023
• 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: 80 YR
• Patient Sex: Unknown
• Patient Weight: 89 KG