MAUDE Adverse Event Report: EDWARDS LIFESCIENCES CLEARSIGHT PRESSURE CONTROLLER KIT

Model Number	PC2K
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2024
Type of Reportable Event	Malfunction
Additional 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 results become available.The device history record review was completed and all inspections passed with no non-conformances.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 blood pressure was low when using a pc2k.They exchanged it with the reps equipment with same hrs and cuff and the blood pressure was correct.90/54 were the low numbers and the expected with the switch was 128/84.No patient treatment was applied because there was another blood pressure monitoring device placed.No damage noted.There is no patient injury.Patient demographics were unavailable.
Additional Manufacturer Narrative
No product was returned for evaluation.Without return of the unit, it is not possible to determine if some damage or defect existed on the unit that could have contributed to the event.It is not known if some procedural factors may have contributed to the event.
Additional Manufacturer Narrative
One pressure controller was returned for evaluation.When connected to a known working hemosphere system, cuff port 1 functioned as expected with the readings within limits.Cuff port 2 would not recognize the cuff simulator being connected.When the device was opened contamination was found on the cuff 2 side.An engineering evaluation was initiated to assess for any manufacturing-related processes which could be correlated to the complaint.Based on the available information there is no evidence that supports or confirms the failure mode is associated to a manufacturing or design defect.Unintended use error caused or contributed to this event.

• Brand Name: CLEARSIGHT PRESSURE CONTROLLER KIT
• Common Device Name: PRESSURE CONTROLLER KIT
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: erika bonilla ; one edwards way; irvine, CA 92614
• MDR Report Key: 20789181
• Report Number: 2015691-2024-09006
• Device Sequence Number: 7809925
• Product Code: DXN
• UDI-Device Identifier: 00690103193473
• UDI-Public: (01)00690103193473(11)230920
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K140312
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/15/2025

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 Model Number: PC2K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 11/11/2024
• Supplement Date Received by Manufacturer: 12/20/2024; 04/03/2025
• Initial Report FDA Received Date: 11/26/2024
• Supplement Report FDA Received Date: 01/08/2025; 04/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown