MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR PRESSURE MONITORING KIT; TRANSDUCER, PRESSURE, CATHETER TIP

Model Number PX4X4

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); High Readings (2459); Pressure Problem (3012)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 10/15/2018

Event Type  malfunction  

Manufacturer Narrative

The device evaluation is anticipated.However the complaint cannot not be confirmed without the completion of a product evaluation.A supplemental report will be forthcoming with the evaluation and device history results when received.

Event Description

As reported, during a 9 hour redo cardiac surgery mitral valve replacement and disconnection of supra aortic trunks under extra corporeal circulation, a disposable pressure transducer (dpt) of quadruple assembly dpt overestimated the mean arterial pressure (map) by about 4 mmhg for 5 hours and 45 minutes (in the right radial artery).The dpt was exchanged in order to solve the issue.The clinician believed that the cerebral oximetry values were affected because of the inaccurate map values.The patient was transferred to the intensive care unit for the post-operative care.Two days later the patient woke up and was extubated.No neurologic deficits were noted.The patient has had ¿good evolution¿ 8 days post-operative.The device was available for evaluation.Patient demographics were not able to be obtained.The reporter stated that all equipment related to the pressure monitoring devices were philips devises "which are verified yearly and do not show any failure".

Manufacturer Narrative

One quadruple dpt kit was returned for examination.The reported event of "overestimated the mean arterial pressure" was not confirmed.The green labeled dpt zeroed and sensed pressure accurately on the ev1000 monitor.Pressure readings were stable during 8 hours of an output drift test.Electrical testing showed that both input and output impedances were within specifications.Zero-offset also met specification.No visible defect was observed from the kit.The three remaining returned dpts (red, blue and yellow) zeroed and sensed pressure accurately on the ev1000 monitor.Electrical testing on the three remaining dpt¿s pressure readings were also stable during 8 hours of an output drift test.Electrical testing showed that both input and output impedances were within specifications.Zero-offset also met specification.The reported event could not be confirmed or replicated during the analysis, as the device responded appropriately during functional testing.There was no evidence of a manufacturing nonconformance.No further actions will be taken at this time.No investigation will performed.A review of the manufacturing records indicated that the product met specifications upon release.Poor dynamic response can be caused by air bubbles, clotting, and excessive lengths of tubing, excessively compliant pressure tubing, small bore tubing, loose connections, or leaks.The assembly may be tested for dynamic response by observing the pressure waveform on an oscilloscope or monitor.Bedside determination of the dynamic response of the catheter, monitor, kit and transducer system is done after the system is flushed, attached to the patient, zeroed and calibrated.A square-wave test may be performed by pulling the snap tab device and releasing quickly.Pressure readings can change quickly and dramatically because of loss of proper calibration, loose connection, or air in the system.Pressure readings should correlate with the patient¿s clinical manifestations.It is unknown if user or procedural factors contributed to the stated event.In this event, there was no patient compromise noted.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.

Manufacturer Narrative

Reference capa-20-00141.

• Brand Name: PRESSURE MONITORING KIT
• Type of Device: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal ; DR
• MDR Report Key: 8070542
• MDR Text Key: 128412210
• Report Number: 2015691-2018-04690
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/25/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/15/2019
• Device Model Number: PX4X4
• Device Catalogue Number: PX4X4
• Device Lot Number: 60871685
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2018
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1