MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR PRESSURE MONITORING SET (W/TRUWAVE DISPOSABLE PRESSURE TRANSDUCER & VAMP); CATHETER, CONTINUOUS FLUSH

Model Number PXVP2284DZ

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

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

Event Date 08/09/2021

Event Type  malfunction  

Manufacturer Narrative

One single dpt - vamp plus kit with saline bag was returned for examination.The reported event of inaccurate readings was not confirmed.The dpt zeroed and sensed pressure accurately on the laboratory pressure monitor.Pressure did not show any drift during output drift testing and met specifications.Electrical testing showed that both input impedance and output impedance were within specifications and the zero-offset also met specification.No leakage or occlusion was detected from the kit during pressure test.A device history record review was completed and documented that the device met all specifications upon distribution.As per ifu, 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 patients clinical manifestations.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.

Event Description

As reported, during use in a cardiac arrest patient with a disposable pressure transducer (dpt), the blood pressure measured 20-30mmhg higher than that measured by the cardiologist using acist.Before applying glyceryl trinitrate, the cardiologist measured the systolic pressure to be at 70mmhg while the edwards dpt measured 104mmhg.It was decided to administer glyceryl trinitrate while the nurse prepared noradrenaline in case it was needed.After the intervention, the monitoring sets were switched and the edwards dpt measured 20-30 mmhg higher again (see images in pdf attached).For the pressure readings, arteria radialis (respectively right and left side) were used.There was no allegation of patient injury.

• Brand Name: PRESSURE MONITORING SET (W/TRUWAVE DISPOSABLE PRESSURE TRANSDUCER & VAMP)
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal ; DR
• MDR Report Key: 12433395
• MDR Text Key: 270367188
• Report Number: 2015691-2021-05042
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• PMA/PMN Number: K181684
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial
• Report Date: 09/07/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 04/21/2023
• Device Model Number: PXVP2284DZ
• Device Catalogue Number: PXVP2284DZ
• Device Lot Number: 63759457
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/12/2021
• Initial Date FDA Received: 09/07/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/21/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 70