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

Model Number PX260

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/24/2020

Event Type  malfunction  

Manufacturer Narrative

One single dpt kit was received for evaluation.The reported event of inaccurate values was confirmed.Dpt sensor did not zero nor sense pressure on ev1000 monitor.Error message "selected cvp zero point out of tolerance.Check dpt" was showed on ev1000 monitor.Electrical testing showed that both input impedance and output impedance of dpt sensor were within specifications.However, zero-offset value did not meet the specification.No visible damage or defect was observed from sensor chip, solder joints, cable and cable connector.Electrical testing and visual examination suggested the out of specification condition was within the sensor chip.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.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 a part of the monthly review.

Event Description

It was reported that during use in patient of this disposable pressure transducer, the central venous pressure (cvp) displayed was not correct.The expected value according to the clinical patient status was between 0-12 mmhg.However the value showed persistently without any fluctuation was 40 mmhg.Additionally, cvp waveform was not displayed.There was no error message or alarm.Replacing the dpt for another one the issue was solved.There was no allegation of patient injury.The device was available for evaluation.Patient demographics are not available.

Manufacturer Narrative

It was initially reported that the cvp value was incorrect without a wave form present.In the case, of physiologic parameter displaying without a waveform present, the user would be prompted to troubleshoot, as a waveform should always be present with the cvp values.This serves as a correction and the complaint no longer meets the criteria as reportable.

• Brand Name: PRESSURE MONITORING KIT WITH TRUWAVE DISPOSABLE PRESSURE TRANSDUCER
• 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: 11040922
• MDR Text Key: 224412749
• Report Number: 2015691-2020-15097
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• PMA/PMN Number: K925638
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/02/2020

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 Model Number: PX260
• Device Catalogue Number: PX260
• Device Lot Number: 63146873
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2020
• Initial Date Manufacturer Received: 12/02/2020
• Initial Date FDA Received: 12/18/2020
• Supplement Dates Manufacturer Received: 12/02/2020
• Supplement Dates FDA Received: 12/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1