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

Model Number VO4602TWPL

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

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

Event Date 11/12/2020

Event Type  malfunction  

Manufacturer Narrative

One double flothru dpt kit with iv set and pressure tubing was returned for evaluation.Iv tube was cut and the spike was not returned for evaluation.Pressure tubing on blue line remained coiled with paper band.Non-ew sample site with attached terumo 20ml syringe was attached at distal end of the kit on blue line.The reported event of pressure measurement issue was not confirmed.The dpt zeroed and sensed pressure accurately on the pressure monitor.Pressure did not show any drift during output drift testing.Electrical testing showed that both input impedance and output impedance were within specifications.No visible defect was found from dpt cable connectors.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 not known if user or procedural factors may have 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 a part of the monthly review.

Event Description

It was reported that left ventricle pressure value and aortic pressure value were inaccurate on the first day of use.It was expected that left ventricle pressure value would be higher than aortic pressure value while value shown on the monitor was unknown.There was no problem with shape of pressure waveform.The value and the waveform matched.The patient was not treated based on the incorrect value.The dpt zeroed before use.The data log was not provided.The device was not exchanged and the customer did not perform anything for trouble shooting.No error message was shown.Occlusion, leakage or kink on the device were not observed.A nihon kohden patient monitor was used.There were no patient complications reported.The customer commented although calibration was performed and dpt sensed pressure, it seemed that each value of the double line kit deviated from normal value.Patient demographic information was requested but unavailable.

Manufacturer Narrative

A device history record review was completed and documented that device met all specifications upon distribution.

• 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: 10946423
• MDR Text Key: 219537113
• Report Number: 2015691-2020-14827
• 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
• Report Date: 11/13/2020

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: VO4602TWPL
• Device Lot Number: NK0695MT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2020
• Initial Date Manufacturer Received: 11/13/2020
• Initial Date FDA Received: 12/04/2020
• Supplement Dates Manufacturer Received: 12/18/2020
• Supplement Dates FDA Received: 12/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1