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

Event Date 05/21/2020

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

It was reported that during use, this disposable pressure transducer (dpt) showed central venous pressure (cvp) value that was doubled.The value provided was 25, however the doctor expected 12.The dpt kit was exchanged to a new one and the value was then correct.The patient was not treated according to wrong values.It was unknown if any error messages were displayed.There was no allegation of patient injury.The device was available for evaluation.Patient demographic information is unavailable.

Manufacturer Narrative

One single dpt kit was received for evaluation.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 and met specifications.Electrical testing showed that both input impedance and output impedance were within specifications.No leakage or occlusion was detected from the kit during pressure test.No visible damage was observed from the kit.A device history record review was completed and documented that device met all specifications upon distribution.A supplement report will be sent if any non conformances are found related to the manufacturing processes.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.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

• 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: 10149930
• MDR Text Key: 195707769
• Report Number: 2015691-2020-12158
• 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,Followup
• Report Date: 05/22/2020

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 Expiration Date: 01/13/2022
• Device Model Number: PX260
• Device Catalogue Number: PX260
• Device Lot Number: 62763890
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2020
• Initial Date Manufacturer Received: 05/22/2020
• Initial Date FDA Received: 06/12/2020
• Supplement Dates Manufacturer Received: 07/24/2020; 07/23/2020
• Supplement Dates FDA Received: 08/01/2020; 01/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1