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 10/27/2019

Event Type  malfunction  

Manufacturer Narrative

One single dpt kit was returned for examination.The reported event of "inaccurate values" was not confirmed.The dpt zeroed and sensed pressure accurately on the patient monitor.The pressure did show drifting during output drift testing but met specification.Electrical testing showed that the dpt electronic components were intact because both input and output impedance were within specifications.Zero-offset also met specification.However, the zero-stopcock male luer had been broken and the broken luer was stuck inside of the mating pressure tubing female connector.Indications of what appeared to be bonding material were found on the broken luer.The px260 kit did not call for bonding between the zero-stopcock and pressure tubing female connector.No other visible damage was observed from the rest of the kit.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint and implement any necessary corrective actions.A supplemental report will be forthcoming when the device history results are received.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 the disposable pressure transducer displayed inaccurate values during use.There was no allegation of patient injury.The product was available for evaluation.Patient demographics were unavailable.

Manufacturer Narrative

Further follow up with the customer indicated that the issue was not related to inaccurate values but to no value being displayed.This is not considered a reportable event.

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: 9312148
• MDR Text Key: 194598466
• Report Number: 2015691-2019-04185
• 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: 10/27/2019

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: 61543205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2019
• Initial Date Manufacturer Received: 10/27/2019
• Initial Date FDA Received: 11/12/2019
• Supplement Dates Manufacturer Received: 12/13/2019; 07/23/2020
• Supplement Dates FDA Received: 01/03/2020; 01/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1