MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR TRUWAVE DISPOSABLE PRESSURE TRANSDUCER WITH CONTINUOUS 3 ML/HOUR FLUSH DEVICE AN; TRANSDUCER, PRESSURE, CATHETER TIP

Model Number PX600F

Device Problems Display or Visual Feedback Problem (1184); Incorrect, Inadequate or Imprecise Result or Readings (1535); Infusion or Flow Problem (2964)

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

Event Date 05/06/2019

Event Type  malfunction  

Manufacturer Narrative

One single dpt sensor was returned for examination.The reported event of pressure measurement issue was not confirmed.As received, the dpt could be flushed without issues, zeroed and sensed pressure accurately on a pressure monitor.The pressure did not show any drift during output drift testing and met specification.Electrical testing showed that the dpt electronic components were intact as both input and output impedance were within specifications.Zero-offset also met specification.No visible defect was found from the dpt cable connector.The reported event could not be confirmed or replicated during the analysis, as the device responded appropriately during functional testing.It is not known if some procedural factors may have contributed to the event.There was no evidence of a manufacturing nonconformance.No further actions will be taken at this time.A review of the manufacturing records indicated that the product met specifications upon release.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 part of this monthly review.

Event Description

It was reported that after 2 hours of use, abnormal pressures were observed by the nurse.It was additionally reported when flushing the device, a flow problem occurred which led to the false pressure curve displayed on the screen.A new pressure transducer from the same lot was used and was able to flush without any difficulty, and the pressures noted were more plausible.No error message was displayed due to the issue and the patient was not treated off the abnormal values.The device is available for examination.

Manufacturer Narrative

Reference capa-20-00141.

• Brand Name: TRUWAVE DISPOSABLE PRESSURE TRANSDUCER WITH CONTINUOUS 3 ML/HOUR FLUSH DEVICE AN
• 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: 8654361
• MDR Text Key: 147952684
• Report Number: 2015691-2019-01901
• 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: 05/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/15/2021
• Device Model Number: PX600F
• Device Catalogue Number: PX600F
• Device Lot Number: 61846723
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2019
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1