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

Model Number PX600F

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Device Sensing Problem (2917)

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

Event Date 03/26/2020

Event Type  malfunction  

Manufacturer Narrative

One single dpt was returned for examination.The reported event of "issue with pressure measurement" was not confirmed.The dpt zeroed and sensed pressure accurately on the pressure monitor.Pressure did not show any drift during output drift test and met specification.Electrical testing showed that both input impedance and output impedance were within specifications.The was no visible defect was found from dpt cable connector.Lot number was not provided, therefore review of the manufacturing records could not be completed.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.Additional investigation has been assigned for evaluation.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 after disposable pressure transducer sensor zeroed but then the base line gradually came down to -20 mmhg, during use.Although the dpt sensor zeroed again, the same malfunction was observed later.There were no patient complications reported.Additionally it was reported that the waveform started coming down soon after the customer started the pressure monitoring.Patient demographics are unavailable.

Manufacturer Narrative

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

• Brand Name: TRUWAVE DISPOSABLE PRESSURE TRANSDUCER WITH CONTINUOUS 3 ML/HOUR FLUSH DEVICE
• 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: 9980001
• MDR Text Key: 193274744
• Report Number: 2015691-2020-11524
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• PMA/PMN Number: B115636
• 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: 03/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PX600F
• Device Catalogue Number: PX600F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2020
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1