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

Model Number VO4401TSA(PL)_

Device Problems Decrease in Pressure (1490); 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 07/17/2018

Event Type  malfunction  

Manufacturer Narrative

One single flothru dpt-vamp flex kit with iv set and pressure tubing were returned for examination.The reported event of pressure measurement issue was not confirmed.The dpt zeroed and sensed pressure accurately on a pressure monitor.The pressure did not show any drift during output drift testing and met specifications.Electrical testing showed that both input and output impedance were within specifications.Zero-offset also met specification per the ifu.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.There was no evidence of a manufacturing nonconformance.No further actions will be taken at this time.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 a 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 event.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 while using a disposable pressure transducer kit with vamp flex, the pressure value indicated on the monitor was lower than the customer expected during use.It is not known what the readings or expected reading were.There was no information provided on whether the patient was treated based on the incorrect value.There was no occlusion, leakage or kink noted on the device.Patient demographic information requested but unavailable.No patient complications were reported.

Manufacturer Narrative

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

• 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: 7766072
• MDR Text Key: 117009712
• Report Number: 2015691-2018-03276
• 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: 07/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VO4401TSA(PL)_
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2018
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1