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

Model Number VO0144TTPL

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Defective Device (2588)

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

Event Date 01/16/2020

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 results when received.Lot number was not provided, therefore review of the manufacturing records could not be completed.

Event Description

It was reported that during use with a pressure monitoring kit, the value was 30 mmhg lower than the expected value.Which value had defect and the expected value were unknown.It was able to zero.The device was exchanged, and the problem was solved.The customer did not perform trouble shooting other than exchanging device.Occlusion, leakage, or kink was not noted with the device.A philips patient monitor was used.It is unknown whether the patient was treated based on the incorrect value or not and if the error message was indicated or not were unknown.Patient demographic information requested but unavailable.There were no patient complications reported.

Manufacturer Narrative

One pressure monitoring kit was received by our lab for evaluation.The reported event of pressure measurement issue was not confirmed.The dpt kit zeroed and sensed pressure accurately on the pressure monitor.The pressure did not show any signs of drifting during the output drift testing and met specifications.The electrical testing showed that both input and output impedance were within specifications.Zero-offset value also met specifications.There were no other visible defects on the dpt cable connector.Additional evaluation has been assigned for further investigation related to the manufacturing processes.A device history record review was completed and documented that device met all specifications upon distribution.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

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: 9671555
• MDR Text Key: 194785685
• Report Number: 2015691-2020-10388
• 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,Followup
• Report Date: 01/17/2020

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: 01/31/2021
• Device Model Number: VO0144TTPL
• Device Lot Number: LE0827MT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2020
• Initial Date Manufacturer Received: 01/17/2020
• Initial Date FDA Received: 02/05/2020
• Supplement Dates Manufacturer Received: 03/11/2020; 07/23/2020
• Supplement Dates FDA Received: 03/31/2020; 01/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1