MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR PRESSURE MONITORING SET (W/TRUWAVE DISPOSABLE PRESSURE TRANSDUCER & VAMP); CATHETER, CONTINUOUS FLUSH

Model Number PXVP2284DZ

Device Problems Incorrect Measurement (1383); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/29/2021

Event Type  malfunction  

Manufacturer Narrative

One single dpt vamp plus kit was received by our product evaluation laboratory for a full examination.The report of pressure readings issue was not able to be confirmed.Dpt zeroed and sensed pressure accurately on pressure monitor.Pressure did not show any drift during output drift testing and met specification.Electrical testing showed that both input impedance and output impedance were within specifications.Zero-offset also met specification.No leakage or occlusion was detected from the kit during pressure test.The manufacturing records were reviewed and there is no indication of a related nonconformance.All process parameters were met and inspections passed successfully.As per ifu, 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 patients 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

As reported, as a control study in a patient who was intubated in the cardiology lab after he had a heart arrest and was resuscitated, using a disposable pressure transducer with vamp, the blood pressure measured 167/67 mmhg while that of the cardiologist using acist in the aorta measured 145/55 mmhg.After the examination ended, the edwards transducers measured 151/63 mmhg while that cardiologist measured 120/52 mmhg in the arterial radius.With the non-invasive blood pressure monitoring, it measured 120/47 mmhg.There was no allegation of patient injury.The device was available for evaluation.

Manufacturer Narrative

The following additional information was received.The invasive blood pressure measured by the nurse was from the left radial arteria; however, the blood pressure measured by the cardiologist is from the aorta or right radial arteria.A non-invasive blood pressure monitoring was required after the examination to be compared with the blood pressure value obtained by edwards dpt and the one measured by the cardiologist.The non-invasive blood pressure measurement was closer to the blood pressure measured by the cardiologist, and much lower than the invasive blood pressure measured by the nurse using edwards dpt.Additionally, the patient was treated with noradrenaline, but not as a consequence of the incorrect measurements of edwards dpt.The age of the patient was also added, and two adverse event problem codes in h6 were updated.

• Brand Name: PRESSURE MONITORING SET (W/TRUWAVE DISPOSABLE PRESSURE TRANSDUCER & VAMP)
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 12524851
• MDR Text Key: 273099459
• Report Number: 2015691-2021-05320
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181684
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/01/2021

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: 04/21/2023
• Device Model Number: PXVP2284DZ
• Device Catalogue Number: PXVP2284DZ
• Device Lot Number: 63759457
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/01/2021
• Initial Date FDA Received: 09/24/2021
• Supplement Dates Manufacturer Received: 11/12/2021
• Supplement Dates FDA Received: 12/01/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/21/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 90 KG