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

Model Number PXVPL20001

Device Problem Use of Device Problem (1670)

Patient Problems Loss of consciousness (2418); Insufficient Information (4580)

Event Type  Injury  

Event Description

It was reported a patient experienced neurological activities such as seizure activities or temporary loss of consciousness during the line flush of a pressure monitoring device.Patient was getting prepped for an arterial blood gas drawing.Customer noted the patient was awake and neurologically intact.Customer believed the event may be caused by possible air embolism with the art line set up or user error due to turn over of nurses.Incident occurred either in the radial or brachial arterial line.Details are unknown.Hospital does not heparinize flush bags and all flush bags are pressurized throughout use of arterial line.Patient was in the cvicu and event occurred post operative.Customer commented that nurses do not power flush.Patient did not experience any long term consequences.

Manufacturer Narrative

The device was not returned for evaluation.Without return of the unit it is not possible to determine if some damage or defect existed on the unit that could have contributed to the event.Further evaluation regarding related quality issues is under investigation.The lot number was not provided thus a device history record was not reviewed.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

During the week of december 21, 2022 a site visit was completed by edwards product quality clinician, product safety physician and sales rep.It was discussed that there has been a large amount of turnover in the nursing personnel in the past two years.Nursing in service on the correct use of model pxvpl20001 was held during the week.Upon rounding, edwards personnel noticed majority of the arterial lines had the stopcocks in the flushing position during monitoring and a number of left sided arterial lines had extension tubing of 12 inches or more.Hospital physician has also seen stopcocks in the incorrect position.The facility was informed that the stopcock handle in the incorrect position during monitoring and the addition of extension tubing of 12 inches or more can affect the dynamic response resulting in overdamped or underdamped waveforms and inaccurate systolic and diastolic values.Edwards dpt pressure lines are tested for dynamic response up to 96 inches and this model is 85 inches.

• 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
• Manufacturer (Section G): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal
• Manufacturer Contact: jonathan diaz ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 16023998
• MDR Text Key: 305908403
• Report Number: 2015691-2022-10207
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: PXVPL20001
• Device Catalogue Number: PXVPL20001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/29/2022
• Initial Date FDA Received: 12/21/2022
• Supplement Dates Manufacturer Received: 12/21/2022
• Supplement Dates FDA Received: 01/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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