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 High Blood Pressure/ Hypertension (1908); Memory Loss/Impairment (1958); Muscle Weakness (1967); Loss of consciousness (2418); Low Oxygen Saturation (2477)

Event Type  Injury  

Event Description

It was reported the patient became unresponsive while nurse was reinjecting the waste blood from the closed syringe of a pressure monitoring device.Lines were in the right brachial arteries during the event.Prior to incident, the patient was awake and speaking with the nurse while an abg sample was being drawn.After the sample was collected, patient became unresponsive to voice and pain while nurse was reinjecting blood.Physician and additional nurses were called in to examine patient and noted that the patient was unresponsive to stimuli, hypertensive, and desaturated significantly.Patient had normal bp prior to symptoms.No interventions were needed because patient started becoming responsive.Patient began responding to commands without vocalizing and her right grip was weaker than her left.Eventually, patient fully awakened, spoke normally, and had equal motor strength bilaterally, with no apparent residual deficits.Bp and spo2 also returned to normal.Patient did not remember the event.Incident occurred in the cvicu and happened post operative.Event occurred prior to flushing the tubing with the transducer pull tab and the line was never flushed.Only reinfusion of reservoir fluid was performed when event occurred.Physician also checked and confirmed that tubing had no air.Entire episode was estimated to last about 10 to 12 minutes.Transducer was removed and collected the next day.Hospital does not heparinize flush bags and all flush bags are pressurized throughout use of arterial line.

Manufacturer Narrative

The reported event of possible air in the device was not able to be confirmed.As received, priming solution was visible inside the kit.Blood was visible inside pressure tubing and at connection between distal tubing connector and iv catheter.Additional dpt and one way stopcock were found attached to the kit when compared to drawing for reported model pxvpl20001.Kit was primed and flushed without any problem.No leakage was observed from the kit during leak test.All dpt sensors zeroed and sensed pressure accurately on hemosphere monitor.Water was drawn into vamp plus reservoir from the patient side of the kit and also returned back to patient side at the rate 1cc per second as instructed by edwards ifu to test for any leakage into the system.No leakage was detected across vamp system.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: 16019565
• MDR Text Key: 305870451
• Report Number: 2015691-2022-10189
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/30/2022
• Initial Date FDA Received: 12/20/2022
• Supplement Dates Manufacturer Received: 12/21/2022
• Supplement Dates FDA Received: 01/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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 Sex: Female