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

Model Number PXVFL10790

Device Problem Leak/Splash (1354)

Patient Problem Exposure to Body Fluids (1745)

Event Date 07/29/2021

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for evaluation since it was discarded at the facility.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.It is not known if some procedural factors may have contributed to the event.No corrective actions will be taken at this time.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.

Event Description

It was reported that blood was splashed out from the septum of lass sampling site when the syringe was drawn out from lass on the first day of use.It was when the customer was changing the patient's body position after connecting a-line, blood splashed out on the surgical doctors eyeball.An infection check was performed and there was no health hazard to the doctor so far.The amount of blood leakage is unknown.No additional treatment to the patient was needed.No extension of hospitalization was caused.It is unknown whether the patient is an adult or a peds.The customer suspected the issue could be related to lass structure since the event occurred even though the customer draw out the syringe at pressure monitoring position in accordance with the recommended procedure by ew.In addition, the customer commented that to set pressure monitoring position may increase pressure in the septum and as a result, blood splashed out when the syringe was drawn out.The device was discarded at the hospital.Although there was blood leakage observed, there were no patient complications reported.

• 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: 12338981
• MDR Text Key: 267345198
• Report Number: 2015691-2021-04736
• 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: foreign,other,user facility
• Type of Report: Initial
• Report Date: 08/18/2021

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: No Information
• Device Model Number: PXVFL10790
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/29/2021
• Initial Date FDA Received: 08/18/2021
• 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