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 Problem Loss of consciousness (2418)

Event Date 01/18/2023

Event Type  Injury  

Manufacturer Narrative

As received heavy blood was found inside entire vamp plus system.Distal marvelous sample site was completely occluded with blood.Guidewire was used to clear blockages inside distal sample site and distal tubing male connector.Blood and clotting material were manually flushed out of vamp system using lab syringe prior to flush and pressure testing.The reported event of flushing issue was not able to be confirmed during evaluation.Kit was primed and flushed without any occlusion or flow restriction after removal of blood clots from vamp system.The reported event of wave form issue was also not able to be confirmed during evaluation.All three dpt sensors zeroed and sensed pressure accurately on hemosphere monitor.Electrical testing showed that both input impedances and output impedances were within specifications.Input and output impedance specifications for dpt sensor were 1,200 to 3,400 ohms and 285 to 315 ohms respectively.Zero offsets also met specification.Specification was from minus 25 to plus 25 mmhg.No visible damage was observed from the kit.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 a patient went unresponsive for a brief period of time while nurse was returning blood to the patient.Event occurred when nurse was drawing blood.Nurse had difficulties with patient arterial waveform and flushing prior to the event.Patient returned to baseline.Sales rep confirmed a pxvpl20001 was used in the cvicu.Per follow up with customer, lot number is unknown and no blood leakage was 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
• Manufacturer (Section G): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal ; DR
• Manufacturer Contact: jonathan diaz ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 16326737
• MDR Text Key: 309073518
• Report Number: 2015691-2023-10688
• 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: Nurse
• Type of Report: Initial
• Report Date: 02/08/2023

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: 01/27/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/18/2023
• Initial Date FDA Received: 02/08/2023
• 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