MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC TRUWAVE, VAMP PLUS; TRANSDUCER, PRESSURE, CATHETER TIP

Model Number	PXVP2284
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
An arterial line and pressure bag was connected to a draw system that linked to patient's picc line.The drip chamber began leaking specifically below the white spike material and the clear plastic drip chamber.After the pressure bag/draw system was setup; a small puddle was noticed on the floor from the dripping.The picc line connected to the tubing and draw system was locked and never came into contact with unsterile materials.This good catch resulted in no patient harm.The leaking pressure system was changed out and the new tubing and drip chamber had no leak.The set is available for return to the manufacturer for inspection.Manufacturer to contact writer with return information.

• Brand Name: TRUWAVE, VAMP PLUS
• Common Device Name: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• MDR Report Key: 16952659
• Report Number: 16952659
• Device Sequence Number: 17895799
• Product Code: DXO
• UDI-Device Identifier: 07460691950177
• UDI-Public: 07460691950177
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/28/2023
• Report Date (Section F): 04/28/2023

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 Model Number: PXVP2284
• Device Catalogue Number: PXVP2284
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 05/18/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/18/2023
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 04/28/2023