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

Model Number PXAVMP3

Device Problem Flushing Problem (1252)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/18/2019

Event Type  malfunction  

Event Description

Occurred on two sets of edwards triple transducer.One set pa transducer would not flush.Second set cvc would not flush.Minor delay in patient care due to need to provide additional setup.No patient harm.Affected products and remainder of lot number returned to warehouse manager.Used product and all product from affected lot was collected.Quality complaint was reported.Product will be sent to edwards lifesciences once rma is issued.

• Brand Name: TRUWAVE, VAMP
• Type of Device: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• MDR Report Key: 9165643
• MDR Text Key: 161521906
• Report Number: 9165643
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/25/2019

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: Health Professional
• Device Model Number: PXAVMP3
• Device Catalogue Number: PXAVMP3
• Device Lot Number: 61547359
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/25/2019
• Event Location: Hospital
• Date Report to Manufacturer: 10/08/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1