MAUDE Adverse Event Report: EDWARDS LIFE SCIENCE PRESSURE MONITOR SET; TRIPLE TRANSDUCER SETS

Catalog Number PXX

Device Problems Nonstandard Device (1420); Occlusion Within Device (1423)

Patient Problem No Patient Involvement (2645)

Event Date 08/05/2015

Event Type  malfunction  

Event Description

We have had 30+ defective transducer sets.The lumens that carry to flush solutions are partially or fully occluded.It's not consistent with each lumen.We had two different lot numbers that had this issue.Lot#60025936 and 59994227.The manufacturer was made aware right a way.A product recall was issued last week in regards to the issues we saw.Fortunately, none of these products reached the patient.

• Brand Name: PRESSURE MONITOR SET
• Type of Device: TRIPLE TRANSDUCER SETS
• Manufacturer (Section D): EDWARDS LIFE SCIENCE; irvine CA 92614
• MDR Report Key: 5041719
• MDR Text Key: 24589855
• Report Number: MW5055829
• Device Sequence Number: 1
• Product Code: DRS
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Report Date: 08/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/06/2017
• Device Catalogue Number: PXX
• Device Lot Number: 59994227
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1