MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR CUSTOM DEFINED PRODUCT; TRANSDUCER, PRESSURE, CATHETER TIP

Model Number VO3906TSPL03

Device Problem Particulates (1451)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/25/2016

Event Type  malfunction  

Manufacturer Narrative

The lot number was not provided; therefore, a review of the manufacturing records could not be completed.A supplemental report of the evaluation will be forthcoming when the results are completed.

Event Description

It was reported that an unknown particulate was found inside or on the device during use.Details are unknown at the moment.There were no patient complications reported.

Manufacturer Narrative

Received one single flothru dpt-vamp flex kit with iv set and pressure tubing.No visible particulate was observed throughout the kit, especially dpt fluid path.The kit was flushed continuously with ro water at pressure 345 mmhg for 5 minutes.The ro water was filtered to scan for particulate and no particulate was found on the filter paper.

• Brand Name: CUSTOM DEFINED PRODUCT
• Type of Device: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): EDWARDS LIFESCIENCES DR; carretera sanchez, km 18 1/2; parque ind. de itabo; haina. san cristobal ; DR
• Manufacturer (Section G): EDWARDS LIFESCIENCES DR; carretera sanchez, km 18 1/2; parque ind. de itabo; haina. san cristobal ; DR
• Manufacturer Contact: brian hurd-servin ; 1 edwards way; irvine, CA 92614 ; 9492506423
• MDR Report Key: 5445423
• MDR Text Key: 38538374
• Report Number: 2015691-2016-00479
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/26/2016

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: VO3906TSPL03
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/26/2016
• Initial Date FDA Received: 02/18/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/14/2016
• 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