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

Model Number VO1318TSPL01

Device Problem Particulates (1451)

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

Event Date 12/16/2014

Event Type  malfunction  

Event Description

It was reported that an unknown material was found inside the pressure tubing before use.There were no patient complications reported.

Manufacturer Narrative

The device evaluation is anticipated.However, at this time the complaint could not be confirmed without the product.A supplemental report will be submitted with the final investigation results.

Manufacturer Narrative

Received one single dpt-vamp flex kit with iv set and pressure tubing for evaluation.A review of the manufacturing records indicated that the product met specifications at the time of release.One white particulate was found inside of the pressure tubing.The particulate remained in the same location during flushing of the kit.The particulate was removed and sent to chemistry for further analysis.Chemistry results concluded that the white substance showed similar absorption characteristics when compared to cellulose like material.

• 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: lynn selawski ; 1 edwards way; irvine, CA 92614 ; 9497564386
• MDR Report Key: 4359085
• MDR Text Key: 5180357
• Report Number: 2015691-2014-03130
• 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: Literature,Health Professional,User Facility,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/17/2014

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: VO1318TSPL01
• Device Lot Number: EN1079MT
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/17/2014
• Initial Date FDA Received: 12/23/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/03/2015
• 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