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

Model Number PL13A6TT

Device Problem Inaccurate Flow Rate (1249)

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

Event Date 05/27/2014

Event Type  malfunction  

Event Description

It was reported that although the pull tab was not pulled, the flow rate was high, like it was flushed during priming before use.It was also indicated that it was not used on the patient.There were no patient complications reported.

Manufacturer Narrative

We received one single dpt without any attached component.Leakage was detected at the dpt flush device during flow rate testing.Leakage occurred through a hole on the poppet and out of the flush device housing.The hole was at middle of what appeared to be misformed area on the poppet.The leakage or higher loss of priming solution (due to the leakage) might have contributed to customer experience of high flow rate.Flow rate testing through the flow restrictor could not be completed due to the leakage.This condition is related to supplier issue.(b)(4).

• 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: 3883900
• MDR Text Key: 4591136
• Report Number: 2015691-2014-01408
• 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: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/27/2014

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: PL13A6TT
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: 05/27/2014
• Initial Date FDA Received: 06/19/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/20/2014
• 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