MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR PRESSURE MONITORING KIT; TRANSDUCER, PRESSURE, CATHETER TIP

Model Number VO3509TSPL

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/10/2017

Event Type  malfunction  

Manufacturer Narrative

We received one single dpt kit with an iv set and pressure tubing for examination.The reported event of leakage issue was not confirmed.As received, all connections appeared tight and leakage was noted during a leak test.There was no visible damage/defect observed from the kit during a visual examination.Lot number was not provided, therefore review of the manufacturing records could not be completed.The reported event could not be confirmed or replicated during the analysis, as the device responded appropriately during functional testing.There was no evidence of a manufacturing nonconformance.No further actions will be taken at this time.A delay in surgery has the potential to lead to an adverse outcome.In this case, there were no patient complications reported.It is common clinical practice to check all connections before and periodically during use of this dpt monitoring system.It is not known if some user or procedural factors may have contributed to the event.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.

Event Description

It was reported that one of the connectors of the pressure monitoring kit was loose and leaked.The saline dropped into a power strip and triggered an electrical leakage alarm.The brain surgery was paused for less than 10 minutes due to this alarm.The operation was restarted and completed without incident.It could not be confirmed which connector was loosened or what device was connected to the power strip.There was no harm to the patient or hospital staff.Inquired of patient demographics but unable to be obtained.

• Brand Name: PRESSURE MONITORING KIT
• Type of Device: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal ; DR
• Manufacturer (Section G): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal
• Manufacturer Contact: lynn selawski ; 1 edwards way; irvine, CA 92614 ; 9497564386
• MDR Report Key: 6869342
• MDR Text Key: 86335999
• Report Number: 2015691-2017-02947
• 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: Other
• Type of Report: Initial
• Report Date: 08/24/2017

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: VO3509TSPL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2017
• Initial Date Manufacturer Received: 08/24/2017
• Initial Date FDA Received: 09/15/2017
• 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