MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR PRESSURE MONITORING SET; PRESSURE MONITORING KIT

Model Number T001631A

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/13/2021

Event Type  malfunction  

Manufacturer Narrative

The device evaluation is anticipated.However, the complaint cannot not be confirmed without the completion of a product evaluation.A supplemental report will be forthcoming with the evaluation and device history results when received.

Event Description

It was reported that during flushing of this disposable pressure transducer (dpt) connected to an intra-cranial catheter, a leak occurred through a crack in the proximal stopcock.When the leakage was observed the stopcock was closed in order to stop it and realized the stopcock was cracked.User opened the stopcock again and an air bubble was shown, so it was closed again immediately and the whole circuit was replaced for another one.There was no allegation of patient injury.The device was available for evaluation.Patient demographics are not available.

Manufacturer Narrative

One single dpt kit together attached to a non-ew three-way stopcock and an additional non-ew iv line were returned for examination.The reported event of leak issue was confirmed however the leakage occurred from a non-edwards part.As received, a non-ew three-way stopcock was attached to distal male connector of the pressure line where stand-alone stopcock and distal pressure line were supposed to be assembled.A leakage was noticed from the non-edwards stopcock in one of the female luers through a crack of approximately 0.19" in length.The other female luer from the non-ew stopcock appeared cracked but did not leak.No leakage or damage was found from edwards unit during the leak test.As the evaluation has shown that this defect was from a non-edward device, this would not have been a reportable event.

Manufacturer Narrative

Patient demographics were not in the original report.

• Brand Name: PRESSURE MONITORING SET
• Type of Device: PRESSURE MONITORING KIT
• Manufacturer (Section D): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal
• MDR Report Key: 11352444
• MDR Text Key: 234235293
• Report Number: 2015691-2021-01349
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 03/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: T001631A
• Device Catalogue Number: T001631A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 57 YR