MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, DR DISPOSABLE PRESSURE TRANSDUCER; PRESSURE MONITORING SET

Model Number PXVPP11351

Device Problem Contamination (1120)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

It was reported that an unknown sticky material was observed inside the vamp plus reservoir before use.There were no patient complications reported.

Manufacturer Narrative

The product has not been returned for evaluation.When it arrives and the product evaluation has been completed, a supplemental report will be submitted.The lot number was not provided; therefore, a review of the manufacturing records could not be completed.Complaint histories for all reported events are reviewed against trending control limits, and any excursions above the control limits are assessed and documented as part of this monthly review.

Manufacturer Narrative

A supplemental mdr is being submitted as a product evaluation and engineering evaluation was initiated for any manufacturing related processes which could be correlated to the complaint.The root cause is related to manufacturing.Sections g6, h2, h6: type of investigation, investigation findings, and investigation conclusions have been updated.The pressure monitoring set was returned for evaluation.A clear liquid like material was observed inside vamp plus reservoir.Procedure states that the vamp plus sub-assembly inside walls of body and plunger/cap interface to be lubricated with fluid silicone.No other visible inconsistency was observed throughout the kit during visual examination.This sample was sent to chemistry for further analysis.Per chemistry study the ir spectrum of the clear liquid like material inside vamp plus reservoir was consistent with that of rubber-silicone elastomer.All personnel involved were trained in accordance with procedure prior to when the lots were manufactured; however, a potential cause could be related to manpower, since, after the units go through the siliconizing process, the operator is required to insert the plunger into the body and carefully rotate it in and out to distribute the silicone throughout the body.In addition, visual inspection is required to ensure that there is no excess of silicone is observed inside the syringe; since the visual inspection process is performed manually and is human dependable, therefore, is an inherent risk associated with this activity, since, if the personnel are not properly focused, there is a risk of passing a unit with excess of silicone which can cause the reported failure.

• Brand Name: DISPOSABLE PRESSURE TRANSDUCER
• Type of Device: PRESSURE MONITORING SET
• Manufacturer (Section D): EDWARDS LIFESCIENCES, DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal
• Manufacturer (Section G): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal
• Manufacturer Contact: jonathan diaz ; 1 edwards way; irvine, CA 92614 ; 9492507258
• MDR Report Key: 18315264
• MDR Text Key: 330941090
• Report Number: 2015691-2023-18334
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K925638
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/07/2024

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: PXVPP11351
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/07/2023
• Initial Date FDA Received: 12/12/2023
• Supplement Dates Manufacturer Received: 03/07/2024
• Supplement Dates FDA Received: 03/07/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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