MAUDE Adverse Event Report: EDWARDS LIFESCIENCES PXVFP11274; PRESSURE MONITORING SET

Model Number PXVFP11274

Device Problem Contamination (1120)

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

Event Type  malfunction  

Manufacturer Narrative

The product has been returned for evaluation.When the product evaluation has been completed, a supplemental report will be submitted.The device history review was completed and all inspections passed with no nonconformances.

Event Description

It was reported that an unknown material was found inside the vamp flex syringe before use.Further details such as what kind of material it was whether the package is opened or not and patient information could not be obtained.There were no patient complications reported.

Manufacturer Narrative

A supplemental mdr is being submitted due to product evaluation findings.Sections g6, h2, h6: type of investigation, investigation findings, and investigation conclusions have been updated.The (b)(4), pressure monitoring set was returned for evaluation.One white particulate was observed inside the vamp flex reservoir (floated in solution) during visual examination.The particulate was approximately 2 mm x 1 mm in size.The plunger of the vamp flex was pushed to a closed position at rate of 1ml per 1 second, but the particulate stayed inside vamp flex reservoir.It was recommended by ifu to move the plunger at rate of 1ml per 1 second.The whole line was flushed continuously for 5 minutes, but the particulate stayed inside vamp flex after 5 minutes of continuous flushing.No other visible inconsistency was observed on the returned kit.The particulate was removed from the reservoir, and the particulate appeared to be a gel-like material.Per chemistry study the ir spectrum of the white gel like material was consistent with that of poly (octadecyl acrylate).During the execution of the engineering evaluation process, it was identified that the involved component is manufactured by the "procedure products inc." supplier; since this unknown material showed similar absorption characteristics when comparing to poly (octadecyl acrylate) like material does not interaction during manufacturing process, therefore, this defect is considered as a supplier related condition and the corresponding supplier notification was sent due to mail by the dr supplier quality team.

• Brand Name: PXVFP11274
• Type of Device: PRESSURE MONITORING SET
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: jonathan diaz ; one edwards way; irvine, CA 92614
• MDR Report Key: 17987151
• MDR Text Key: 326300526
• Report Number: 2015691-2023-16993
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142749
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/18/2023

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: PXVFP11274
• Device Lot Number: YH0648MT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/29/2023
• Initial Date FDA Received: 10/23/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/06/2023
• 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