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

Model Number PXMK10649

Device Problem Contamination (1120)

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

Event Date 11/02/2022

Event Type  malfunction  

Manufacturer Narrative

The reported event of contamination issue was confirmed.One unknown clear material was observed inside pressure tubing at approximately 30 cm from zero stopcock.The material was approximately 2 x 1 mm in size.The material was moved to stand alone three way stopcock during continuous flushing, and then stayed in the stopcock after 5 minutes of continuous flushing.Further evaluation regarding related quality issues is under investigation.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 a part of the monthly review.

Event Description

It was reported that an unknown spot like material was found on the 120cm pressure tubing in an opened pouch before use.It is unknown whether the material was inside the pressure tubing or outside.Patient demographic information requested but unavailable.There were no patient complications reported.Per product evaluation findings, unknown clear material was observed inside pressure tubing.

Manufacturer Narrative

A device history record review was completed and documented that device met all specifications upon distribution.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 a part of the monthly review.

Manufacturer Narrative

A chemistry study was completed.The ir spectrum of the unknown clear material was consistent with that of polycarbonate, which is part of the manufacturing materials.The subject device component was sent to the third party manufacturer for evaluation.It was concluded that the contamination inside the product was not related to the third party process as the third party has no tool, equipment, container or any other material that could release a polycarbonate like material.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 a part of the monthly review.

• 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
• 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
• MDR Report Key: 15946434
• MDR Text Key: 306503920
• Report Number: 2015691-2022-09755
• 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: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/26/2023

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 Expiration Date: 05/24/2024
• Device Model Number: PXMK10649
• Device Lot Number: XK0057MT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/21/2022
• Initial Date FDA Received: 12/08/2022
• Supplement Dates Manufacturer Received: 12/15/2022; 01/05/2023
• Supplement Dates FDA Received: 12/22/2022; 01/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2022
• 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