MAUDE Adverse Event Report: EDWARDS LIFESCIENCES PR PRESEP CENTRAL VENOUS OXIMETRY KIT; CATHETER, OXIMETER, FIBER OPTIC

Model Number X3820SJD

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Type  malfunction  

Manufacturer Narrative

The device evaluation is anticipated.However, the complaint cannot be confirmed without the completion of a product evaluation.A supplemental report will be forthcoming when the investigation is completed.The lot number was not provided thus a device history record was not reviewed.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 the optical module connector, while still connected to the patient got detached from the extension tube during use and scvo2 values were still displayed.There were no patient injuries.Catheter was not replaced when issue occurred.Rep was unsure of the surgery or examination the catheter was used for and if other specific values were observed.Patient demographic information was requested but unavailable.Sales rep noticed that that the catheter tip was found cut near medial lumen port when the product was returned.Detailed information including whether the customer cut the catheter or when the catheter was cut could not be obtained.

Manufacturer Narrative

A product evaluation was completed.The reported event of optical module connector got detached from the extension tube was confirmed.As received, optical extension tube was detached from optical module connector, and fibers were exposed.Residual adhesive was observed at bond area of the detached part.Proximal and medial lumens were found to be patent and did not leak.No leakage was also confirmed on distal lumen from hub.An engineering evaluation was initiated to assess for any manufacturing related processes which could be correlated to the complaint.Based on the available information, the failure of optic system, detached from connector cannot be confirmed as a manufacturing or design error.The failure can be related to multiple root causes that are not able to be determined.Corrections to the h6 codes type of investigations, investigation findings, and investigation conclusions were made.

• Brand Name: PRESEP CENTRAL VENOUS OXIMETRY KIT
• Type of Device: CATHETER, OXIMETER, FIBER OPTIC
• Manufacturer (Section D): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco
• Manufacturer (Section G): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco
• Manufacturer Contact: jonathan diaz ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 18632317
• MDR Text Key: 334444458
• Report Number: 2015691-2024-00756
• Device Sequence Number: 1
• Product Code: DQE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K053609
• 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: 03/19/2024

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 Model Number: X3820SJD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/26/2024
• Initial Date FDA Received: 02/02/2024
• Supplement Dates Manufacturer Received: 03/15/2024
• Supplement Dates FDA Received: 03/19/2024
• 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