MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS OXIMETRY CENTRAL VENOUS CATHETER

Model Number	X3820SJD
Medical Device Problem Code	Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product has been requested for return for a product evaluation.It has not arrived.Once the product evaluation has been completed a supplemental report will be submitted with the findings.The lot number is unknown.Therefore, the device history record review cannot be completed.Additional product codes, dre and dqe.Additional 510k number k110167.
Event or Problem Description
It was reported that there was a malfunction with the oximetry central venous catheter, during use.There was leakage from the optical module connector of the catheter.This resulted in medication loss of potassium.There was no patient injury.
Additional Manufacturer Narrative
The device was returned and a product evaluation was performed.The findings found that the report of leakage was confirmed.There was blood visible at the optical module connector.The leakage was detected between the distal lumen and the optical fiber lumen inside the backform.There was no leakage or occlusion observed in the proximal and medial lumens.A visual inspection found no other damage or inconsistency from the catheter, including at the tip.The backform was cut down and a gap was observed inside the backform between the distal lumen and optical fiber lumen.An engineering evaluation was initiated to assess for any manufacturing related processes which could be correlated to the complaint.Corrective action was generated to investigate leakage in the backform.There are process controls in place to detect the reported condition.100 percent tests are in place to identify the defect before the product is distributed.Based on the product investigation there is no evidence that the failure is related to a manufacturing defect.All devices passed their associated testing before distribution.A fundamental root cause was not able to be determined.Opportunities of process enhancement were identified to strengthen the manufacturing process.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 part of this monthly review.

• Brand Name: EDWARDS OXIMETRY CENTRAL VENOUS CATHETER
• Common Device Name: EDWARDS OXIMETRY CENTRAL VENOUS CATHETER
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES PR; state rd indus pk km 1.4; anasco PR 00610
• Manufacturer Contact: jonathan diaz ; 1 edwards way; irvine, CA 92614 ; 9492507258
• MDR Report Key: 21096653
• Report Number: 2015691-2025-00123
• Device Sequence Number: 8775842
• Product Code: DXG
• UDI-Device Identifier: 00690103197587
• UDI-Public: (01)00690103197587
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K053609
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2025

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
• Operator of Device: Health Professional
• Device Model Number: X3820SJD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/26/2024
• Supplement Date Received by Manufacturer: 03/31/2025
• Initial Report FDA Received Date: 01/07/2025
• Supplement Report FDA Received Date: 04/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown