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

Model Number X3820SJD

Device Problem Fluid/Blood Leak (1250)

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

Event Date 01/17/2024

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 with the evaluation and device history results when received.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 dressing was found filled with potassium chloride due to leakage when potassium chloride was injected from one of the lumens of this oximetry central venous (cv) catheter on the first day of use.The catheter was removed and a new one was inserted after the issue was noted.No patient injury occurred and no additional treatment was required due to leakage.The customer flushed the catheter after the removal but no leakage issue seemed to be confirmed and they believe there is no device malfunction.There were no patient complications reported.

Manufacturer Narrative

Our product evaluation lab received one model x3820sjd catheter.The customer report of leakage issue was not able to be confirmed.No visible inconsistency was observed from returned catheter during visual examination.All thru-lumens were found to be patent and did not leak.It was able to attach returned suture loop and box clamp on catheter body without problem.An engineering evaluation was performed to assess for any manufacturing related processes which could be correlated to the complaint.No defect was found; therefore a product non-conformance or device failure could not be confirmed and there is no evidence that supports or confirms the failure mode is associated to a manufacturing/design defect.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.Corrections to the h6 codes type of investigations, investigation findings, and investigation conclusions were made.

• Brand Name: PRESEP - CENTRAL VENOUS OXIMETRY CATHETER 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; edwards lifesciences pr; anasco
• Manufacturer Contact: jonathan diaz ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 18602927
• MDR Text Key: 334733828
• Report Number: 2015691-2024-00651
• 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: Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/26/2024

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: X3820SJD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/17/2024
• Initial Date FDA Received: 01/29/2024
• Supplement Dates Manufacturer Received: 02/23/2024
• Supplement Dates FDA Received: 02/26/2024
• 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