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

Model Number X3820SJD

Device Problem Fluid/Blood Leak (1250)

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 with the evaluation when received.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 high calorie solution leaked from an oximetry cv catheter during use.The location of leakage was unable to be confirmed since the bed sheet was found soaked when the hospital staff noticed the leakage.The catheter was removed after the issue was noted.No patient injury occurred and no additional treatment was required due to leakage.It was unable to obtain information regarding what kind of surgery or examination the catheter was used for.Patient demographic information was requested but unavailable.

Manufacturer Narrative

A product evaluation was completed.The reported event 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.An engineering evaluation was initiated to assess for any manufacturing related processes which could be correlated to the complaint.The complaint for catheter body leakage was unable to be confirmed through product evaluation since the affected unit was returned for evaluation and no defect was found.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: 18620014
• MDR Text Key: 334369716
• Report Number: 2015691-2024-00699
• 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: 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 Model Number: X3820SJD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/18/2024
• Initial Date FDA Received: 01/31/2024
• Supplement Dates Manufacturer Received: 02/21/2024
• 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