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 Low Blood Pressure/ Hypotension (1914)

Event Date 09/28/2023

Event Type  malfunction  

Manufacturer Narrative

The device is anticipated to be returned for evaluation but has not yet been received.A supplemental will be sent with the evaluation results.A device history record review was unable to be completed as the lot number is unknown.H3 other text: device not returned.

Event Description

It was reported that while using this x3820sjd device, blood mixed with medication leakage was observed from the proximal extension tube after a mitral valve replacement (mvr) procedure.The systolic blood pressure temporarily dropped from 100mmhg to 40mmhg due to medication leakage.However, the patient outcome recovered.The following additional treatments were performed due to blood and medication leakage: treatment to increase blood pressure (details unknown) and starting an iv line with pre-existing access catheter for hemodialysis.The central venous (cv) catheter was removed without a replacement.Leaked medications were catecholamine, noradrenaline, landiolol hydrochloride and nicorandil diluted with saline and glucose.The amount of blood leakage is unknown.There was no extension of hospitalization was required.

Manufacturer Narrative

One triple lumen oximetry catheter was returned for evaluation.Suture loop and box clamp were attached on catheter body at 13 to 15cm marker area.Non edwards injection ports were attached at lumen hubs.The customers report of leakage was observed from the proximal extension tube was confirmed.As received, the proximal extension tube was found cut, approximately 1mm in size, at approximately 97mm proximal from backform.Leakage was observed from the cut on proximal extension tube.Both the distal and medial lumens were found to be patent without any leakage or occlusion.An engineering evaluation was initiated to assess for any manufacturing related processes which could be correlated to the complaint.Based on the available information there is no evidence that supports or confirms the failure mode is associated to a manufacturing/design defect.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.Correction: updates to the h6 codes are as follows: type of investigation was changed to testing of actual suspected device.Investigation findings was changed to leakage seal.Investigation conclusions was changed to cause not established.

• 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 PR 00610
• Manufacturer (Section G): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• Manufacturer Contact: jonathan diaz ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 17965952
• MDR Text Key: 326314986
• Report Number: 2015691-2023-16909
• 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,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/13/2023

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 Operator: 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
• Initial Date Manufacturer Received: 09/28/2023
• Initial Date FDA Received: 10/19/2023
• Supplement Dates Manufacturer Received: 12/12/2023
• Supplement Dates FDA Received: 12/13/2023
• 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
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 53 KG