MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR PRESEP CENTRAL VENOUS OXIMETRY SET; PRESEP CATHETER

Model Number XT245HSJ

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/07/2015

Event Type  malfunction  

Manufacturer Narrative

One double lumen pediasat catheter was returned for evaluation.As received, the catheter tube was cut and the distal side of the catheter was not returned.Dry blood was observed around the optic module connector.Leak testing confirmed an interlumen leakage in the backform between the distal and optic lumens.No leakage or occlusion was observed in the proximal lumen.Further examination found the catheter to be cut (clean sharp edges) 2.5cm distal of the backform.The distal section of the catheter tip was not returned.An x-ray of the backform was taken which confirmed a void inside the backform.Visual examinations were performed under microscope at 10x magnification.The lot number was not provided; therefore, a review of the manufacturing records could not be completed.Customer report of leakage issue was confirmed.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint and implement any necessary corrective actions.

Event Description

It was reported that blood leakage was observed from the extension tube during use.There were no patient complications reported.

• Brand Name: PRESEP CENTRAL VENOUS OXIMETRY SET
• Type of Device: PRESEP CATHETER
• 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: lynn selawski ; 1 edwards way; irvine, CA 92614 ; 9492504386
• MDR Report Key: 5181954
• MDR Text Key: 29407982
• Report Number: 2015691-2015-02883
• Device Sequence Number: 1
• Product Code: DQE
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K053609
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/07/2015

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: XT245HSJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2015
• Initial Date Manufacturer Received: 09/07/2015
• Initial Date FDA Received: 10/27/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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