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

Model Number XT248HS

Device Problem Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/12/2016

Event Type  malfunction  

Manufacturer Narrative

We received one pediasat catheter with the extension tubes cut off and not returned for examination.Examination of the pediasat catheter found the catheter body to be loose in the backform.The backform was x-sectioned opened and it appears the catheter tube was not placed deep enough in the backform to become bonded during the backform process.All the extension tubes were cut off prior to being returned to edwards.The extension tubes were not returned.Both thru-lumens were patent and did not leak.A review of the manufacturing records indicated that the product met specifications upon release.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint.

Event Description

It was reported that the catheter was placed in the right femoral vein and the catheter was found to be leaking throughout the surgery where the connector was glued.Follow-up with the anesthesiologist indicated that the leak occurred where the green "sleeve" goes over the white catheter somewhere under that joint.No lasting injury reported but had to transfuse more blood.An arrow 4 fr double lumen catheter was used and the procedure was completed successfully.No patient injury was reported.

• Brand Name: PRESEP CENTRAL VENOUS OXIMETRY SET
• Type of Device: CATHETER, OXIMETER, FIBEROPTIC
• 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: brian hurd-servin ; 1 edwards way; irvine, CA 92614 ; 9492506423
• MDR Report Key: 5651575
• MDR Text Key: 45342232
• Report Number: 2015691-2016-01578
• 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: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/13/2016
• Device Model Number: XT248HS
• Device Lot Number: 59907731
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/24/2014
• 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