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

Model Number X3820S

Device Problem Detachment Of Device Component (1104)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 10/20/2016

Event Type  malfunction  

Manufacturer Narrative

We received one triple lumen 20cm presep catheter with 2 - non edwards stopcocks for examination.No packaging was returned.The reported event of "detached from connection" was not confirmed.The catheter passed in-vitro calibration and all through lumens were patent and did not leak.The returned non edwards stopcocks were found to fit tight to all 3 of the catheter hub's.The catheter body was found to be in good condition, there are no kinks or indentations.The suture loop and box clamp were also in good condition.The reported event was not confirmed.Although the cause of the complaint could not be determined, there was no indication of a manufacturing defect noted during the analysis.A review of the manufacturing records indicated that the product met specifications upon release.It is standard clinical practice to check and tighten all connections prior to and during use of the product.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 part of this monthly review.No corrective or preventative actions are required at this time.

Event Description

It was reported that the presep catheter slowly detached from the connection and the patient experienced a hypotensive episode while the catheter was being replaced.Attempts have been made for additional information but have not successful at this time.Inquired of patient demographics.Unable to be obtained.

Manufacturer Narrative

No product was returned for the reported event.Upon obtaining additional information it was discovered the evaluation previously submitted was not meant for this complaint and submitted in error.The lot number is unknown for this event.

Manufacturer Narrative

The lot number was able to obtained and verified.A review of the manufacturing records indicated that the product met specifications upon release.

• Brand Name: PRESEP CENTRAL VENOUS OXIMETRY KIT
• 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: 6122967
• MDR Text Key: 60762258
• Report Number: 2015691-2016-03475
• Device Sequence Number: 1
• Product Code: DQE
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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,Followup,Followup
• Report Date: 11/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/12/2018
• Device Model Number: X3820S
• Device Lot Number: 60375411
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 11/08/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/03/2016
• Initial Date FDA Received: 11/22/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/18/2016; 02/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/17/2016
• 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 Outcome(s): Other