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

Model Number XT245SJ

Device Problem Leak/Splash (1354)

Patient Problem Congenital Defect/Deformity (1782)

Event Date 08/07/2017

Event Type  malfunction  

Manufacturer Narrative

The device evaluation is in progress.A supplemental report will be sent with the investigation results.The lot number was not provided; therefore, a review of the manufacturing records could not be completed.

Event Description

It was reported that blood leakage was observed from the pediasat oximetry catheter on the second day of use.The patient was a 10 month old male having surgery for hypoplastic left heart syndrome.Leakage was not observed during surgery or on the day after the surgery; however, blood leakage was confirmed on the following day.It appeared that the optical module line had detached from the catheter leading to leakage and the optical fiber was exposed.The catheter was immediately clamped and the leakage was stopped.The catheter was removed from the patient.Treatments such as blood infusion were not necessary, and there were no patient complications reported.Other patient demographic information requested but unavailable.

Manufacturer Narrative

One extension tube of the pediasat catheter was returned for evaluation.The catheter body or other components were not returned.As received, the optical extension tube was detached from the optical module connector.Residual adhesive was observed at bond area of the detached extension tube.Actual length of the returned extension tube was measured to be approximately 15.9".The length of the fiber extension tube should measure 31.3+/-1.0".Visual inspection confirmed that the returned extension tube was cut in half.The distal side of the optical extension tube was not returned for evaluation.The cross surface of the proximal end, where the optical module connector should be assembled was smooth, but the distal end where the extension tube had been cut was found to be rough and uneven.The optical module connector was opened and the fibers inside the connector were found to be uncoiled.No trace of blood leakage was observed in the optical module connector.Visual examinations were performed under microscope at 10x magnification.Customer report of issue with optical module line was confirmed.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint and implement.Invasive procedures involve some patient risks.Although serious complications are relatively uncommon, the physician is advised, before deciding to insert or use the catheter, to consider the potential benefits in relation to the possible complications.The techniques for insertion, methods of using the catheter to obtain patient data information, and the occurrence of complications is well described in the literature.In this case, blood leakage occurred in a pediatric patient, who would have a lower threshold for brief interruptions in therapy or minor amounts of bleeding than an adult patient.This results in a higher potential for an injury to occur.It is unknown whether user or procedural factors contributed to the stated event.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.

• Brand Name: PRESEP CENTRAL VENOUS OXIMETRY SET
• Type of Device: PRESEP CENTRAL VENOUS OXIMETRY SET
• 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 ; 9497564386
• MDR Report Key: 6852738
• MDR Text Key: 85444786
• Report Number: 2015691-2017-02839
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 08/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: XT245SJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/11/2017
• 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
• Patient Age: 10 MO