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

Model Number X3820ST

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/09/2020

Event Type  malfunction  

Manufacturer Narrative

The device evaluation is anticipated.However, the complaint cannot not be confirmed without the completion of a product evaluation.A supplemental report will be forthcoming with the evaluation results when received.A review of the manufacturing records indicated that the product met specifications upon release.

Event Description

It was reported that during use with a 56-year-old female patient, there was an unknown amount of propofol leakage noted at the blue optical module connector of the presep catheter.The device was change to another one to continue.There was no allegation of patient injury.The device was available for evaluation.

Manufacturer Narrative

It was later communicated that the device was discarded at the hospital and not available for examination.The device was not returned for evaluation; it was discarded at the hospital.Without return of the unit it is not possible to determine if some damage or defect existed on the unit that could have contributed to the event.Although serious complications are relatively uncommon, the physician is advised to consider the potential benefits in relation to the possible complications.It is common clinical practice to inspect all products before use.These products are used by highly trained clinicians, experienced in identifying and mitigating any hazards that arise during use.In addition, these devices are typically used in intensive care units or operating rooms, where patients are closely monitored.Medication not being delivered consistently could cause a deterioration in the patients condition and may necessitate additional interventions.It is unknown whether user or procedural factors contributed to the stated event.In this case, there were no patient complications noted.There was no evidence to confirm that the product failure is related to a manufacturing or 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 part of this monthly review.

• Brand Name: PRESEP CENTRAL VENOUS OXIMETRY SET
• Type of Device: CATHETER, OXIMETER, FIBER-OPTIC
• Manufacturer (Section D): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco PR 00610
• MDR Report Key: 11555602
• MDR Text Key: 252344088
• Report Number: 2015691-2021-02025
• Device Sequence Number: 1
• Product Code: DQE
• Combination Product (y/n): N
• PMA/PMN Number: K053609
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/03/2021
• Device Model Number: X3820ST
• Device Catalogue Number: X3820ST
• Device Lot Number: 62544388
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Weight: 62