MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR FLOTRAC SENSOR WITH VAMP SYSTEM; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Model Number MHD6AZA

Device Problem Loose or Intermittent Connection (1371)

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

Event Type  malfunction  

Manufacturer Narrative

The report of loose connection between the zero stopcock and the tube, and saline leakage could not be confirmed because pressure tube was not returned.No visible damage was observed from the unit.Device was able to prime without any problem.Flush device functioned properly and no visible defect was observed.No leakage was found from the entire unit during leak test.All connections were checked, and the connections were tight.Further evaluation is under investigation.The lot number was not provided thus a device history record was not reviewed.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 a part of the monthly review.

Event Description

It was reported connection between the zero stopcock and the pressure tubing on a flotrac sensor got loosened easily and disconnected when the customer changed the patient's body position.Saline leakage was also observed during use.The customer commented the problem occurred even after fastening the connection tightly.There were no patient complications reported.Patient information was not shared and the event date is unknown.

Manufacturer Narrative

The report of loose connection between the zero stopcock and the tube, and saline leakage could not be confirmed because pressure tube was not returned.No visible damage was observed from the unit.Device was able to prime without any problem.Flush device functioned properly and no visible defect was observed.No leakage was found from the entire unit during leak test.All connections were checked, and the connections were tight.Further evaluation is under investigation.The lot number was not provided thus a device history record was not reviewed.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 a part of the monthly review.

Event Description

It was reported connection between the zero stopcock and the pressure tubing on a flotrac sensor got loosened easily and disconnected when the customer changed the patient's body position.Saline leakage was also observed during use.The customer commented the problem occurred even after fastening the connection tightly.There were no patient complications reported.Patient information was not shared and the event date is unknown.

Manufacturer Narrative

This event was reported in error.There was no allegation of pressure tube detachment upon customer report or product evaluation.This is not a reportable 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 a part of the monthly review.

• Brand Name: FLOTRAC SENSOR WITH VAMP SYSTEM
• Type of Device: TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR
• Manufacturer (Section D): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal
• Manufacturer (Section G): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 13518424
• MDR Text Key: 285742573
• Report Number: 2015691-2022-03931
• Device Sequence Number: 1
• Product Code: DRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043065
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: MHD6AZA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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