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

Model Number MHD8S

Device Problem Fluid/Blood Leak (1250)

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

Event Date 04/27/2022

Event Type  malfunction  

Event Description

It was reported that a heparinized saline leakage was observed at the time of priming before use.The exact location of the leakage is unknown.There were no patient complications reported.

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 and device history results when received.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.

Manufacturer Narrative

Heparinized saline is used per hospital protocol to maintain patency in the pressure line/catheter and in this case was not going to be used as a treatment for the patient.There was no loss of therapeutic medication, which in accordance with our decision rationale matrix does not meet the criteria for an mdr reportable event.A product evaluation was completed.The reported event of leakage was confirmed.As received, flotrac housing male luer had been completely broken.The broken luer was found to be jagged.Leakage was most likely due to broken luer.No leakage was found from rest of the unit during leak test.No other damage was observed from the kit.Per evaluation findings, device was confirmed for broken luer.This is not a reportable event.A device history record review was completed and documented that device met all specifications upon distribution.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.

Manufacturer Narrative

It was found within our procedure and decision rationale documentation that this event was reported in error.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
• 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: jonathan diaz ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 14438483
• MDR Text Key: 292071351
• Report Number: 2015691-2022-05759
• 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,Followup
• Report Date: 06/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 08/04/2023
• Device Model Number: MHD8S
• Device Lot Number: 63870514
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/04/2021
• 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