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

Model Number MHD8

Device Problems Fluid/Blood Leak (1250); Incorrect Measurement (1383)

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

Event Date 05/30/2022

Event Type  malfunction  

Event Description

As reported, during use in patient with this flotrac sensor, stroke volume variation (svv) values were inaccurate due to a leakage from the flotrac unit.The svv value displayed was 6% while the expected value was 15% according to the patient status.No error message or alarm was displayed.This value was not compared to any other source due the medical condition of the patient.The issue was solved by replacing the device with a new set.The patient was not treated according to the wrong values as they found discrepancy.There was no allegation of patient injury.The device was available for evaluation.

Manufacturer Narrative

The product is expected to be returned for analysis; however, it has not yet been received.Upon the return of the product a supplemental report will be sent with the investigation results.

Manufacturer Narrative

One flotrac sensor was received by our product evaluation laboratory for a full examination.The report of leakage issue was confirmed.Leakage was observed from bonding connection between flotrac and dpt housing of the flotrac unit.Electrical testing showed that both input impedance and output impedance for both flotrac and dpt sensors of the flotrac unit were within specifications.Zero-offset for both sensors also met specification.No other visible damage or abnormality was observed from returned unit.The manufacturing records were reviewed for the lot involved and there is no indication of a related nonconformance.All process parameters were met and inspections passed successfully.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.

Manufacturer Narrative

Based on further engineering investigation, it could be determined that the condition is manufacturing process related.Corrective actions were initiated in order to investigate the cause of the non-conformity and based on this, there is a lack of adhesive in the joint of the two dpt sensor housings of the flotrac unit, which is creating a channel causing the leakage.Corrective actions are being implemented to prevent recurrence of this type of complaint.Additionally, it was verified that there are controls and procedures in place to detect a leak during the manufacturing process.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: 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: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 14752217
• MDR Text Key: 303178121
• Report Number: 2015691-2022-06282
• Device Sequence Number: 1
• Product Code: DRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152980
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2023
• Device Model Number: MHD8
• Device Catalogue Number: MHD8
• Device Lot Number: 63972951
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2021
• 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
• Patient Age: 40 YR
• Patient Sex: Male
• Patient Weight: 65 KG