MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR FLOTRAC SENSOR; TRANSDUCER, PRESSURE, SINGLE USE

Model Number MHD8R5

Device Problem Incorrect Measurement (1383)

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

Event Date 10/27/2021

Event Type  malfunction  

Manufacturer Narrative

The lot number for this device was not supplied: therefore, further review of the related manufacturing records could not be performed.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.

Event Description

As reported, when starting monitoring in cardiosurgical icu after mitral and aortic valve replacement, this flotrac sensor displayed inaccurate hemodynamic parameters (medwatch 09232).The incorrect values confirmed by echo were: arterial blood pressure 123/42mmhg (60); cardiac output: 11,2 l/min; stroke volume: 125 ml/b and systemic vascular resistance index 582dyne-s-m2/cm3.There was no error message displayed.Flotrac sensor (medwatch 09368) and hemosphere monitor were replaced without success.Then, monitoring was done by regular echo checking.The patient was not medicated or treated according to the inaccurate parameters.There was no allegation of patient injury.The first flotrac sensor was available for evaluation.The second flotrac sensor was discarded.It was specified that the hemosphere monitoring platform is working fine and is still in use at the hospital site.

Manufacturer Narrative

We were further informed that this device was not available for examination since it was discarded at hospital site.Without return of the product, edwards is unable to perform a complete investigation of the reported event.It is not possible to determine what factors may have contributed to it, and therefore no actions could be planned.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint.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

Three pictures were provided for investigation and were examined.The hemodynamic values reported were confirmed.However, the device malfunction could not be assessed.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, PRESSURE, SINGLE USE
• Manufacturer (Section D): 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: 12826095
• MDR Text Key: 284972130
• Report Number: 2015691-2021-06333
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183413
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MHD8R5
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/27/2021
• Initial Date FDA Received: 11/17/2021
• Supplement Dates Manufacturer Received: 11/18/2021; 12/23/2021
• Supplement Dates FDA Received: 12/01/2021; 12/28/2021
• 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: 30 YR
• Patient Sex: Male