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

Model Number MHD8

Device Problem Incorrect Measurement (1383)

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

Event Date 07/06/2023

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.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.

Event Description

As reported, during use in patient with this flotrac sensor, inaccurate cco of unknown values were obtained.The patient was not treated according to the incorrect values.There was no error message displayed.The problem was solved using a new device.There was no allegation of patient injury.Patient demographics unavailable.

Manufacturer Narrative

Based on the additional information provided by the sales representative, an error message was displayed during the procedure.Potential for death or serious injury is remote.When an error message is displayed, the clinician is alerted of a potential issue, and this will trigger the clinician to conduct routine trouble shooting.Therefore, this event is no longer considered reportable and this correction is being submitted.Nevertheless, the device was sent to our product evaluation laboratory for a full evaluation.Customer report of inaccurate values issue was unable to be confirmed.Both flotrac and disposable pressure transducer (dpt) sensors of flotrac unit zeroed and sensed pressure on ev1000 and pressure monitor.No error message was noticed on the monitors.Electrical testing showed that both input impedance and output impedance were within specifications.Zero-offset also met specification.However flush path of flotrac unit was found occluded with what appeared to be adhesive at bond joint between dpt and flotrac sensor housings.The flush device appeared to be in good condition, no visible defect was observed from poppet cap.The rest of the kit including iv and pressure tubing sets was able to be primed and flushed without any problem.

Event Description

As reported, during use in patient with this flotrac sensor, inaccurate continuous cardiac output (cco) of unknown values were obtained.The patient was not treated according to the incorrect values.The problem was solved using a new device.There was no allegation of patient injury.The device was available for evaluation.Later during investigation it was reported there was an error message displayed during the event.

• Brand Name: FLO TRAC 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: 17369558
• MDR Text Key: 319893247
• Report Number: 2015691-2023-14731
• 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
• Report Date: 09/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MHD8
• Device Catalogue Number: MHD8
• Device Lot Number: UNKNOWN
• 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: 08/24/2023
• 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