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

Model Number FLOTRACUNKNOWN

Device Problems Display or Visual Feedback Problem (1184); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 05/30/2019

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for evaluation; it was discarded at the hospital.Without return of the unit it is not possible to determine if some damage or defect existed on the unit that could have contributed to the event.It is not known if some procedural factors may have contributed to the event.No corrective actions will be taken at this time.Lot number was not provided; therefore review of the manufacturing records could not be completed.Poor dynamic response can be caused by air bubbles, clotting, and excessive lengths of tubing, excessively compliant pressure tubing, small bore tubing, loose connections, or leaks.The assembly may be tested for dynamic response by observing the pressure waveform on an oscilloscope or monitor.Bedside determination of the dynamic response of the catheter, monitor, kit and transducer system is done after the system is flushed, attached to the patient, zeroed and calibrated.A square-wave test may be performed by pulling the snap tab device and releasing quickly.Pressure readings can change quickly and dramatically because of loss of proper calibration, loose connection, or air in the system.Pressure readings should correlate with the patient¿s clinical manifestations.In this event, there was no patient compromise noted.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

It was reported that there were inaccurate values displayed with the flotrac sensor during patient monitoring.There is a flotrac cable and ev1000a platform system that were being used that could not be ruled out as suspect.The anesthesiologist stated the inaccurate values had occurred two previous times within the past couple of weeks.The transesophageal echocardiogram (tee) reading was lower than the flotrac reading for stroke volume (sv).The sv reading on the tee was 30¿s to 40¿s and the flotrac reading was 70¿s to 80¿s.The doctor believed that the patient was under resuscitated and he used the tee reading for volume optimization.Exact occurrence dates are unknown.The events with the flotrac cable and ev1000 system will be submitted via mdrs.The two similar events with the flotrac sensor will be submitted via mdr¿s.There was no inappropriate patient treatment administered.There was no harm or injury to the patient.The patient demographic information is not available.The flotrac was discarded at the hospital.

Manufacturer Narrative

Please refer to the following submission numbers representing the events and products involved: ev1000a platform system 2015691-2019-02286 first occurrence ev1000a platform system 2015691-2019-02287 second occurrence ev1000a platform system 2015691-2019-02288 third occurrence evftcl flotrac cable 2015691-2019-02289 first occurrence evftcl flotrac cable 2015691-2019-02290 second occurrence evftcl flotrac cable 2015691-2019-02291 third occurrence flotrac sensor 2015691-2019-02299 first occurrence flotrac sensor 2015691-2019-02300 second occurrence flotrac sensor 2015691-2019-02298 third occurrence.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

• Brand Name: UNKNOWN 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 ; DR
• MDR Report Key: 8725182
• MDR Text Key: 151031120
• Report Number: 2015691-2019-02298
• Device Sequence Number: 1
• Product Code: DRS
• Combination Product (y/n): N
• PMA/PMN Number: K043065
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 05/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FLOTRACUNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1