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

Model Number MHD8S

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/20/2018

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.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 a 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.There was no patient compromise noted in this event.It is unknown whether user or procedural factors played a role in this 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 part of this monthly review.

Event Description

It was reported, that in a female patient with a peritoneal tumor, the cardiac index (ci) and stroke volume (sv) indicated on the monitor was inaccurate during use.Although the customer expected ci 2.0 l/min/m2 and sv 60ml, the actual value indicated on the monitor was ci 0.6 and sv 20 respectively.No error messages were noted.The pressure value indicated on the patient monitor (nihon kohden­) was accurate.There was no problem with the shape of the pressure waveform and zeroing before use.The customer tried to see fluid responsiveness but the values did not change on the monitor.The customer did not exchange the kit nor perform other trouble shooting methods.There were no patient complications reported.The device was discarded by the hospital.

Manufacturer Narrative

The referenced medwatch number are: 2015691-2018-02925 for the vigileo monitor and 2015691-2018-02927 for the apco9 cable.

Manufacturer Narrative

Corrected data: f10, h6.Reference (b)(4).

• 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 ; DR
• MDR Report Key: 7700179
• MDR Text Key: 114808588
• Report Number: 2015691-2018-02902
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 06/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MHD8S
• 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