MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR DISPOSABLE PRESSURE TRANSDUCER; FLOTRAC SENSOR

Model Number MHD6R

Device Problem High Readings (2459)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/11/2014

Event Type  malfunction  

Manufacturer Narrative

One flotrac kit was received for evaluation.The examination revealed that the flotrac and dpt sensors performed zeroing and sensed pressure accurately on both a vigileo monitor and a pressure monitor.There was no error message observed.The pressure readings were stable from both flotrac and dpt sensors.They did not drift during the pressure drift test.The electrical testing showed that both the input and output impedances were within specifications.There was no leakage detected during the pressure test and there was no visible damage found from the flotrac kit.The lot number was not provided; therefore, a review of the manufacturing records could not be completed.The complaint could not be confirmed during evaluation.There is no indication of a manufacturing defect that was noted during the analysis.It could not be determined if any clinical or procedural factors may have contributed to the event.No actions will be taken at this time.

Event Description

As reported the flotrac device measured high values of systolic volume that did not correlate with a doppler echocardiography.The clinicians tried another vigileo monitor and the same high values appeared.A square wave test was performed and it was underdamped.There was no error message or alarm that advised that the values were inaccurate.The patient was not treated according to the inaccurate values, current status of the patient is good.

• Brand Name: DISPOSABLE PRESSURE TRANSDUCER
• Type of Device: FLOTRAC SENSOR
• Manufacturer (Section D): EDWARDS LIFESCIENCES DR; carretera sanchez, km 18 1/2; parque ind. de itabo; haina, san cristobal ; DR
• Manufacturer (Section G): EDWARDS LIFESCIENCES DR; carretera sanchez, km 18 1/2; parque ind. de itabo; haina, sana cristobal ; DR
• Manufacturer Contact: lynn selawski ; 1 edwards way; irvine, CA 92614 ; 9497564386
• MDR Report Key: 3722106
• MDR Text Key: 16287896
• Report Number: 2015691-2014-00756
• Device Sequence Number: 1
• Product Code: DRS
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K043065
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MHD6R
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/27/2014
• 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