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

Model Number MHD6R

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/03/2016

Event Type  malfunction  

Manufacturer Narrative

The device evaluation is anticipated.However the complaint could not be confirmed without the completion of the product evaluation.A supplemental report will be forthcoming with the evaluation results.Lot number was not provided, therefore, review of the manufacturing records could not be completed.

Event Description

As reported, during use of this flotrac sensor, high blood pressure value was displayed on the monitor that did not correlate with the blood pressure value taken with arm cuff (nibp).It was specified that no particular alarm was displayed on the monitor.The arterial waveform displayed on the monitor was pai (invasive arterial pressure) 160/70 at right radial.The patient was treated based on high blood pressure value.But 30 minutes later verification was done by taking blood pressure using an arm cuff with a result of 80/40 in the left arm.So hemodynamic strategy was immediately changed to antihypertensive (norepinephrine).After that the flotrac, monitor and line were changed and there was no further anomaly in pai.Device was available for evaluation.

Manufacturer Narrative

We received one flotrac kit for examination.Priming solution was visible inside of the kit.Both the flotrac and dpt sensors zeroed and sensed pressure accurately on the vigileo and pressure monitor.The pressure readings from both sensors were stable during the pressure drift test.Electrical testing showed that the flotrac input and output impedances were within specifications.Zero-offset also met specification per the ifu.No leakage or occlusion was detected from the kit during the pressure test.No visible defect was observed from the kit.The reported event was not confirmed.Although the cause of the complaint could not be determined, there was no indication of a manufacturing defect noted during the analysis.No actions will be taken at this time.

• 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
• Manufacturer (Section G): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; DR
• Manufacturer Contact: brian hurd-servin ; 1 edwards way; irvine, CA 92614 ; 9497566423
• MDR Report Key: 5461822
• MDR Text Key: 39085578
• Report Number: 2015691-2016-00564
• Device Sequence Number: 1
• Product Code: DRS
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K043065
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MHD6R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/29/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/02/2016
• 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