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

Model Number MHD8S

Device Problem False Reading From Device Non-Compliance (1228)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/31/2016

Event Type  malfunction  

Manufacturer Narrative

Received one flotrac sensor with attached pressure tubing set.A review of the manufacturing records indicated that the product met specification at the time of release.No visible damage was observed from the unit.The dpt did not zero nor sense pressure on the pressure monitor.Electrical testing showed that the output impedance was within specifications, but input impedance was out of specification.Damage was found on the input circuit of the sensor chip.No error message was shown on a vigileo monitor.The flotrac sensor zeroed and sensed pressure accurately on the vigileo monitor.There was no visible damage or inconsistency observed from the solder joints and connectors.

Event Description

It was reported that the systolic arterial pressure value shown on the nihon kohden patient monitor was below 50mmhg, while the expected value should have been over 100mmhg during use.The value and the waveform both matched and the waveform was displayed as overdamping.It is unknown if there were any error messages observed.There was no problem zeroing before use and no occlusion, kinks or leaks were observed on the line.It was further indicated that the clinician was going to remove the needle to make another insertion site, but the problem was resolved by exchanging the flotrac unit and the cable.The sample of the tracing was not available.The patient was not treated based on the inaccurate value and there were no patient complications reported.

• Brand Name: FLOTRAC SENSOR
• Type of Device: TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR
• 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. san cristobal ; DR
• Manufacturer Contact: brian hurd-servin ; 1 edwards way; irvine, CA 92614 ; 9492506423
• MDR Report Key: 5591792
• MDR Text Key: 44121110
• Report Number: 2015691-2016-01294
• Device Sequence Number: 1
• Product Code: DRS
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K152980
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/05/2017
• Device Model Number: MHD8S
• Device Lot Number: 60174229
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2016
• Date Manufacturer Received: 03/31/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2015
• 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