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

Model Number MHD6

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/08/2015

Event Type  malfunction  

Manufacturer Narrative

We received one flotrac kit for examination.Priming solution was visible inside of the kit.The flotrac sensor did not zero or sense pressure.Error message of "incompatible sensor" was noticed on the vigileo monitor.Electrical testing showed that input circuit was open and output impedance was out of specification.Electrical testing of the sensor chip suggested the defect was within the sensor.The solder joints of the flotrac sensor chip was also corroded.Leakage was detected from the flotrac housing fluid path across damaged sensor (gel) pad to the sensor chip.Gel material from damaged gel pad was noticed on the surface of the fluid path housing.The gel material remained attached to the surface of the fluid path housing during 5 minutes of continuous flushing.Leakage of priming solution had corroded the solder joints of the flotrac sensor chip.The dpt sensor of the flotrac unit zeroed and sensed pressure accurately on a vigileo monitor.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint.A supplemental report will be forthcoming with the device history results once received.

Event Description

It was reported that during use the sensor was faulty and the error message "incompatible sensor" was displayed on the monitor.There were no patient complications reported.

Manufacturer Narrative

A review of the manufacturing records indicated that the product met specifications upon release.

• 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; haina, san cristobal ; DR
• Manufacturer Contact: lynn selawski ; 1 edwards way; irvine, CA 92614 ; 9497564386
• MDR Report Key: 5064376
• MDR Text Key: 25273926
• Report Number: 2015691-2015-02343
• Device Sequence Number: 1
• Product Code: DRS
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K043065
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 07/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/10/2017
• Device Model Number: MHD6
• Device Lot Number: 59966212
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/06/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/11/2015
• 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