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

Model Number MHD8S

Device Problem Particulates (1451)

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

Event Date 09/02/2014

Event Type  malfunction  

Event Description

It was reported that the dpt did not zero on the patient monitor before use.There were no patient complications reported.

Manufacturer Narrative

A review of the manufacturing records indicated that the product met specification at the time of release.One flotrac sensor was received for evaluation.The dpt did not zero nor sense pressure on the pressure monitor.Visual examination found that the dpt gel pad appeared damaged and broken pieces of the gel were observed inside the fluid path around the gel pad.The unit was flushed for 5 minutes and the pieces of the gel did not moved nor flushed out of the unit.The pieces of the gel pad are located on patient side of the unit.The electrical testing showed that both input and output impedance were unstable.After cutting and opening the housing and back plate, the dpt sensor chip was found corroded with what appeared to be salt like material with moisture.Priming solution which could have leaked from the fluid path to the sensor chip had created short condition between the solder joints.Multiple attempts to identify the leak path failed, most likely due to the occlusion of the salt crystallized material along the leak path.The flotrac sensor zeroed and sensed pressure accurately on the vigileo monitor.

• 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: lynn selawski ; 1 edwards way; irvine, CA 92614 ; 9497564386
• MDR Report Key: 4190228
• MDR Text Key: 15808163
• Report Number: 2015691-2014-02475
• Device Sequence Number: 1
• Product Code: DRS
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 09/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/25/2016
• Device Model Number: MHD8S
• Device Lot Number: 59719741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/02/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/26/2014
• 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