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

Model Number MHD8S

Device Problem Improper Flow or Infusion (2954)

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

Event Date 01/16/2014

Event Type  malfunction  

Manufacturer Narrative

Received one flotrac kit for evaluation.Examination revealed priming solution was visible inside the kit.The flush device functioned properly during priming and flushing.The flush device opened for fluid passage when activated and completely closed fluid passage when inactivated.No visible defect or damage was observed from the flush device.The poppet was seated straight inside the housing and making complete contact with the housing cap.The cap was also welded straight and flat to the flush device housing.Red dye solution was manually introduced through the fluid path (flow restrictor) without activating the flush device.A visual inspection of the flush device showed that there was no leakage across the poppet when it was at closed position.The flow rate testing also indicated that the flow rate, 2.8ml/hour, was also within specification.No leakage was observed from the kit during the priming.

Event Description

It was reported that the pull tab did not return back to its original position after being pulled and the saline continued to flow during priming before use.It is unknown how much pressure was applied to the saline bag.There were no patient complications reported.

Manufacturer Narrative

The device evaluation is anticipated.However, at this time the complaint could not be confirmed without the product.A review of the manufacturing records indicated that the product met specification at the time of release.A supplemental report will be sent with the final investigation results.

Manufacturer Narrative

Base on the fact that reported defect was not confirmed.(b)(4).

• 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: selawski ; 1 edwards way; irvine, CA 92614 ; 9497564386
• MDR Report Key: 4512858
• MDR Text Key: 17376925
• Report Number: 2015691-2015-00295
• 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,Followup,Followup
• Report Date: 01/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MHD8S
• Device Lot Number: 59888326
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/16/2014
• 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