MAUDE Adverse Event Report: DEPUY MITEK FMS FLUID MANAGEMENT SYSTEM OUTFLOW TUBING W/ONE-WAY VALVE (FMS VUE OR FMS DUO); FMS TUBING

Catalog Number 284649

Device Problems Suction Problem (2170); Unknown (for use when the device problem is not known) (2204)

Patient Problem Extravasation (1842)

Event Date 02/09/2015

Event Type  Injury  

Event Description

No aspiration by the arthropompe.Momentary interruption of the procedure.Saline accumulation in the articulation.Call the biomedical to see the dysfunction.Consumption more than double the material.

Manufacturer Narrative

Attempts have been made to retrieve additional information about the event and device.The additional information will reportedly be forwarded to depuy mitek however it is not known if it will be received within the 30 day reporting requirement, therefore depuy mitek would like to file this initial medwatch report at this time.When and if additional information is received it will be reflected in a follow-up medwatch report.Awaiting return of the device.

Manufacturer Narrative

The products were received and inspected visually.Visual observation reveals no anomalies on the devices.The tube sets were attached to an fms duo pump.The spikes were placed in a container of water, the fill chamber was primed and the device functioned as intended.The tube sets were then pinched to simulate the pump reaching the required pressure and the pump head roller assembly slowed down as intended.When released the pump head started to spin faster.One liter of water was pumped through the tube sets and they functioned as intended.The functional and visual tests for both tube sets revealed no anomalies.This complaint cannot be confirmed.A batch record review has been conducted for this lot of devices that were manufactured and the results indicate that this batch of product was processed without incident and therefore there is no internally assignable cause for the reported problem.Further, a review into the depuy (b)(4) complaints system revealed two dis-similar complaints for the batch number of this device.Based on the overall complaint rate and customer impact, at this point in time, no further action is warranted.However, depuy (b)(4) will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.

Event Description

No aspiration by the arthropompe.Momentary interruption of the procedure.Saline accumulation in the articulation.Call the biomedical to see the dysfunction.Consumption more than double the material.

• Brand Name: FMS FLUID MANAGEMENT SYSTEM OUTFLOW TUBING W/ONE-WAY VALVE (FMS VUE OR FMS DUO)
• Type of Device: FMS TUBING
• Manufacturer (Section D): DEPUY MITEK; 325 paramount drive; quality department; raynham MA 02767
• Manufacturer (Section G): DEPUY MITEK; 325 paramount drive; na; raynham MA 02767
• Manufacturer Contact: eric so ; 325 paramount drive; quality department; raynham, MA 02767 ; 8003824682
• MDR Report Key: 4775122
• MDR Text Key: 18092079
• Report Number: 1221934-2015-00785
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K951843
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative,Distributor,company repres
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2016
• Device Catalogue Number: 284649
• Device Lot Number: D414125
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2015
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/20/2015
• Device Age: 10 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/20/2015
• Date Manufacturer Received: 03/20/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/14/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other