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 Problem Unknown (for use when the device problem is not known) (2204)

Patient Problems Extravasation (1842); Surgical procedure, delayed (2565)

Event Date 02/05/2015

Event Type  Injury  

Event Description

No aspiration by the "arthropompe".Interruption of the procedure several minutes.Saline accumulation in the articulation.Call the biomedical to see the dysfunction.Consumption more than double the material.Additional information: - the extension of greater than 30 minutes is known since, (b)(6) 2015.

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.

Manufacturer Narrative

The device that was received was not the actual device that failed during the surgery.The hospital returned the same product code tube set as the complaint device from their inventory to be evaluated, however the lot number of the complaint device could not be confirmed by the customer.Visual observation does not indicate any anomalies on the device.The tube set was tested.The vented spikes were placed in a container of water.The tube set was connected to the fms duo pump and the blue luer-lock was placed in a container to catch the water pumped through the tube set.The pump was turned on, the fill chamber primed and the pump ran until all of the water in the container was pumped through the tube set.The tube set functioned as intended.No leak below fill chamber or on the luer-lock joint was observed.Therefore, the reported failure cannot be confirmed.A possible root cause might be that the luer-lock was not tightened properly, resulting in a leak in the pressure sensing line for the pump.A batch review was not conducted as the batch number of the actual complaint device is unknown.No corrective action is required and no further action is warranted at this time.However, mitek 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.Interruption of the procedure several minutes.Saline accumulation in the articulation.Call the biomedical to see the dysfunction.Consumption more than double the material.Additional information: the extension of greater than 30 minutes is known since today, (b)(6) 2015.

Manufacturer Narrative

Attempts have been made to retrieve additional information about the event and device.The additional information will reportedly be forwarded to depuy (b)(4) however it is not known if it will be received within the 30 day reporting requirement, therefore depuy (b)(4) 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.

Event Description

No aspiration by the arthropompe.Interruption of the procedure several minutes.Saline accumulation in the articulation.Call the biomedical to see the dysfunction.Consumption more than double the material.Additional information - the extension of greater than 30 minutes is known since, (b)(6) 2015.

• 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: 4773347
• MDR Text Key: 19811407
• Report Number: 1221934-2015-00784
• 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: Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 284649
• 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
• Event Location: Hospital
• Date Report to Manufacturer: 03/20/2015
• Date Manufacturer Received: 03/20/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other