MAUDE Adverse Event Report: DEPUY MITEK MITEK FMS VUE FLUID MANAGEMENT SYSTEM

Catalog Number 284002

Device Problems Unknown (for use when the device problem is not known) (2204); Improper Flow or Infusion (2954)

Patient Problems Extravasation (1842); Swelling (2091)

Event Date 06/26/2015

Event Type  Injury  

Event Description

During surgery (already 30 min on the way) the chamber of the inflow system was filled more and more with nacl.The pump was working very very hard, full speed.The pressure in the shoulder got up within 15 minutes and made the shoulder very swollen.Water even came out of the cannulas.Shoulder was very swollen, which made finishing the procedure very hard.Disconnected tubings and put new ones back on, delay was 30 minutes.See associated medwatch # 1221934-2015-00879.

Manufacturer Narrative

Attempts have been made to retrieve additional information about the event and device.The additional information will reportedly be forwarded to depuy synthes mitek however it is not known if it will be received within the 30 day reporting requirement, therefore depuy synthes 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.Other text : in transit.

Manufacturer Narrative

The complaint device has not been returned, therefore is unavailable for a physical evaluation.Further, no serial number of the complaint device pump was reported, so a review into the depuy synthes mitek complaints system for similar complaints with this device is not possible.We cannot discern a root cause for the reported failure mode; however the likely root cause is the tube set used with the pump, which was returned and tested.The test of the tube set confirmed the complaint event.At this point in time, no corrective action is required and no further action is warranted.However, depuy synthes 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.Should the complaint device pump ever be returned at some point in the future, this complaint file will be reopened at that time and an evaluation will be performed and documented.

Event Description

During surgery (already 30 min on the way) the chamber of the inflow system was filled more and more with nacl.The pump was working very very hard, full speed.The pressure in the shoulder got up within 1.5 minutes and made the shoulder very swollen.Water even came out of the cannulas.Shoulder was very swollen, which made finishing the procedure very hard.Disconnected tubings and put new ones back on, delay was 30 minutes.See associated medwatch # 1221934-2015-00879.

• Brand Name: MITEK FMS VUE FLUID MANAGEMENT SYSTEM
• Type of Device: FLUID MANAGEMENT SYSTEM
• 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: david primmerman ; 325 paramount drive; quality department; raynham, MA 02767 ; 8003824682
• MDR Report Key: 4938290
• MDR Text Key: 6255134
• Report Number: 1221934-2015-00878
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K130169
• 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: 06/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 284002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 06/26/2015
• Event Location: Hospital
• Date Report to Manufacturer: 06/26/2015
• Date Manufacturer Received: 06/26/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other