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

Catalog Number 284508

Device Problems Unknown (for use when the device problem is not known) (2204); Improper Flow or Infusion (2954); Pressure Problem (3012)

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 # 1221934-2015-00878.

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

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

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 # 1221934-2015-00878.

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.Device evaluated by mfr: in transit.

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 1,5minutes 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 # 1221934-2015-00878.

Manufacturer Narrative

The complaint tube set was received at mitek and taken to the lab for evaluation.Visual inspection under magnification revealed the tube set appeared in a used condition, there was fluid inside of the tubing.The tube set did not show any obvious signs of visual damage.The tube set was connected to an fms vue pump and the spikes were placed in a container of water.When the pump was turned on and the fill chamber button was pressed the fill chamber started to fill and continued to fill after the fill chamber button on the pump was not being pressed anymore.This complaint can be confirmed.Upon further inspection it was noticed that there was fluid in the tube set area near the filter.One of the potential causes of this type of failure could be that the filter got wet; a wet filter would cause this type of failure.A batch record review has been conducted to determine if there were any internal processing issues which would have contributed to the nature of the product complaint.Our 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 synthes mitek complaints system revealed only one other similar complaint and one other dissimilar complaint for this lot of (b)(4) devices that were released to distribution.The complaint rate was reviewed against the risk analysis and found to be within the expected outcome.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.

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 # 1221934-2015-00878.

• Brand Name: MITEK FMS VUE FLUID MANAGEMENT SYSTEM INFLOW TUBING
• Type of Device: FLUID MANAGEMENT SYSTEM INFLOW 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: david primmerman ; 325 paramount drive; quality department; raynham, MA 02767 ; 8003824682
• MDR Report Key: 4938338
• MDR Text Key: 19638628
• Report Number: 1221934-2015-00879
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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,Followup
• 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 Expiration Date: 03/31/2016
• Device Catalogue Number: 284508
• Device Lot Number: D407905
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2015
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 06/26/2015
• Device Age: 14 MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/26/2015
• Date Manufacturer Received: 06/26/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/22/2014
• 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
• Patient Outcome(s): Other