MAUDE Adverse Event Report: DEPUY MITEK MITEK FMS DUO+ PUMP/SHAVER COMBO; FMS EQUIPMENT SYSTEMS

Catalog Number 284580

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

Patient Problem Extravasation (1842)

Event Date 09/02/2014

Event Type  Injury  

Event Description

It was reported by the sales rep the fill chamber filled up to the top of the bottle during a knee arthroscopy, inflating the patient's knee.The case was stopped to allow the fluid to be evacuated from the knee and a second fms duo+ unit was used to complete the case with no consequence to the patient.One fms duo+ unit will be returned for analysis by the customer.

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.Awaiting device return.

Manufacturer Narrative

The device was received, evaluated and repaired.Per service bulletins, the worn fingers on complete pressure adjusters were replaced with tip replacement kit to correct fill chamber fill up issue.Also replaced were worn left and right tension rocker arms and broken hinges on irrigation safety cover.The unit passed all diagnostic tests, functional tests, and is fully operational.The reported failure could be confirmed on the pump due to worn parts.Further, a review into the depuy mitek complaints system revealed (b)(4) non-reportable complaint for this unit in 2009 and 2010.This indicates the device is old and its failure could be attributed to wear and tear due to repeated use.At this point in time, no further action is warranted.However, depuy 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

It was reported by the sales rep that the fill chamber filled up from the saline bag to the top of the bottle during a knee arthroscopy, inflating the patient's knee.The case was stopped to allow the fluid to be evacuated from the knee.The surgeon did manual compressions of the area to force out the excessive fluid.The sales rep is not sure what other methods were utilized to reduce the patient's swelling as he left the room at this point.The procedure was not completed and the sales rep had no information regarding the rescheduling of the case.One fms duo+ unit will be returned for analysis by the customer.The sales rep reported that the patient's status was fine.

• Brand Name: MITEK FMS DUO+ PUMP/SHAVER COMBO
• Type of Device: FMS EQUIPMENT SYSTEMS
• 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: siri belur ; 325 paramount drive; quality department; raynham, MA 02767 ; 8003824682
• MDR Report Key: 4102862
• MDR Text Key: 4834655
• Report Number: 1221934-2014-00416
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K954465
• 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
• Report Date: 09/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 284580
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2014
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 09/02/2014
• Event Location: Hospital
• Date Report to Manufacturer: 09/02/2014
• Date Manufacturer Received: 09/02/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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): Required Intervention