MAUDE Adverse Event Report: DEPUY MITEK MITEK FMS DUO + PUMP/SHAVER COMBO; FLUID MANAGEMENT SYSTEM

Catalog Number 284580

Device Problem Insufficient Information (3190)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/03/2015

Event Type  Injury  

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.

Event Description

It was reported by the sales rep that the pump is broken.It was unknown how the procedure was completed.No patient consequence.Device will be returned and replaced pending additional information.The following additional information was received via email from our sales rep on (b)(6) 2015; the procedure was extended over thirty minutes due to the issues with the fms pump.

Manufacturer Narrative

Multiple attempts have been made to retrieve the device, however the complaint device has not been returned, therefore is unavailable for a physical evaluation.We cannot discern a root cause for the reported failure mode, however the device is approximately nine years old and a possible root cause could be fair wear and tear.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 ever be received back in the future, this file will be reopened at that time and an evaluation will be performed and documented.

• Brand Name: MITEK FMS DUO + PUMP/SHAVER COMBO
• 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: 5048119
• MDR Text Key: 24757705
• Report Number: 1221934-2015-00953
• 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: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Report Date: 08/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 08/03/2015
• Device Age: 9 YR
• Event Location: Hospital
• Date Report to Manufacturer: 08/03/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/01/2015
• 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): Required Intervention