MAUDE Adverse Event Report: DEPUY MITEK MITEK 4580 FMS DUO+ PUMP/SHAVER COMBO; FLUID MANAGEMENT SYSTEM

Catalog Number 284580

Device Problem Failure to Pump (1502)

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

Event Date 12/04/2015

Event Type  Injury  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.The complaint device was returned and an evaluation was performed.The evaluation revealed the irrigation roller pump head was loose and pushed back against the front panel causing it to not rotate; therefore the unit had no flow.A review into the depuy synthes mitek complaints system revealed one other dissimilar complaint for this eight year old reusable pump.The device was repaired and has passed all functional and safety tests, and is fully operational.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.(b)(4).

Event Description

Per sales rep fms duo has no flow.Surgery type: hip; patient harm: none; patient delay - 60 minutes.Pump started working after the delay and the case was completed with the pump.Our sales rep confirmed via phone on (b)(6) 2016 that the patient was under anesthesia for approximately 45 minutes during the delay in procedure.He stated there were no reported adverse patient consequences.

• Brand Name: MITEK 4580 FMS DUO+ PUMP/SHAVER COMBO
• Type of Device: FLUID MANAGEMENT SYSTEM
• Manufacturer (Section D): DEPUY MITEK; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: joseph cipollo ; 325 paramount drive; raynham, MA 02767 ; 5089773839
• MDR Report Key: 5375044
• MDR Text Key: 36204458
• Report Number: 1221934-2016-10008
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK954465
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 12/04/2015,01/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2016
• 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: 01/14/2016
• Is the Reporter a Health Professional?: Yes
• Device Age: 8 YR
• Event Location: Hospital
• Date Report to Manufacturer: 12/04/2015
• Date Manufacturer Received: 12/04/2015
• 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