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

Catalog Number 284580

Device Problem Insufficient Information (3190)

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

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.(b)(4).

Event Description

(b)(4) fms duo+ pump/shaver combo.Please repair units and ship back to customer these are (b)(6) owned units and they need them back rep to return replacement units back to loaner pool once service, repair and shipped back to customer.Surgery type: shoulder, patient harm: none, surgery delay: 3 minutes, how surgery was completed: changed out tubing, product belongs to the customer, returning tubing and interface cables too.Additional information received by mitek complaints via phone on (b)(6) 2016: the sales rep reported that there was compartment syndrome during the procedure.No patient harm reported.

Manufacturer Narrative

The device problem was identified and confirmed.Performed service and repair functions as per (b)(4).Reviewed service history.Per (b)(4), replaced worn fingers on complete pressure adjusters (preventive maintenance) with tip replacement kits.Per (b)(4), added keyboard mask.The unit passed all diagnostic tests, functional tests, and is fully operational.No further action is warranted at this time.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.

• Brand Name: 4580 FMS DUO+ PUMP/SHAVER COMBO
• Type of Device: FMS PUMPS
• Manufacturer (Section D): DEPUY MITEK; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: jason busch ; 325 paramount drive; raynham, MA 02767 ; 5088808210
• MDR Report Key: 5530823
• MDR Text Key: 41312621
• Report Number: 1221934-2016-10107
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 03/02/2016

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2016
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Report to Manufacturer: 03/02/2016
• Initial Date Manufacturer Received: 03/02/2016
• Initial Date FDA Received: 03/29/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/03/2016
• 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): Other