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 08/19/2014

Event Type  Injury  

Event Description

It was reported by the sales rep that the doctor stated that after the procedure, he had noticed the patient had a very swollen calf due to fluid from the procedure.The doctor performed a fasciotomy to relieve pressure.No patient consequences.Pump to be returned.

Manufacturer Narrative

The complaint device was received and per service bulletins, replaced standard parts.The unit passed all diagnostic tests, functional tests, and is fully operational.The reported failure cannot be recreated and therefore the failure could not be verified.No other information was provided regarding the set up and outflow.At this point, it cannot be confirmed that the pump was the root cause of this failure.Should additional information be provided in future, this complaint will be reopened and evaluated.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: 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: 4077928
• MDR Text Key: 21444916
• Report Number: 1221934-2014-00396
• 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
• Report Date: 08/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2014
• 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: 08/27/2014
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 08/19/2014
• Device Age: 5 YR
• Event Location: Hospital
• Date Report to Manufacturer: 08/20/2014
• Date Manufacturer Received: 08/20/2014
• 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