MAUDE Adverse Event Report: DEPUY MITEK 4590 FMS SOLO IRRIGATION PUMP; MITEK FMS PUMPS

Catalog Number 284590

Device Problem Insufficient Information (3190)

Patient Problem Swelling (2091)

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

Fms solo irrigation pump [(b)(6)]; during knee procedure excess fluid build up in the knee.Tubing was switched out and procedure completed.Approximately 5 to 10 minute delay in procedure.No patient harm.

Manufacturer Narrative

The complaint device was returned to the service center for evaluation.The device failed pressure air tightness during test.A worn finger on the complete pressure adjuster caused the device's pressure to drop during evaluation testing, confirming this complaint.A review of the depuy synthes mitek complaint system revealed no other complaints of any kind for the nine year old complaint device.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.

• Brand Name: 4590 FMS SOLO IRRIGATION PUMP
• Type of Device: MITEK FMS PUMPS
• Manufacturer (Section D): DEPUY MITEK; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: jennifer lawrence ; 325 paramount drive; raynham, MA 02767 ; 5089776860
• MDR Report Key: 6320088
• MDR Text Key: 67082258
• Report Number: 1221934-2017-10050
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K002040
• 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,Followup
• Report Date: 08/03/2016

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: 284590
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/03/2016
• Initial Date Manufacturer Received: 08/03/2016
• Initial Date FDA Received: 02/09/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/10/2017
• 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