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U.S. Department of Health and Human Services

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

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DEPUY MITEK 4590 FMS SOLO IRRIGATION PUMP MITEK FMS PUMPS Back to Search Results
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.
 
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Brand Name4590 FMS SOLO IRRIGATION PUMP
Type of DeviceMITEK 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 Key6320088
MDR Text Key67082258
Report Number1221934-2017-10050
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K002040
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/03/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/09/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number284590
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/11/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location Hospital
Date Report to Manufacturer08/03/2016
Date Manufacturer Received02/16/2017
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 Treatment Data
Date Received: 02/09/2017 Patient Sequence Number: 1
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