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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY MITEK FMS FLUID MANAGEMENT SYSTEM INFLOW TUBING (FMS VUE) FMS TUBING

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DEPUY MITEK FMS FLUID MANAGEMENT SYSTEM INFLOW TUBING (FMS VUE) FMS TUBING Back to Search Results
Catalog Number 284508
Device Problem Break (1069)
Patient Problem No Code Available (3191)
Event Date 10/04/2016
Event Type  Injury  
Manufacturer Narrative
The complaint device is not available for a physical evaluation. No further information regarding the technique or instruments used has been provided to determine a root cause for this failure. This type of failure has been typically observed when the tubing was not seated correctly on the rollers of the pump and the clamp is pressed down causing it to split. A batch record review has been conducted and the results indicate that this batch of product was processed without any incident and therefore there is no internally assignable cause for the reported problem. Further, a review into the depuy (b)(4) complaints system revealed (b)(4) dissimilar complaints for this lot of devices that were released to distribution. At this point in time, no further action is warranted. However, should any new information be provided in future, this file will be re-opened and a thorough investigation will be performed. Depuy (b)(4) 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
The sales rep reported via phone that during a knee arthroscopy the tubing that goes to the pump on the customers fms vue irrigation tube set had a leak. The pressure chamber filled with water causing the device not to work. The sales rep states that the case was not able to be completed resulting in the surgeon having to do a fasciotomy due to pressure build up in the patients knee. The additional fasciotomy caused a 60 min delay in the procedure. The sales rep was not present during the time of the incident and the device was discarded.
 
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Brand NameFMS FLUID MANAGEMENT SYSTEM INFLOW TUBING (FMS VUE)
Type of DeviceFMS TUBING
Manufacturer (Section D)
DEPUY MITEK
325 paramount drive
raynham MA 02767
Manufacturer Contact
jennifer lawrence
325 paramount drive
raynham, MA 02767
5089776860
MDR Report Key6074547
MDR Text Key59009310
Report Number1221934-2016-10453
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K951843
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 10/04/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/02/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/31/2018
Device Catalogue Number284508
Device Lot Number931
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location Hospital
Date Report to Manufacturer10/04/2016
Date Manufacturer Received10/04/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/25/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/02/2016 Patient Sequence Number: 1
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