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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY MITEK LLC US FMS VUE PUMP DISTENSION UNIT, FLUID, ARTHROSCOPIC 

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DEPUY MITEK LLC US FMS VUE PUMP DISTENSION UNIT, FLUID, ARTHROSCOPIC  Back to Search Results
Catalog Number 284002
Device Problem Suction Failure (4039)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/11/2016
Event Type  malfunction  
Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. The complaint device is not being returned for evaluation. The sales rep troubleshot the pump and determined there was no problem with the device; rather the error code was caused by it was not in the right mode "duo". The sales rep tested the pump and returned it to service where it has been used for the last year without an issue. A review into the depuy synthes mitek complaints system revealed two other dissimilar complaints for this device's serial number. No corrective action is required and no further action is warranted at this time. 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. Dhr review: part number: 284002; supplier lot number: f10a20839; qty of lot: 12. Release to warehouse date: 3/30/2015. Manufacturing date: 3/1/2015. Supplier: (b)(4). Manufacturing site: (b)(4). Any anomalies or discrepancies in the manufacture of the lot: no. This report is being filed from the (b)(4) as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions. (b)(4).
 
Event Description
It was reported that the outflow part of the pump was not working during a shoulder decompression procedure. It was not sucking and the door appeared to have a disconnect with the tubing. There was a five minute delay swapping out the pump and no patient consequence.
 
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Brand NameFMS VUE PUMP
Type of DeviceDISTENSION UNIT, FLUID, ARTHROSCOPIC 
Manufacturer (Section D)
DEPUY MITEK LLC US
325 paramount drive
raynham MA 02767
Manufacturer (Section G)
DEPUY MITEK
325 paramount drive
raynham MA 02767
Manufacturer Contact
kara ditty-bovard
325 paramount drive
raynham, MA 02767
5089776860
MDR Report Key8281850
MDR Text Key135532397
Report Number1221934-2019-56159
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K130169
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 05/11/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/28/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/17/2019
Device Catalogue Number284002
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/29/2019
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/01/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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