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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 08/07/2018
Event Type  malfunction  
Manufacturer Narrative
If additional information should become available, a supplemental medwatch will be submitted accordingly. (b)(4). Investigation summary: the device was received at the service center and evaluated. Per service manual operational and diagnostic analysis confirmed reported issue (device is not pairing correctly). Root cause identified as fms vue eprom needing replacement. Replaced fms vue eprom and performed software upgrade to 3. 11 and cpld version upgraded to 1. 7 (see form in attachments) as identified in the investigation to address the reported issue. Also replaced right side door assy. (missing magnet) to correct suction issue. The repair and testing of the unit was completed per the service manual, bringing the unit back to full functionality. The unit passed all functional tests and is fully operational. A review of the device history record indicated that this lot of product was processed without incident; therefore, there is no evidence of manufacturing anomalies on the paperwork reviewed. 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.
 
Event Description
It was reported by the sales rep that prior to an unknown surgical procedure, it was observed that the fms vue pump device was not pairing correctly. During in-house engineering evaluation, it was determined that the device had a suction issue. There was no delay in the surgery as another pump device was available for use to complete the procedure successfully. This event did not occur during surgery. There was no patient involvement reported. There were no reports of injuries, medical intervention or prolonged hospitalization. All available information has been disclosed. If additional information should become available, a supplemental medwatch report will be submitted accordingly.
 
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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 LLC US
325 paramount drive
raynham MA 02767
Manufacturer Contact
kara ditty-bovard
325 paramount drive
raynham, MA 02767
6103142063
MDR Report Key8150270
MDR Text Key129897078
Report Number1221934-2018-55637
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
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/10/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/11/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number284002
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/12/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/10/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured01/28/2014
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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