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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 04/24/2018
Event Type  malfunction  
Manufacturer Narrative
If additional information should become available, a supplemental medwatch will be submitted accordingly. Udi: (b)(4). Per service manual operational and diagnostic analysis does not confirm the reported issue (unit has no suction / pump will not turn when handpiece is activated). The testing of the unit was completed per the service manual. The unit passed all functional tests and is fully operational. No further investigation beyond what is noted below will be conducted on this complaint. Replaced worn fingers on pressure arm housing (preventive maintenance) with tip replacement kit.
 
Event Description
It was reported by the customer that during knee repair arthroscopy surgical procedure, it was observed that the fms vue pump device had no suction and its pump would not turn when handpiece was activated. There was a delay of less than one minute and the surgery was completed with another identical spare device. There was patient involvement reported. There were no 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.
 
Manufacturer Narrative
Product complaint #
==
> (b)(4). Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803. This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date. This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report. Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. Evaluation statement: the device was received at the service center and evaluated. Per service manual operational and diagnostic analysis does not confirm the reported issue (unit has no suction / pump will not turn when handpiece is activated). The testing of the unit was completed per the service manual. The unit passed all functional tests and is fully operational. No further investigation beyond what is noted below will be conducted on this complaint. Replaced worn fingers on pressure arm housing (preventive maintenance) with tip replacement kit. 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. Udi: (b)(4).
 
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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
MDR Report Key8046007
MDR Text Key126385203
Report Number1221934-2018-55217
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
PMA/PMN Number
K130169
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 04/24/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/07/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/23/2017
Device Catalogue Number284002
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/09/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/18/2018
Is This a Reprocessed and Reused Single-Use Device? No

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