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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 11/13/2018
Event Type  malfunction  
Manufacturer Narrative
If additional information should become available, a supplemental medwatch will be submitted accordingly. (b)(4). As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
It was reported by the sales rep via phone that during a rotator cuff repair procedure, it was observed that the outflow on the customer's fms vue pump device did not have suction and its inflow chamber was not filling. The sales rep stated they replaced the tubing and powered off the pump, but the pump would not turn back on. The sales rep stated that there was no swelling in the patient due to the outflow suction failure. The case was completed with another pump with no patient harm, but there was a ten minute delay to change the tubing and change the pump. The device is being returned for evaluation. 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
(b)(4). If information is obtained that was not available for the initial medwatch. A follow-up medwatch will be filed as appropriate. (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 Key8119972
MDR Text Key128898310
Report Number1221934-2018-55471
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup
Report Date 11/13/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/30/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number284002
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/10/2019
Is This a Reprocessed and Reused Single-Use Device? No

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