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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 Not Applicable (3189)
Event Date 01/13/2019
Event Type  malfunction  
Manufacturer Narrative
Product complaint : (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).
 
Event Description
It was reported by the sales rep via phone that during a shoulder procedure the outflow of the fms vue pump was not working.The procedure was completed in solo mode with no patient harm but there was a 10 minute surgical delay.
 
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.Additional narrative: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary : the complaint device was received and evaluated at the service and repair center.Per service manual, operational and diagnostic analysis does not confirm the reported issue (outflow not working).Hence, this complaint cannot be confirmed nor can we determine a definite root cause for the reported failure.However, another deficiency was found to be impairing the functionality of the device.The pinch valve guard is damaged, this could have led the customer to experience the device not to function as intended.However, the repair and testing of the unit will not be completed at this time because there is no need for it in the pool due to excess units in the pool at this time.A manufacturing record evaluation was performed for the finished device serial number (e43a20745), and no non-conformances were identified.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 Name
FMS VUE PUMP
Type of Device
DISTENSION UNIT, FLUID, ARTHROSCOPIC
Manufacturer (Section D)
DEPUY MITEK LLC US
325 paramount drive
raynham MA 02767
MDR Report Key8499641
MDR Text Key141468449
Report Number1221934-2019-56802
Device Sequence Number1
Product Code HRX
UDI-Device Identifier10886705020591
UDI-Public10886705020591
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,other
Type of Report Initial,Followup
Report Date 03/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number284002
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/03/2019
Initial Date Manufacturer Received 03/14/2019
Initial Date FDA Received04/10/2019
Supplement Dates Manufacturer Received05/13/2019
Supplement Dates FDA Received05/13/2019
Patient Sequence Number1
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