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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
Model Number 284002
Device Problem Suction Failure (4039)
Patient Problem Not Applicable (3189)
Event Date 10/15/2020
Event Type  malfunction  
Manufacturer Narrative
Product complaint #: (b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Udi: (b)(4).
 
Event Description
Per sales rep no suction, no patient harm, 5 minute delay, rotator repair, completed with different fms pump.
 
Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: investigation summary: the device was received and evaluated at the service center.The reported complaint that the pump had no suction was confirmed.It was found that the suction pressure arm assembly was locking up causing the suction issue.There were also minor scratches on the device identified during decontamination.The service of the device was however declined and was placed into long-term hold as it was not needed for the equipment exchange pool use.Given the information provided, we cannot discern a definitive root cause of the rocker arm failure.The minor scratches on the device are most likely a result of user mishandling of the device.A manufacturing record evaluation was performed for the finished device (serial number : (b)(6)), and no non-conformances were identified.At this point in time, no corrective action is required, and no further action is warranted.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.
 
Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: h4: the device manufacture date was reported as unknown on the initial report.It has been updated accordingly.D10, h3, h6: the actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
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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 Key10760026
MDR Text Key214148303
Report Number1221934-2020-03250
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
Type of Report Initial,Followup,Followup
Report Date 10/15/2020
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 Expiration Date03/23/2017
Device Model Number284002
Device Catalogue Number284002
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/14/2020
Initial Date Manufacturer Received 10/15/2020
Initial Date FDA Received10/30/2020
Supplement Dates Manufacturer Received11/24/2020
12/03/2020
Supplement Dates FDA Received11/25/2020
12/04/2020
Removal/Correction NumberN/A
Patient Sequence Number1
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