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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY MITEK 4580 FMS DUO+ PUMP/SHAVER COMBO; FMS EQUIPMENT SYSTEMS
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DEPUY MITEK 4580 FMS DUO+ PUMP/SHAVER COMBO; FMS EQUIPMENT SYSTEMS Back to Search Results
Catalog Number 284580
Device Problem Unknown (for use when the device problem is not known) (2204)
Patient Problem Extravasation (1842)
Event Date 02/11/2015
Event Type  malfunction  
Event Description
During use of the machine the surgeon noticed patients shoulder swelling increased more than usual and questioned whether the pressures indicated on the machine were accurate.Surgeon has requested machine to be tested and calibrated for accuracy.He feels the pressure was higher than what the machine was reading.The machine was set at 45mm hg.Changed to a non jandj product.Swelling of patients shoulder was resolved.Five minute delay.No ae to patient.
 
Manufacturer Narrative
Attempts have been made to retrieve additional information about the event and device.The additional information will reportedly be forwarded to depuy mitek however it is not known if it will be received within the 30 day reporting requirement, therefore depuy mitek would like to file this initial medwatch report at this time.When and if additional information is received it will be reflected in a follow-up medwatch report.
 
Manufacturer Narrative
The complaint device was forwarded to the service center for evaluation.The device passed all functional and electrical tests and it was determined there was no problem with the device.No rework or repair was required.This complaint cannot be confirmed.No corrective action is required and no further action is warranted at this time.This file will remain receptive to any potential forthcoming information received that is pertinent and germane to this issue.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
During use of the machine the surgeon noticed patients shoulder swelling increased more than usual and questioned whether the pressures indicated on the machine were accurate.Surgeon has requested machine to be tested and calibrated for accuracy.He feels the pressure was higher than what the machine was reading.The machine was set at 45mm hg.Changed to a non jandj product.Swelling of patients shoulder was resolved.5 minute delay.No ae to patient.
 
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Brand Name
4580 FMS DUO+ PUMP/SHAVER COMBO
Type of Device
FMS EQUIPMENT SYSTEMS
Manufacturer (Section D)
DEPUY MITEK
325 paramount drive
quality department
raynham MA 02767
Manufacturer (Section G)
DEPUY MITEK
325 paramount drive
na
raynham MA 02767
Manufacturer Contact
bahaa nashed
325 paramount drive
quality department
raynham, MA 02767
8003824682
MDR Report Key4533784
MDR Text Key5538629
Report Number1221934-2015-00631
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K954465
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative,Distributor
Reporter Occupation Health Professional
Remedial Action Other
Type of Report Initial,Followup
Report Date 02/11/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/22/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number284580
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/10/2015
Is the Reporter a Health Professional? Yes
Distributor Facility Aware Date02/11/2015
Event Location Hospital
Date Report to Manufacturer02/11/2015
Date Manufacturer Received02/11/2015
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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