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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY MITEK MITEK FMS DUO PUMP; FLUID MANAGEMENT SYSTEM
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DEPUY MITEK MITEK FMS DUO PUMP; FLUID MANAGEMENT SYSTEM Back to Search Results
Catalog Number 284580
Device Problems Unknown (for use when the device problem is not known) (2204); Overfill (2404)
Patient Problem Extravasation (1842)
Event Date 06/26/2015
Event Type  Injury  
Event Description
It was reported by the rep the fill chamber filled to the top and the inflow pump ramped up caused an over pressure condition.This was at the end of the procedure.The procedure was completed with no patient consequences reported.The device will be returned.Additional information received by mitek complaints by phone on 7-14-15: the sales rep called back to confirm there were patient consequences.The fill chamber overfilled and drained into the patient's shoulder causing extravasation.The surgeon was near the end of the procedure and ended the surgery sooner than he had planned.The sales rep reported no delays because of this.The sales rep reported that the fixation was complete and no additional surgery is planned.The patient shoulder was manually drained and the patient was monitored for an additional time but he was able to go home the same day.
 
Manufacturer Narrative
Attempts have been made to retrieve additional information about the event and device.The additional information will reportedly be forwarded to depuy synthes mitek however it is not known if it will be received within the 30 day reporting requirement, therefore depuy synthes 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 returned for evaluation.The pump passed all tests and it was determined there was no problem with the device.The reported failure of the fill chamber filling to the top and the inflow pump ramping up could not be duplicated, even though the fingers on pressure adjusters are worn.This complaint cannot be confirmed.Further a review into the depuy synthes mitek complaints system revealed no other complaints for this device's serial number.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.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
It was reported by the rep the fill chamber filled to the top and the inflow pump ramped up caused an over pressure condition.This was at the end of the procedure.The procedure was completed with no patient consequences reported.The device will be returned.Additional information received by mitek complaints by phone on 7-14-15: the sales rep called back to confirm there were patient consequences.The fill chamber overfilled and drained into the patient's shoulder causing extravasation.The surgeon was near the end of the procedure and ended the surgery sooner than he had planned.The sales rep reported no delays because of this.The sales rep reported that the fixation was complete and no additional surgery is planned.The patient shoulder was manually drained and the patient was monitored for an additional time but he was able to go home the same day.
 
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Brand Name
MITEK FMS DUO PUMP
Type of Device
FLUID MANAGEMENT SYSTEM
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 Key4938862
MDR Text Key6254640
Report Number1221934-2015-00880
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K954465
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative,company representati
Reporter Occupation Health Professional
Remedial Action Other
Type of Report Initial
Report Date 06/26/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/24/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number284580
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/01/2015
Is the Reporter a Health Professional? Yes
Distributor Facility Aware Date06/26/2015
Device Age9 YR
Event Location Hospital
Date Report to Manufacturer06/26/2015
Date Manufacturer Received06/26/2015
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
Patient Outcome(s) Required Intervention;
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