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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY MITEK 4580 FMS DUO+ PUMP/SHAVER COMBO MITEK FMS PUMPS

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DEPUY MITEK 4580 FMS DUO+ PUMP/SHAVER COMBO MITEK FMS PUMPS Back to Search Results
Catalog Number 284580
Device Problem Device Operational Issue (2914)
Patient Problem No Code Available (3191)
Event Date 09/29/2016
Event Type  Injury  
Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. (b)(4).
 
Event Description
It was reported by the biomed that during a unknown procedure the pump run off suddenly and the fill chamber was full. There is a risk that some liquid went through the pressure sensor inside the pump. Hotline agent recommend to stop using the pump and send it to repair. The call was during the procedure with patient on table, at that moment they did not know how they will complete the case. No patient consequences. Additional information received via email 9-29-2016. I have got more information about this case. The surgeon had to change the technique because he could not use the pump anymore and did not have a spare one. They opened directly the patient. The surgery delay was over 30 minutes, and there is no consequences on the patient.
 
Manufacturer Narrative
The defect reported could not be verified. A review into the depuy mitek complaints system revealed two other complaints for this serial number with pressure issues. Root cause for the reported failure could not be determined as there was no issue found with the device. At this point in time, no further action is warranted. However, should any new information be provided in future, this file will be re-opened and a thorough investigation will be performed. 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.
 
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Brand Name4580 FMS DUO+ PUMP/SHAVER COMBO
Type of DeviceMITEK FMS PUMPS
Manufacturer (Section D)
DEPUY MITEK
325 paramount drive
raynham MA 02767
Manufacturer Contact
jennifer lawrence
325 paramount drive
raynham, MA 02767
5089776860
MDR Report Key6062780
MDR Text Key58600158
Report Number1221934-2016-10451
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 company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/29/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/28/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number284580
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/07/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location Hospital
Date Report to Manufacturer09/29/2016
Date Manufacturer Received06/06/2017
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 Treatment Data
Date Received: 10/28/2016 Patient Sequence Number: 1
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