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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MOOG MEDICAL DEVICES GROUP; FEEDING PUMP
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MOOG MEDICAL DEVICES GROUP; FEEDING PUMP Back to Search Results
Device Problems Device Displays Incorrect Message (2591); Infusion or Flow Problem (2964)
Patient Problem No Information (3190)
Event Date 12/24/2014
Event Type  malfunction  
Event Description
The feeding pump was programmed to deliver 210ml of ketogenic formula over 1 hour.A couple of times, the pump rang off, "no flow," so the rn primed the tubing to make sure there was not a clot because the formula was thick.It primed with no problem.The pump was started again after each prime, and was running and appeared to be administering the formula.The pump rang off, "dose complete" saying it administered 210ml, but the bottle was full and no formula was actually administered.Manufacturer (moog/nestle) has been notified of incident.The manufacturer is in communication with bio-med engineering.As i understand it, the pump has been pulled from service and the manufacturer plans to send someone out to look at it.
 
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Type of Device
FEEDING PUMP
Manufacturer (Section D)
MOOG MEDICAL DEVICES GROUP
10805 rancho bernardo rd
san diego CA 92127
MDR Report Key4506758
MDR Text Key5488463
Report Number4506758
Device Sequence Number1
Product Code LZH
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 01/02/2015
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 Nurse
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/02/2015
Event Location Hospital
Date Report to Manufacturer02/11/2015
Initial Date Manufacturer Received Not provided
Initial Date FDA Received01/02/2015
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
UNKNOWN.
Patient Age5 YR
Patient Weight15
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