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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN KANGAROO; PUMP, INFUSION, ENTERAL
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COVIDIEN KANGAROO; PUMP, INFUSION, ENTERAL Back to Search Results
Catalog Number 773656
Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)
Patient Problem No Information (3190)
Event Date 11/25/2014
Event Type  malfunction  
Event Description
Patient was receiving tube feeds continuously and around 0415 pump started alarming.Checked patient- nothing was clamped and patient's nasogastric tube (ng) flushed easily.There were feeds in bag.Restarted.Continued alarming error.Changed bag and changed pump.At this point, the new bag and new pump were not priming- would get to motor area and would not prime with formula.Attempted with another pump and bag.Then, with trial and error, it was discovered that it was the bag and not the pumps.Ultimately took a 4th bag from clean room #1, way in the back/bottom of shelf and this bag works.The first three bags came from clean room #2.
 
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Brand Name
KANGAROO
Type of Device
PUMP, INFUSION, ENTERAL
Manufacturer (Section D)
COVIDIEN
15 hampshire street
mansfield, MA 02048
MDR Report Key5334263
MDR Text Key34650813
Report Number5334263
Device Sequence Number1
Product Code LZH
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 11/17/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Catalogue Number773656
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/29/2014
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/17/2015
Event Location Hospital
Date Report to Manufacturer11/17/2015
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/30/2015
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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