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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN KANGAROO EPUMP - RFB; PUMP, INFUSION, ENTERAL
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COVIDIEN KANGAROO EPUMP - RFB; PUMP, INFUSION, ENTERAL Back to Search Results
Model Number 382401
Medical Device Problem Code Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 12/21/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
An evaluation of the kangaroo epump was performed.The unit was triaged and the reported issue could not be confirmed at this time.An accuracy test was completed using 125ml of water and the pump delivered the rate it was expected to.All device history records are reviewed for quality inspections and parameter compliance prior to releasing the product for shipment.Complaint trending information is being reviewed on a monthly basis and if a trend is observed, actions will be taken as necessary.
 
Event or Problem Description
The customer reported that the enteral feeding pump infused more than what it was programmed to.
 
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Brand Name
KANGAROO EPUMP - RFB
Common Device Name
PUMP, INFUSION, ENTERAL
Manufacturer (Section D)
COVIDIEN
15 hampshire street
mansfield MA 02048
MDR Report Key9953615
Report Number1282497-2020-09004
Device Sequence Number2789144
Product Code LZH
UDI-Device Identifier10884521006621
UDI-Public10884521006621
Combination Product (Y/N)N
Initial Reporter StateAZ
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source user facility
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 04/13/2020
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
Operator of Device No Information
Device Model Number382401
Device Catalogue Number382401
Was Device Available for Evaluation? Yes
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 03/18/2020
Initial Report FDA Received Date04/13/2020
Patient Sequence Number1
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