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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN KANGAROO EPUMP - NEW; PUMP, INFUSION, ENTERAL
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COVIDIEN KANGAROO EPUMP - NEW; PUMP, INFUSION, ENTERAL Back to Search Results
Model Number 382400
Medical Device Problem Code Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Pump s/n: (b)(4) was received and could not be tested to confirm the reported issue due to physical damage.During visual evaluation it was noted that all internal components were damaged.The damaged parts were replaced.The pump was tested and passed all functional test.The service history record was reviewed.The device was manufactured in 2013.This is the first time this device has been returned for service.The damaged components were determined to be caused by customer mishandling of the device.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 device had high feed rate.
 
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Brand Name
KANGAROO EPUMP - NEW
Common Device Name
PUMP, INFUSION, ENTERAL
Manufacturer (Section D)
COVIDIEN
15 hampshire street
mansfield MA 02048
MDR Report Key12072896
Report Number1282497-2021-10423
Device Sequence Number3564822
Product Code LZH
UDI-Device Identifier10884521006614
UDI-Public10884521006614
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,user f
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 06/26/2021
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 Number382400
Device Catalogue Number382400
Was Device Available for Evaluation? Yes
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 06/13/2019
Initial Report FDA Received Date06/26/2021
Patient Sequence Number1
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