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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 Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The pump, s/n: (b)(4), was received and tested.The reported failure mode was confirmed.During the evaluation it was noted that there was damage to the pcba.The damaged parts were replaced.The pump was retested and passed all functional tests.Service history record was reviewed, this device was manufactured in 2015.This is the second time this device was returned for service.The pump was 100% at the time of the last release on (b)(6) 2018.The reported event was 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 an issue of too much liquid.
 
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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 Key12072904
Report Number1282497-2021-10429
Device Sequence Number11615893
Product Code LZH
UDI-Device Identifier10884521006621
UDI-Public10884521006621
Combination Product (Y/N)N
Initial Reporter StateTN
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 Number382401
Device Catalogue Number382401
Was Device Available for Evaluation? Yes
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 06/11/2020
Initial Report FDA Received Date06/26/2021
Patient Sequence Number1
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