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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDEN KANGAROO EPUMP - RFB; PUMP, INFUSION, ENTERAL
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COVIDEN 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
Pump s/n: (b)(4) was received and tested.The report issue was confirmed.During evaluation it was noted that there was damage to the gearbox assembly.The damaged gearbox were replaced and the pump was retested and passed all functional tests.Service history record was reviewed, this device was manufactured in 2012 and this is the first time this device has been returned for service.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 that the device was out of spec and had excess.There were no further information.
 
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Brand Name
KANGAROO EPUMP - RFB
Common Device Name
PUMP, INFUSION, ENTERAL
Manufacturer (Section D)
COVIDEN
15 hampshire street
mansfield MA 02048
MDR Report Key12072860
Report Number1282497-2021-10388
Device Sequence Number4166825
Product Code LZH
UDI-Device Identifier10884521006621
UDI-Public10884521006621
Combination Product (Y/N)N
Initial Reporter StateFL
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 03/11/2019
Initial Report FDA Received Date06/26/2021
Patient Sequence Number1
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