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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN KANGAROO JOEYPUMP W/POLE CLMP; PUMP, INFUSION, ENTERAL

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COVIDIEN KANGAROO JOEYPUMP W/POLE CLMP; PUMP, INFUSION, ENTERAL Back to Search Results
Model Number 383400
Device Problem Excess Flow or Over-Infusion (1311)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
The incident device has been requested but to date has not been received for evaluation.If the device is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
 
Event Description
The customer reported that the kangaroo joey enteral feeding pump overfilled by 10+ml.There was no patient harm reported.
 
Manufacturer Narrative
An evaluation of the kangaroo pump was performed.The unit was triaged and the reported issue was confirmed.After review, it was determined that the flex cable was damaged due to misuse.Also, the software needed to be reinstalled.The flex cable was replaced.The software was reinstalled.The gasket and tire were also replaced due to opening the unit.The pump was tested and the problem was resolved.The pump is working as intended.No further actions are required at this time.Complaint trending information is being reviewed on a monthly basis and if a trend is observed, actions will be taken as necessary.
 
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Brand Name
KANGAROO JOEYPUMP W/POLE CLMP
Type of Device
PUMP, INFUSION, ENTERAL
Manufacturer (Section D)
COVIDIEN
15 hampshire street
mansfield MA 02048
MDR Report Key12408411
MDR Text Key269535371
Report Number1282497-2021-10585
Device Sequence Number1
Product Code LZH
UDI-Device Identifier10884521006645
UDI-Public10884521006645
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 10/14/2021
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
Device Operator No Information
Device Model Number383400
Device Catalogue Number383400
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 08/11/2021
Initial Date FDA Received09/01/2021
Supplement Dates Manufacturer Received08/11/2021
Supplement Dates FDA Received10/14/2021
Patient Sequence Number1
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