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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN KANGAROO EPUMP - NEW; ENTERAL FEEDING PUMP

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COVIDIEN KANGAROO EPUMP - NEW; ENTERAL FEEDING PUMP Back to Search Results
Model Number 382400
Device Problems Device Alarm System (1012); Device Stops Intermittently (1599)
Patient Problem No Information (3190)
Event Type  malfunction  
Manufacturer Narrative
Submit date: 09/23/2016.An investigation is currently underway.Upon completion, the results will be forwarded.
 
Event Description
It was reported to covidien on (b)(6) 2016 that a customer had an issue with an enteral feeding pump.The customer reported the unit shut off.The issue was discovered during preventative maintenance.The device was not being used on a patient.The unit did not display a countdown prior to powering off.The unit did not alarm prior to shutting off.
 
Manufacturer Narrative
An evaluation of the kangaroo joey pump was performed for the reported condition of, ¿pump ¿intermitted power¿.The unit was triaged and the reported issue could not be confirmed at this time.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.If information is provided in the future, a supplemental report will be issued.
 
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Brand Name
KANGAROO EPUMP - NEW
Type of Device
ENTERAL FEEDING PUMP
Manufacturer (Section D)
COVIDIEN
15 hampshire street
mansfield MA 02048
Manufacturer (Section G)
COVIDIEN
15 hampshire street
mansfield MA 02048
Manufacturer Contact
edward almeida
15 hampshire street
mansfield, MA 02048
5084524151
MDR Report Key5973813
MDR Text Key55874802
Report Number1282497-2016-00721
Device Sequence Number1
Product Code LZH
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 05/18/2016
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 Health Professional
Device Model Number382400
Device Catalogue Number382400
Device Lot NumberC13068289
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 05/18/2016
Initial Date FDA Received09/23/2016
Supplement Dates Manufacturer Received05/18/2016
Supplement Dates FDA Received09/18/2017
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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