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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 Problem Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
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 states the units rate fluctuates and has a system error.
 
Manufacturer Narrative
Evaluation of the kangaroo pump was performed and the customer states, ¿the units rate fluctuates.¿ the unit was triaged by failure investigation and the customer¿s reported condition was confirmed.A trend has been identified and a corrective action has been opened to address this issue.All device history records are reviewed for quality inspections and parameter compliance prior to releasing the product for shipment.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
building # 10, 789 puxing road
shanghai
CH 
MDR Report Key6120536
MDR Text Key60938083
Report Number3006451981-2016-00601
Device Sequence Number1
Product Code LZH
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial,Followup
Report Date 08/24/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/22/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number382400
Device Catalogue Number382400
Was Device Available for Evaluation? Yes
Date Manufacturer Received10/05/2016
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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