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U.S. Department of Health and Human Services

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

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COVIDIEN JAPAN KANGAROO EPUMP; ENTERAL FEEDING PUMP Back to Search Results
Model Number 782400
Device Problem Device Displays Incorrect Message (2591)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/14/2016
Event Type  malfunction  
Manufacturer Narrative
An investigation is currently underway.Upon completion, a full report shall be provided.
 
Event Description
It was reported to covidien on (b)(6) 2016 that the customer experienced an issue with an enteral feeding pump.The customer states: flow volume error occurred.The unit was set to deliver 300ml of formula at a rate of 40ml/h.The unit finished feeding after 4 hours.No patient harm.
 
Manufacturer Narrative
Submit date: 10/13/2016.An investigation of kangaroo epump was performed for the reported condition of, ¿flow volume error occurred, it was set 300ml of formula as 40ml/h and it finished feeding after 4 hours.¿ the unit was triaged and the complaint was confirmed.The unit was set to deliver 300 ml at a rate of 40 ml/hr; the unit completed feeding after 5 hours and 43 minutes; outside of feeding range.The root cause of the failure was due to the unit¿s gearbox; the gearbox was replaced.Kangaroo epump was manufactured in 2011.A review of the device history record shows this device was released meeting all manufacturing specifications.
 
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Brand Name
JAPAN KANGAROO EPUMP
Type of Device
ENTERAL FEEDING PUMP
Manufacturer (Section D)
COVIDIEN
building # 10, 789 puxing road
shanghai
CH 
Manufacturer (Section G)
COVIDIEN
building # 10, 789 puxing road
shanghai
CH  
Manufacturer Contact
edward almeida
15 hampshire street
mansfield, MA 02048
5084524151
MDR Report Key5554844
MDR Text Key42753411
Report Number1282497-2016-00095
Device Sequence Number1
Product Code LZH
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 03/28/2016
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 Other
Device Model Number782400
Device Catalogue Number782400
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 03/28/2016
Initial Date FDA Received04/07/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received10/13/2016
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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