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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN LP KANGAROO; SET, PUMP, INFUSION, ENTERAL
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COVIDIEN LP KANGAROO; SET, PUMP, INFUSION, ENTERAL Back to Search Results
Model Number 773656
Device Problems Device Alarm System (1012); Fluid/Blood Leak (1250); Hole In Material (1293); Device Displays Incorrect Message (2591)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/12/2018
Event Type  malfunction  
Event Description
The nurse had just changed the tube feeding bag; the pump beeping went to and nurse room to respond to alarm.Noticed the bag had a hole in the bottom and water was dripping out.Nurse collected the packaging and tubing and the nurse changed out the tubing set.No harm to the patient.Per site reporter: waiting to be contacted by product assurance per customer service.
 
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Brand Name
KANGAROO
Type of Device
SET, PUMP, INFUSION, ENTERAL
Manufacturer (Section D)
COVIDIEN LP
15 hampshire street
mansfield MA 02048
MDR Report Key7471926
MDR Text Key106868175
Report Number7471926
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 User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 04/16/2018
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 Expiration Date11/30/2020
Device Model Number773656
Device Catalogue Number773656
Device Lot Number173560095
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/16/2018
Event Location Hospital
Date Report to Manufacturer04/16/2018
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/30/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Treatment
NO
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