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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN LLC KANGAROO EPUMP SAFETY SCREW SPIKE WITH FLUSH BAG; PUMP, INFUSION, ENTERAL

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COVIDIEN LLC KANGAROO EPUMP SAFETY SCREW SPIKE WITH FLUSH BAG; PUMP, INFUSION, ENTERAL Back to Search Results
Catalog Number 775100
Device Problems Fluid/Blood Leak (1250); Difficult to Insert (1316); Failure to Advance (2524)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/22/2014
Event Type  malfunction  
Event Description
Patient receiving enteric feeding using the kangaroo e pump.New tubing and feeding were to be started.Rn had difficulty in spiking the feeding bottle.It would not screw into place and leaked all over the floor.Another e pump safety screw spike with flush bag was obtained.The feeding bottle inserted correctly this time.Next, the tubing pump set was inserted into the pump chamber.The finger tab was placed on the valve, the stretch tubing placed around the rotor and the retainer inserted into the right pocket.The pump was set to prime but no feeding advanced.The rotor and valve assembly were moving but feeding would not advance.A new pump was tried with this tubing and the same thing happened.A third tubing set was tried with the same failure to advance the feeding.This event resulted in a delay in nutritional therapy to the patient.
 
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Brand Name
KANGAROO EPUMP SAFETY SCREW SPIKE WITH FLUSH BAG
Type of Device
PUMP, INFUSION, ENTERAL
Manufacturer (Section D)
COVIDIEN LLC
15 hampshire st
mansfield MA 02048
MDR Report Key3772252
MDR Text Key4438095
Report Number3772252
Device Sequence Number2
Product Code LZH
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Type of Report Initial
Report Date 04/22/2014
3 Devices were Involved in the Event: 1   2   3  
1 Patient was Involved in the Event
Date FDA Received04/22/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Invalid Data
Device Catalogue Number775100
Device Lot Number140340055X
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/22/2014
Event Location Hospital
Date Report to Manufacturer04/25/2014
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
COVIDIEN KANGAROO E PUMP (382400)
Patient Age27 YR
Patient Weight110
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