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U.S. Department of Health and Human Services

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

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COVIDIEN KANGAROO EPUMP - NEW; PUMP, INFUSION, ENTERAL Back to Search Results
Model Number 382400
Device Problem Excess Flow or Over-Infusion (1311)
Patient Problem Abdominal Distention (2601)
Event Type  malfunction  
Manufacturer Narrative
The device involved in this incident has been requested but to date has not been received for evaluation. if the device is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted. as part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
 
Event Description
The customer reported that when giving the initial feeding with the kangaroo pump, which was the first time the pump was being used with this patient, they noticed the screen looked different than usual.There was an interval bolus and some other words regarding a bolus on the pump¿s screen that they had never seen before.They continued to program the pump as they were accustomed to.The patient was to receive one bolus of 320ml at 320ml/hr.The pump did not alarm that the feeding was complete.Upon examining the tube feed container, they noted that more than 320ml was gone.They tried to clear the volume on the pump to see how much the patient had received but there was no option to view the amount of intake or to see how much the patient had took in.There was an entry for boluses administered which said one, but the patient had definitely received more than one bolus, it was more likely two boluses of tf.The kangaroo pump had continued to give the tf bolus every hour, so the patient received two 320 boluses instead of stopping after one feed.The nurse practitioner was notified right away and 350ml was removed from the patient¿s gastric tube.The patient reported feeling distended but better after the 350ml was removed.The patient¿s lungs were also auscultated for any crackles or adventitious sounds and none were noted.The patient did not vomit.
 
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Brand Name
KANGAROO EPUMP - NEW
Type of Device
PUMP, INFUSION, ENTERAL
Manufacturer (Section D)
COVIDIEN
15 hampshire street
mansfield MA
Manufacturer (Section G)
COVIDIEN
15 hampshire street
mansfield MA 02048
Manufacturer Contact
jill saraiva
15 hampshire street
mansfield, MA 02048
5086183640
MDR Report Key9494950
MDR Text Key171998420
Report Number1282497-2019-08831
Device Sequence Number1
Product Code LZH
UDI-Device Identifier10884521006614
UDI-Public10884521006614
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other,use
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 12/19/2019
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
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 12/11/2019
Initial Date FDA Received12/19/2019
Is the Device Single Use? No
Type of Device Usage N
Patient Sequence Number1
Patient Age75 YR
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