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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN "KANGAROO JOEY,PUMP W/POLE CLMP"; PUMP, INFUSION, ENTERAL

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COVIDIEN "KANGAROO JOEY,PUMP W/POLE CLMP"; PUMP, INFUSION, ENTERAL Back to Search Results
Model Number 383400
Device Problem Excess Flow or Over-Infusion (1311)
Patient Problem Pain (1994)
Event Date 12/03/2018
Event Type  malfunction  
Manufacturer Narrative
The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.
 
Event Description
The customer stated that the kangaroo joey pump that was used delivered at a higher rate than what was set to be delivered.The user stated that the 43 ml should have been delivered in 1 hour; however, 100ml were delivered in 45 minutes.Feeding was complete 2.5 hours before it should have completed.The user said that she experienced a lot of pain due to the over feeding however there was no medical intervention required as result.The customer was unable to provide the serial number of the enteral feeding pump.The customer is unable to determine if the unit will be returned for service as she returned it to her medical equipment company.
 
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Brand Name
"KANGAROO JOEY,PUMP W/POLE CLMP"
Type of Device
PUMP, INFUSION, ENTERAL
Manufacturer (Section D)
COVIDIEN
15 hampshire st
mansfield MA 02048
Manufacturer (Section G)
COVIDIEN
15 hampshire street
mansfield MA 02048
Manufacturer Contact
jill saraiva
15 hampshire street
mansfield, MA 02048
5084524970
MDR Report Key8143007
MDR Text Key129761513
Report Number1282497-2018-08196
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 Manufacturer
Source Type consumer
Reporter Occupation Other
Type of Report Initial
Report Date 12/07/2018
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 Model Number383400
Device Catalogue Number383400
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/03/2018
Initial Date FDA Received12/07/2018
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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