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U.S. Department of Health and Human Services

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

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COVIDIEN KANGAROO JOEYPUMP W/POLE CLMP; PUMP, INFUSION, ENTERAL Back to Search Results
Model Number 383400
Device Problem Excess Flow or Over-Infusion (1311)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/07/2021
Event Type  malfunction  
Manufacturer Narrative
The incident device 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.
 
Event Description
The customer reported that the device's flow was not conforming.Additional information was provided stating that the issue happened during reconditioning test.The device flowed faster than the set rate.No further information provided.
 
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Brand Name
KANGAROO JOEYPUMP W/POLE CLMP
Type of Device
PUMP, INFUSION, ENTERAL
Manufacturer (Section D)
COVIDIEN
15 hampshire street
mansfield MA 02048
Manufacturer (Section G)
COVIDIEN
15 hampshire street
mansfield MA 02048
Manufacturer Contact
jill saraiva
777 west street
mansfield, MA 02048
5086183640
MDR Report Key12454129
MDR Text Key270851223
Report Number1282497-2021-10603
Device Sequence Number1
Product Code LZH
UDI-Device Identifier10884521006645
UDI-Public10884521006645
Combination Product (y/n)N
Reporter Country CodeIT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other
Type of Report Initial
Report Date 09/10/2021
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
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 09/08/2021
Initial Date FDA Received09/10/2021
Is the Device Single Use? No
Type of Device Usage N
Patient Sequence Number1
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