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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDINAL HEALTH KANGAROO JOEYPUMP W/POLE CLMP; PUMP, INFUSION, ENTERAL
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CARDINAL HEALTH KANGAROO JOEYPUMP W/POLE CLMP; PUMP, INFUSION, ENTERAL Back to Search Results
Model Number 383400
Medical Device Problem Code Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code Insufficient Information (4580)
Date of Event 09/07/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The incident sample has been requested but to date has not been received for evaluation. if the sample 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 or Problem 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.
 
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Brand Name
KANGAROO JOEYPUMP W/POLE CLMP
Common Device Name
PUMP, INFUSION, ENTERAL
Manufacturer (Section D)
CARDINAL HEALTH
15 hampshire street
mansfield MA 02048
MDR Report Key12455287
Report Number1282497-2021-10612
Device Sequence Number14724380
Product Code LZH
UDI-Device Identifier10884521006645
UDI-Public10884521006645
Combination Product (Y/N)N
Initial Reporter CountryIT
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 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
Operator of Device No Information
Device Model Number383400
Device Catalogue Number383400
Was Device Available for Evaluation? Yes
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 09/08/2021
Initial Report FDA Received Date09/10/2021
Patient Sequence Number1
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