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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
Device Problem Excess Flow or Over-Infusion (1311)
Patient Problem Insufficient Information (4580)
Event Date 09/07/2021
Event Type  malfunction  
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 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.
 
Manufacturer Narrative
The service history record was reviewed and indicated that this is the first time that this kangaroo joey enteral feeding pump has been returned to the service center.The pump was decontaminated with an isopropyl alcohol wipe and an evaluation of the pump was performed.The unit was tested, and the reported issue could not be confirmed at this time.However, the software, battery, and overlay were found to be old and were replaced for this reason.A corrective action is not applicable at this time.Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.This complaint will be used for tracking and trending purposes.
 
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Brand Name
KANGAROO JOEYPUMP W/POLE CLMP
Type of Device
PUMP, INFUSION, ENTERAL
Manufacturer (Section D)
CARDINAL HEALTH
15 hampshire street
mansfield MA 02048
Manufacturer (Section G)
CARDINAL HEALTH
15 hampshire street
mansfield MA 02048
Manufacturer Contact
jill saraiva
15 hampshire street
mansfield, MA 02048
5086183640
MDR Report Key12453582
MDR Text Key272124321
Report Number1282497-2021-10600
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,Followup
Report Date 09/27/2021
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
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 09/08/2021
Initial Date FDA Received09/10/2021
Supplement Dates Manufacturer Received09/08/2021
Supplement Dates FDA Received09/27/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Type of Device Usage N
Patient Sequence Number1
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