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

Model Number	383400
Medical Device Problem Codes	Inaccurate Flow Rate (1249); Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	Feeding Problem (1850)
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 was overfeeding.
Additional Manufacturer Narrative
An evaluation of the kangaroo pump was performed.The unit was tested based on an accuracy test using 125ml of water.The delivered rate was as expected.The unit was within tolerance specifications.The unit¿s software was reinstalled as a preventative measure.The battery was replaced due to being out of date.The gasket and tie were replaced due to opening the unit.The pip pcb was replaced due to corrosion.The serial number label was replaced due to be illegible.No further actions are required at this time.Complaint trending information is being reviewed on a monthly basis and if a trend is observed, actions will be taken as necessary.

• Brand Name: KANGAROO JOEYPUMP W/POLE CLMP
• Common Device Name: 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 Key: 12336486
• Report Number: 1282497-2021-10551
• Device Sequence Number: 20005277
• Product Code: LZH
• UDI-Device Identifier: 10884521006645
• UDI-Public: 10884521006645
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2021

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 Model Number: 383400
• Device Catalogue Number: 383400
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/11/2021
• Supplement Date Received by Manufacturer: 08/11/2021
• Initial Report FDA Received Date: 08/18/2021
• Supplement Report FDA Received Date: 11/06/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown