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

Model Number 383400

Device Problems Inaccurate Flow Rate (1249); Excess Flow or Over-Infusion (1311)

Patient Problem Feeding Problem (1850)

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 had 10 ml overfill.

Manufacturer Narrative

H3 evaluation summary: the service history record was reviewed and indicated that this is the first time that this unit has been returned for service.An evaluation of the kangaroo pump was performed.The unit was triaged, and the reported issue was not confirmed.During evaluation the software was updated.The gasket, tie, back case, cover buzzer, and foam battery were replaced due to opening the unit.The harness, mounting stud, and serial number label were replaced due to the back case being replaced due to opening.The unit was tested, and the delivered rate was as expected.The unit was within the tolerance specification.The pump is working as intended.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
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): CARDINAL HEALTH; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 12336425
• MDR Text Key: 267065619
• Report Number: 1282497-2021-10550
• Device Sequence Number: 1
• Product Code: LZH
• UDI-Device Identifier: 10884521006645
• UDI-Public: 10884521006645
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 10/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 383400
• Device Catalogue Number: 383400
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/09/2021
• Patient Sequence Number: 1