MAUDE Adverse Event Report: CARDINAL HEALTH, INC. KANGAROO EPUMP ENTERAL FEED; PUMP, INFUSION, ENTERAL

Model Number 382400

Device Problems Improper Flow or Infusion (2954); Program or Algorithm Execution Problem (4033)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/15/2022

Event Type  malfunction  

Event Description

Upon inspection of the kangaroo pump, it was noted that the programmed continuous feeds were set at a rate of 55cc/hr.The free water fluids programmed into the pump were set for 150cc every 4 hours.The hourly pump history did correctly reflect the continuous infusion but the flush history revealed that no free water flushes were administered automatically by the pump.

• Brand Name: KANGAROO EPUMP ENTERAL FEED
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): CARDINAL HEALTH, INC.; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 15484800
• MDR Text Key: 300564377
• Report Number: 15484800
• Device Sequence Number: 1
• Product Code: LZH
• UDI-Device Identifier: 10884521006614
• UDI-Public: (01)10884521006614
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 382400
• Device Catalogue Number: 382400
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/15/2022
• Event Location: Hospital
• Date Report to Manufacturer: 09/26/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 31390 DA
• Patient Sex: Male
• Patient Weight: 75 KG