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

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/19/2019

Event Type  malfunction  

Event Description

Started tube feedings and 4 hours later the pump alarmed with system error 23.Covidien replaced cosmetic 3m bump-ons (plastic feet the pump sits on) - all tests passed testing inspections, returned to service.

• Brand Name: KANGAROO
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): CARDINAL HEALTH, INC.; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 10017020
• MDR Text Key: 189586380
• Report Number: 10017020
• Device Sequence Number: 1
• Product Code: LZH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/22/2020
• Event Location: Hospital
• Date Report to Manufacturer: 05/01/2020
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 22630 DA