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

Model Number 382400

Device Problems Failure to Power Up (1476); Device Displays Incorrect Message (2591)

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

Event Date 05/17/2020

Event Type  malfunction  

Event Description

(b)(4) kangaroo pump screen showed system error while running continuous feeds.Pump turned off and restarted.Pump showed system error again approx 6 hours later.(b)(4).Kangaroo pump not turning on.Pump was plugged in supply room prior to bringing it into pt's room where it was plugged in again.Green light on charging block illuminated when plugged in.

• Brand Name: KANGAROO
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): CARDINAL HEALTH, INC.; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 10127829
• MDR Text Key: 194358704
• Report Number: 10127829
• 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: 06/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2020
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 382400
• Device Catalogue Number: 382400
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/02/2020
• Event Location: Hospital
• Date Report to Manufacturer: 06/08/2020
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 5475 DA