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

Model Number 382400

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 08/09/2021

Event Type  malfunction  

Event Description

Clinical engineering advised that the doors of feeding pumps fall off and disappear.

• Brand Name: KANGAROO EPUMP
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): CARDINAL HEALTH, INC. - COVIDIEN; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 12589773
• MDR Text Key: 275201650
• Report Number: 12589773
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 10/05/2021,09/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 382400
• Device Catalogue Number: 382400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/05/2021
• Event Location: Hospital
• Date Report to Manufacturer: 10/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1