MAUDE Adverse Event Report: CARDINAL HEALTH, INC. KANGAROO ENTERAL FEED AND FLUSH PUMP WITH POLE CLAMP; PUMP, INFUSION, ENTERAL

Model Number 382400

Device Problems Device Displays Incorrect Message (2591); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Date 01/24/2022

Event Type  malfunction  

Event Description

Pump1: failed on first attempt to start-up, (b)(4).Pump2: failed primed tubing and rant for 30' but then failed with (b)(4).

• Brand Name: KANGAROO ENTERAL FEED AND FLUSH PUMP WITH POLE CLAMP
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): CARDINAL HEALTH, INC.; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 13558700
• MDR Text Key: 285818350
• Report Number: 13558700
• 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: 02/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2022
• 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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/08/2022
• Event Location: Hospital
• Date Report to Manufacturer: 02/18/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1