MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC KANGAROO; PUMP, INFUSION, ENTERAL

Model Number 773656

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

Event Date 01/12/2024

Event Type  malfunction  

Event Description

Tubing broke while in operation.

• Brand Name: KANGAROO
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 18893133
• MDR Text Key: 337524842
• Report Number: 18893133
• Device Sequence Number: 1
• Product Code: LZH
• UDI-Device Identifier: 10192253009941
• UDI-Public: (01)10192253009941
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 773656
• Device Catalogue Number: 773656
• Device Lot Number: 2327200200
• 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: 01/17/2024
• Event Location: Hospital
• Date Report to Manufacturer: 03/13/2024
• Type of Device Usage: Unknown
• Patient Sequence Number: 1