MAUDE Adverse Event Report: CARDINAL HEALTH, INC. KANGAROO; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 711006CN

Device Problem Flushing Problem (1252)

Patient Problem Insufficient Information (4580)

Event Date 11/19/2020

Event Type  malfunction  

Event Description

Four different kangaroo¿ co2 detectors were placed on the same patient over the course of two days.There was constant difficulty when flushing them or unable to flush them at all.New kangaroo¿ co2 detector was opened to replaced the defective ones and the same problem was occurred with the new device.X-ray showed that the kangaroo¿ co2 detector was in proper position even when pulled back a little.After the failure of the 4th kangaroo¿ co2 detector, a nasogastric tube was placed on the patient and able to start tube feeding.

• Brand Name: KANGAROO
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): CARDINAL HEALTH, INC.; 444 mcdonnell blvd.; hazelwood MO 63042
• MDR Report Key: 11169703
• MDR Text Key: 226784660
• Report Number: 11169703
• Device Sequence Number: 1
• Product Code: KNT
• 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: 01/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 711006CN
• Device Catalogue Number: 711006CN
• Device Lot Number: 200970201
• 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: 01/04/2021
• Date Report to Manufacturer: 01/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 27740 DA