MAUDE Adverse Event Report: COVIDIEN KANGAROO; PUMP, INFUSION, ENTERAL

Model Number JOEY

Device Problem Excess Flow or Over-Infusion (1311)

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

Event Date 08/19/2022

Event Type  malfunction  

Event Description

The kangaroo joey pump failed to infuse compleat formula properly.The nurse put 360ml of compleat formula in a bag.The pump appears to be working, but the feed is taking too long to infuse based on the set rate.The pump displayed that it had delivered 500ml even though there was only 360ml placed in the bag.The joey cannot provide accurate delivered volumes when infusing compleat formula.Compleat formula is thick and this had been a problem all day and with using multiple joey pumps.

• Brand Name: KANGAROO
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; 2800 airwest blvd, suite 160; plainfield IN 46168
• MDR Report Key: 15852747
• MDR Text Key: 304204330
• Report Number: 15852747
• 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: 08/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: JOEY
• 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: 08/29/2022
• Device Age: 14 YR
• Event Location: Hospital
• Date Report to Manufacturer: 11/23/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 1095 DA
• Patient Sex: Female