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

Model Number 775100

Device Problem Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/16/2019

Event Type  malfunction  

Event Description

Tubing was leaking.It was spiked correctly by a seasoned rn.She states that this has happened at least four times in the past two months.Tubing is leaking from beneath the part that spikes the feeding bag (not from where the bag is spiked in).

• Brand Name: KANGAROO
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): CARDINAL HEALTH, INC.; 300 south riverside plaza; suite 2010; chicago IL 60606
• MDR Report Key: 8869037
• MDR Text Key: 153531966
• Report Number: 8869037
• Device Sequence Number: 1
• Product Code: LZH
• UDI-Device Identifier: 10884521155817
• UDI-Public: (01)10884521155817
• 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: 07/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 775100
• Device Catalogue Number: 775100
• Device Lot Number: 190250065
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/31/2019
• Event Location: Hospital
• Date Report to Manufacturer: 08/07/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/07/2019
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 23360 DA