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

Model Number	482400J
Medical Device Problem Code	Volume Accuracy Problem (1675)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The customer states that the unit's volume accuracy is incorrect.The customer reports the enteral feeding pump was set to infuse 1000ml at 120ml per hour however it took 10-1/2 hours to complete.The customer was using a new 777403 feeding set.No reported injury or medical intervention was required.
Additional Manufacturer Narrative
The service information regarding this unit is not available at this time.If the information becomes available, the applicable service notes will be updated and housed at the local technical service center.All device history records are reviewed for quality inspections and parameter compliance prior to releasing the product for shipment.Complaint trending information is being reviewed on a monthly basis and if a trend is observed, actions will be taken as necessary.This information will be utilized for tracking and trending purposes.If information is provided in the future, a supplemental report will be issued.

• Brand Name: KANGAROO
• Common Device Name: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; 15 hampshire st; mansfield MA 02048
• MDR Report Key: 7807390
• Report Number: 1282497-2018-00675
• Device Sequence Number: 11026103
• Product Code: LZH
• UDI-Device Identifier: 10884521174818
• UDI-Public: 10884521174818
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2019

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
• Operator of Device: Lay User/Patient
• Device Model Number: 482400J
• Device Catalogue Number: 482400J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2018
• Initial Date Received by Manufacturer: 08/17/2018
• Supplement Date Received by Manufacturer: 08/17/2018
• Initial Report FDA Received Date: 08/22/2018
• Supplement Report FDA Received Date: 03/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1