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

Model Number	482400J
Medical Device Problem Code	Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/01/2018
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 reported that the unit's pump not delivering the accurate amount.The volume to be infused was set to 250ml and the rate was set to 110ml/hr.The actual volume delivered was 200ml.The feed was completed in 2 hours.
Additional Manufacturer Narrative
An evaluation of the kangaroo pump was performed and the customer states ¿the unit's pump is not delivering the accurate amount.¿ the unit was triaged and the reported issue could not be confirmed at this time.A review of the device history record shows that this unit was manufactured in 2013 and was released meeting all manufacturing specifications.Complaint trending information is being reviewed on a monthly basis and if a trend is observed, actions will be taken as necessary.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 street; mansfield MA 02048
• MDR Report Key: 7406675
• Report Number: 1282497-2018-00259
• Device Sequence Number: 11029743
• Product Code: LZH
• UDI-Device Identifier: 10884521174818
• UDI-Public: 10884521174818
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2018

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: Health Professional
• Device Model Number: 482400J
• Device Catalogue Number: 482400J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2018
• Initial Date Received by Manufacturer: 03/06/2018
• Supplement Date Received by Manufacturer: 03/06/2018
• Initial Report FDA Received Date: 04/09/2018
• Supplement Report FDA Received Date: 05/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1