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

Model Number	383401
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Customer states that the enteral feeding pump's screen goes black.Patient involvement is unknown.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
An evaluation of the kangaroo pump was performed and the customer states ¿the enteral feeding pump's screen goes black and the unit does not run.¿ the unit was triaged and the reported issue could not be confirmed at this time.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.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; 2824 airwest blvd; plainfield IN 46168
• MDR Report Key: 7742631
• Report Number: 3008361498-2018-00401
• Device Sequence Number: 1560571
• Product Code: LZH
• UDI-Device Identifier: 10884521144019
• UDI-Public: 10884521144019
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/12/2018

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 Expiration Date: 11/13/2014
• Device Model Number: 383401
• Device Catalogue Number: 383401
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/23/2018
• Supplement Date Received by Manufacturer: 08/08/2018; 08/16/2018
• Initial Report FDA Received Date: 08/02/2018
• Supplement Report FDA Received Date: 10/02/2018; 10/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1