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

Model Number	382401
Medical Device Problem Code	Device Stops Intermittently (1599)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Submit date: 2017-06-28.
Event or Problem Description
The customer unit was returned for routine maintenance.Upon triage, the unit shut off and had intermittent power during the recertification test.No patient injury reported.
Additional Manufacturer Narrative
An evaluation of the kangaroo pump was performed for the reported condition of shut off and had intermittent power during recertification test.The unit was triaged and the reported issue was confirmed.The pump was excessively damaged, so the root cause is categorized as customer misuse.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 MFG PLAINFIELD; 2824 airwest blvd; plainfield IN 46168
• MDR Report Key: 6672959
• Report Number: 3008361498-2017-05236
• Device Sequence Number: 72159
• Product Code: LZH
• UDI-Device Identifier: 10884521006621
• UDI-Public: 10884521006621
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Report Date (Section B): 11/08/2017

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: 382401
• Device Catalogue Number: 382401
• Device Lot Number: C0716237
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2017
• Initial Date Received by Manufacturer: 06/02/2017
• Supplement Date Received by Manufacturer: 10/19/2017
• Initial Report FDA Received Date: 06/28/2017
• Supplement Report FDA Received Date: 11/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1