MAUDE Adverse Event Report: COVIDIEN KANGAROO; PUMP, INFUSION

Model Number	392455
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Submit date: 9/7/2017.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The customer states that the enteral feeding pump was working for an hour but then it stopped.The error message was indecipherable.There was no patient involvement.
Additional Manufacturer Narrative
An evaluation of the kangaroo pump was performed for the reported condition of, ¿working for an hour then it stopped¿.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 2012 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
• Manufacturer (Section D): COVIDIEN; 789 puxing rd; building 10; shanghai 20111 4; CN 201114
• MDR Report Key: 6848834
• Report Number: 3006451981-2017-05578
• Device Sequence Number: 10926782
• Product Code: FRN
• UDI-Device Identifier: 10884521006652
• UDI-Public: 10884521006652
• 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): 12/01/2017

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 Expiration Date: 12/19/2022
• Device Model Number: 392455
• Device Catalogue Number: 392455
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2017
• Initial Date Received by Manufacturer: 08/15/2017
• Supplement Date Received by Manufacturer: 10/26/2017
• Initial Report FDA Received Date: 09/07/2017
• Supplement Report FDA Received Date: 12/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1