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

Model Number 382400

Device Problems Failure to Power Up (1476); Device Displays Incorrect Message (2591)

Patient Problem No Information (3190)

Event Date 07/09/2017

Event Type  malfunction  

Event Description

Feeding pump will not turn on.Continue to receive error code "17/125" - code is unknown.Bio med department is unable to repair and pumps need to be sent out.Covidien takes too long to repair so pumps are sent to 3rd party.This issue happened prior to this incident and continues since.Per site reporter: previous incidents where unit is sent to the manufacturer for repair the turnaround time is too long.Hospital has been sending the units out to a third party.

• Brand Name: KANGAROO
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 7009485
• MDR Text Key: 91344517
• Report Number: 7009485
• Device Sequence Number: 1
• Product Code: LZH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2017
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 382400
• Device Catalogue Number: 382400
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/27/2017
• Event Location: Hospital
• Date Report to Manufacturer: 09/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1