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

Model Number FICV2100

Device Problems Mechanical Problem (1384); Power Problem (3010)

Patient Problem No Patient Involvement (2645)

Event Date 09/25/2019

Event Type  malfunction  

Manufacturer Narrative

The device has been received.The investigation is not yet complete.A follow-up will be submitted upon completion of device evaluation and investigation results.

Event Description

Reportedly, post repair, the device turns on, does the countdown to shut down and shuts off.Also, when it is plugged in the battery indicator does not come on.There was no patient involvement.No additional information is available.

Manufacturer Narrative

The complaint device was returned for evaluation.Incoming visual inspection found no anomalies.Technical visual inspection found no anomalies.Device evaluation found a mechanical failure in the motor.The epump motor was replaced with a new oem part.The software was set to 4.009.The device was calibrated.The case was checked for damage.The circuit boards were inspected.The alarm, battery, display, keypad, patient side occlusion, rate accuracy, self test/power, upstream occlusion and final visual inspection were all tested and passed.The root cause for the confirmed reported event was determined to be the failed motor due to aging.This type of event will continue to be monitored.

• Brand Name: COVIDIEN KANGAROO EPUMP
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 9213866
• MDR Text Key: 177833952
• Report Number: 3007409280-2019-00050
• Device Sequence Number: 1
• Product Code: LZR
• Combination Product (y/n): N
• PMA/PMN Number: K143263
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 09/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FICV2100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2019
• Date Manufacturer Received: 10/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1