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

Model Number 482400J

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/15/2018

Event Type  malfunction  

Event Description

The customer reports the enteral feeding pump is under delivering.

Manufacturer Narrative

An evaluation of the kangaroo epump was performed.The unit was triaged and the reported issue of "over delivering" could not be confirmed at this time; the unit passed the accuracy test and re-certification.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.

• Brand Name: KANGAROO EPUMP - INTL
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• Manufacturer (Section G): COVIDIEN; 15 hampshire street; mansfield MA 02048
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048
• MDR Report Key: 7855579
• MDR Text Key: 119535327
• Report Number: 1282497-2018-08046
• Device Sequence Number: 1
• Product Code: LZH
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 482400J
• Device Catalogue Number: 482400J
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/21/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1