MAUDE Adverse Event Report: COVIDIEN KANGAROO JOEY,PUMP W/CLMP,REFB; PUMP, INFUSION, ENTERAL

Model Number 383401

Device Problem Improper Flow or Infusion (2954)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/02/2019

Event Type  malfunction  

Manufacturer Narrative

The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.

Event Description

The customer reported that the device is continuously feeding causing an over delivery outside of the accuracy limit.

Manufacturer Narrative

Evaluation summary all device history records are reviewed for quality inspections and parameter compliance prior to releasing the product for shipment.The device was returned and evaluated at the regional service center.The device was tested for the reported condition and passed all testing.The reported issue could not be confirmed.A root cause could not be determined based on the device return and no corrective action is necessary at this time.Complaint trending information is reviewed on a routine basis and if a trend is observed, actions will be taken as necessary.

• Brand Name: KANGAROO JOEY,PUMP W/CLMP,REFB
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 9179082
• MDR Text Key: 162469836
• Report Number: 1282497-2019-08710
• Device Sequence Number: 1
• Product Code: LZH
• UDI-Device Identifier: 10884521144019
• UDI-Public: 10884521144019
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 01/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 383401
• Device Catalogue Number: 383401
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/04/2019
• Patient Sequence Number: 1