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

Model Number 382400

Device Problem Inaccurate Delivery (2339)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

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 failed rate accuracy.During testing the device delivered more than 35ml when set for 30ml volume at a 150ml feed rate.

Manufacturer Narrative

An evaluation of the kangaroo pump was performed.The reported issue was confirmed due to sensor damage.The sensor was replaced and the problem was resolved.Additional actions were completed for preventative and cosmetic measures: the power connection label was replaced due to opening the unit, the back and front housings were replaced, the bump, hinge label, vinyl foot, tyvek vent and serial number label were replaced due to replacing the back housing, the badge and overlay were replaced due to the front hosing replacement, the gearbox was lubricated, the ultrasonic plug was broken and replaced.The rotor rollers were not spinning freely and was replaced.The unit was tested and is working as intended.No further actions are required at this time.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 - NEW
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 11777680
• MDR Text Key: 249063097
• Report Number: 1282497-2021-10150
• Device Sequence Number: 1
• Product Code: LZH
• UDI-Device Identifier: 10884521006614
• UDI-Public: 10884521006614
• 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: 10/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2021
• Is this an Adverse Event Report?: No
• 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
• Date Manufacturer Received: 04/12/2021
• Patient Sequence Number: 1