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 Date 05/06/2021

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 was over feeding.There was no patient involvement.Additional information was received stating that the feed rate was set to 75ml/hr and after 30 minutes it pumped almost 45ml.

Manufacturer Narrative

An evaluation of the kangaroo pump was performed.The unit was triaged and the reported issue was confirmed.After review, it was determined that the ultrasonic sensor was damaged.Additionally, the software was updated.The battery was found to be obsolete and was replaced.The tyvek vent, hinge, bump and vinyl were missing.All were replaced.The power connection label was replaced as well due to opening the unit.The pump was tested and the problem was resolved.The pump 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: 11826257
• MDR Text Key: 250658779
• Report Number: 1282497-2021-10193
• Device Sequence Number: 1
• Product Code: LZH
• UDI-Device Identifier: 10884521143876
• UDI-Public: 10884521143876
• 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: 10/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2021
• 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: 05/06/2021
• Patient Sequence Number: 1