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 rate of the pump was out of range.During preventative maintenance, the volume was over the 82.4ml limit when the device was set to continuous mode of 150ml/hr.For the 30 minutes accuracy test.

Manufacturer Narrative

The service history was reviewed.The unit did undergo a standard repair in the past two years however it was not associated with the current reported condition stated as overfeeding.The condition was not confirmed.When assessing the unit, the following issues were detected/serviced and replaced: flash chip, rotor damage, outdated battery pcb corrosion, sensor damage, housing damage hinge replaced, power connection label, vinyl foot, tyvek vent, serial number label.However, despite the worn parts, the device was found to be functional during evaluation.

• Brand Name: KANGAROO EPUMP - NEW
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 11697206
• MDR Text Key: 246440332
• Report Number: 1282497-2021-10081
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 10/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 04/01/2021
• Initial Date FDA Received: 04/20/2021
• Supplement Dates Manufacturer Received: 04/01/2021
• Supplement Dates FDA Received: 10/18/2021
• Patient Sequence Number: 1