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

Model Number	382400
Medical Device Problem Code	Inaccurate Flow Rate (1249)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
The customer reported that the device provided inaccurate volume, it was overfeeding.Additional information was received from the customer stating that the rate was set to 54ml/hr.The actual volume delivered was 270ml completed in 3 hours.The feed was set to run for 5 hours.The patient was stable, no medical intervention was provided.The customer was using a nasogastric tube with similac total comfort formula.
Additional Manufacturer Narrative
The service history was reviewed.The unit did undergo a 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assessing the unite, the following issues were detected/serviced: flash chip verification, battery replaced as it was out of date, power connection label damaged due to opening the unit.The overlay on the top unit was replaced as well as other worn pars such as the gearbox, encoder, us sensor, bracket.However, despite the worn parts, the device was functional during evaluation.The unit was tested based on accuracy test using 125ml.And the delivered rate was as expected.Water was used for this test and the unit is within tolerance specification.

• Brand Name: KANGAROO EPUMP - NEW
• Common Device Name: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 12205095
• Report Number: 1282497-2021-10503
• Device Sequence Number: 3397877
• Product Code: LZH
• UDI-Device Identifier: 10884521006614
• UDI-Public: 10884521006614
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2021

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
• Operator of Device: No Information
• Device Model Number: 382400
• Device Catalogue Number: 382400
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/15/2021
• Supplement Date Received by Manufacturer: 07/15/2021
• Initial Report FDA Received Date: 07/21/2021
• Supplement Report FDA Received Date: 10/14/2021
• Patient Sequence Number: 1