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

Model Number	482400J
Medical Device Problem Code	Inaccurate Delivery (2339)
Health Effect - Clinical Code	Vomiting (2144)
Date of Event	06/13/2020
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 on saturday, (b)(6) 2020 the patient was having a feed via an epump.The pump reads at 0400 and then at 0500 and within the hour, 300 ml had gone through instead of 80 ml.The patient vomited as a consequence.
Additional Manufacturer Narrative
An evaluation of the kangaroo epump was performed.The reported issue was confirmed and corrected by replacing the failed gear box.In addition, the overlay has been replaced, the firmware has been updated and the factory settings have been restored.Functional and safety test have been completed according to procedure.The unit passed both functional testing and testing on electric safety.All device history records are reviewed for quality inspections and parameter compliance prior to releasing the product for shipment.Complaint trending information is being reviewed on a monthly basis and if a trend is observed, actions will be taken as necessary.This information will be utilized for tracking and trending purposes.
Additional Manufacturer Narrative
Additional information: d4 serial number added.

• Brand Name: KANGAROO EPUMP - INTL
• Common Device Name: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 10220640
• Report Number: 1282497-2020-09173
• Device Sequence Number: 2095165
• Product Code: LZH
• UDI-Device Identifier: 10884521174818
• UDI-Public: 10884521174818
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/27/2020

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: 482400J
• Device Catalogue Number: 482400J
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/25/2020
• Supplement Date Received by Manufacturer: 06/25/2020; 06/25/2020
• Initial Report FDA Received Date: 07/01/2020
• Supplement Report FDA Received Date: 07/06/2020; 08/27/2020
• Patient Sequence Number: 1