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

Model Number	382401
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/08/2019
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 while in use, the device continued to run and did not shut off when the set amount of feeding was reached.There was no harm to the patient.
Additional Manufacturer Narrative
H 3: evaluation summary: all device history records (dhr) are reviewed for quality inspections and parameter compliance prior to releasing the product for shipment.Complaint trending information is reviewed on a routine basis and if a trend is observed, actions will be taken as necessary.An evaluation was performed for the customer reported issue.The device from this complaint was returned and evaluated at the regional service center.The reported condition was confirmed and fixed by replacing the damaged ultrasound sensor (us).The possible root cause of damaged to the us could not be determined at this time.As no root cause could be determined based on the available information; no actions will be taken at this time.This complaint will be used for tracking and trending purposes.

• Brand Name: KANGAROO EPUMP - RFB
• Common Device Name: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 9172086
• Report Number: 1282497-2019-08707
• Device Sequence Number: 2402128
• Product Code: LZH
• UDI-Device Identifier: 10884521006621
• UDI-Public: 10884521006621
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 01/03/2020

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: 382401
• Device Catalogue Number: 382401
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/08/2019
• Supplement Date Received by Manufacturer: 10/08/2019
• Initial Report FDA Received Date: 10/09/2019
• Supplement Report FDA Received Date: 01/03/2020
• Patient Sequence Number: 1