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

Model Number	482400J
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident device has been requested but to date has not been received for evaluation.If the device is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.
Event or Problem Description
The customer reported that the feed rate too high.The volume output was significantly higher than the specified.
Additional Manufacturer Narrative
H3 evaluation summary no service history is available for the reported unit as this is the first time this unit has been returned to the service center for service.An accuracy flow rate test was performed at room temperature.A new pump set bag was filled with water to the 500 ml mark.The pump set was loaded into the pump with the distance between the bottom of the bag above the pump by 18 inches.The pump was run on a/c power at rate of 150ml/hr for 15 min to achieve a steady state of operation.The water was collected in a calibrated measuring container for 30 minutes.The amount of water collected was within the acceptable range.The pump did not fail the accuracy flow rate test.The service tech could not find any problem with the accuracy of the flow rate of this pump.A corrective and preventative action (capa) is not applicable since the reported event could not be confirmed through the evaluation of the returned device.This complaint will be used for tracking and trending purposes.

• Brand Name: KANGAROO EPUMP - INTL
• Common Device Name: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• Manufacturer (Section G): COVIDIEN; 15 hampshire street; mansfield MA 02048
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 11925821
• Report Number: 1282497-2021-10234
• Device Sequence Number: 4396018
• Product Code: LZH
• UDI-Device Identifier: 10884521174818
• UDI-Public: 10884521174818
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 11/19/2021

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 Model Number: 482400J
• Device Catalogue Number: 482400J
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/26/2021
• Supplement Date Received by Manufacturer: 05/26/2021
• Initial Report FDA Received Date: 06/02/2021
• Supplement Report FDA Received Date: 11/19/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown