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
The service history was reviewed and indicated that this is the first time that his unit has been returned to the service center for service.The kangaroo epump was evaluated and the reported issue could not be confirmed.An accuracy flow rate test was performed at room temperature (23° c).A new feed-only pump set bag was filled with water to the 500ml mark and the pump set was loaded.The distance between the bottom of the bag above the pump was 18 inches.The pump was ran on a/c power at a rate of 150ml/hr for 15 minutes to achieve a steady state of operation.The water was then collected in a calibrated measuring container for 30 minutes.The amount of water collected in 30 minutes was 71ml which is in the acceptable range of 67.5ml and 82.5ml.The pump passed the accuracy flow rate test and no other issues were observed.The engineer then confirmed with the customer that they did not follow the test procedure outlined in the operation manual.As a result, the root cause of the issue reported was determined to be user error.A corrective action is not applicable at this time.Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.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: 11925453
• Report Number: 1282497-2021-10233
• Device Sequence Number: 19932376
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2022

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): Initial
• 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: 04/04/2022
• 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