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

Model Number	382400
Medical Device Problem Code	Inaccurate Delivery (2339)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2021
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 was feeding too fast.Additional information was received and stated that the patient was not overfed.
Additional Manufacturer Narrative
H3 evaluation summary: the service history record was reviewed and indicated that this is the first time that this unit has been returned for service.An evaluation of the kangaroo pump was performed.The unit was triaged, and the reported issue was confirmed.The battery was found to be damaged and was replaced.The gearbox was found to be damaged and was running both ways.The gearbox was also replaced.The reported problem was resolved.The software was updated to the most currant version.The us sensor was broken, and the back housing was broken on the pole clamp area.The power connection label was replaced due to the unit being opened.The bump, hinge label, vinyl foot, tyvek vent, and serial number label was replaced due to the back housing being replaced.The pump is working as intended.No further actions are required at this time.Complaint trending information is being reviewed on a monthly basis and if a trend is observed, actions will be taken as necessary.

• Brand Name: KANGAROO EPUMP - NEW
• Common Device Name: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 11645266
• Report Number: 1282497-2021-10046
• Device Sequence Number: 3052701
• Product Code: LZH
• UDI-Device Identifier: 10884521143876
• UDI-Public: 10884521143876
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2021

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: 04/07/2021
• Supplement Date Received by Manufacturer: 04/07/2021
• Initial Report FDA Received Date: 04/09/2021
• Supplement Report FDA Received Date: 10/20/2021
• Patient Sequence Number: 1