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

Model Number	382400
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/06/2021
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 device was overfeeding.Additional information was received stating that the issue occurred during testing.The volume to be infused was set to 75ml and the rate was set to 150ml/hr., however, the actual volume delivered was 85ml.The test was completed in 30 minutes.They used distilled water for testing.
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.After review, it was determined that the gearbox was worn.The software was updated.The back housing, sensor, and battery were replaced.The hinge label, tyvek vent, serial number label, and vinyl foot were replaced due to back housing replacement.The pump was tested, and the problem was resolved.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: 12138190
• Report Number: 1282497-2021-10481
• Device Sequence Number: 11170668
• Product Code: LZH
• UDI-Device Identifier: 10884521006614
• UDI-Public: 10884521006614
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 10/19/2021

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
• Operator of Device: No Information
• Device Model Number: 382400
• Device Catalogue Number: 382400
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/06/2021
• Supplement Date Received by Manufacturer: 07/06/2021
• Initial Report FDA Received Date: 07/08/2021
• Supplement Report FDA Received Date: 10/19/2021
• Patient Sequence Number: 1