MAUDE Adverse Event Report: COVIDIEN KANGAROO JOEY,PUMP W/CLMP,REFB; PUMP, INFUSION, ENTERAL

Model Number	383401
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2021
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 sometimes the formula will run out before the pump shuts off and then sometimes there's formula left in the bag when the pump shuts off and says complete.There was no harm to the patient.
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 gearbox was found damaged and was replaced.The main door hinge was broken so the back housing was replaced.The reported problem was resolved.The software was updated to the most currant version.The pcb was damaged by corrosion.The us sensor was broken.The lcd display was damaged, and the overlay was lifted.Due to the overlay replacement, the front housing, the spacers, and the lens was replaced.The cover buzzer, harness, mounting stud, tie, serial number label, and foam battery was replaced due to the back housing replacement.Gaskets were replaced due to opening the unit.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 JOEY,PUMP W/CLMP,REFB
• Common Device Name: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 11406416
• Report Number: 1282497-2021-09948
• Device Sequence Number: 11904162
• Product Code: LZH
• UDI-Device Identifier: 10884521144019
• UDI-Public: 10884521144019
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 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: 383401
• Device Catalogue Number: 383401
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/19/2021
• Supplement Date Received by Manufacturer: 02/19/2021
• Initial Report FDA Received Date: 03/03/2021
• Supplement Report FDA Received Date: 10/20/2021
• Patient Sequence Number: 1