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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The pump s/n (b)(4) was received and could not be tested to confirm the reported issue due to physical damage.During visual evaluation it was noted that all internal components were damaged.The affected parts were replaced and the pump is functioning as intended.The service history record was reviewed, this device was manufactured in 2012.This is the first time this device has been returned for service.The damaged components were determined to be caused by customer mishandling of the device.Complaint trending information is being reviewed on a monthly basis and if a trend is observed, actions will be taken as necessary.
Event or Problem Description
The customer reported that the pump says stop but, the formula was still flowing.

• 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: 12072950
• Report Number: 1282497-2021-10464
• Device Sequence Number: 3674913
• 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: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/26/2021

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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/19/2020
• Initial Report FDA Received Date: 06/26/2021
• Patient Sequence Number: 1