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 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.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 enteral feeding pump overfilled.Additional information provided and stated that the pump was not in use with a patient at the time of the failure.The pump over delivered in the designated testing time during routine testing.No further information was provided.
Additional Manufacturer Narrative
The service history was reviewed.The reported condition was not confirmed.When assessing the unit, the following issues were detected/serviced and replaced: flash chip, gasket, tie, overlay, pcb board, housing damage, lens, battery door, prin door, serial number label and lcd display.However, despite the worn parts, the device was found to be functional during evaluation.

• 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: 11805988
• Report Number: 1282497-2021-10168
• Device Sequence Number: 14383101
• Product Code: LZH
• UDI-Device Identifier: 10884521144019
• UDI-Public: 10884521144019
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 10/18/2021

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: 04/28/2021
• Supplement Date Received by Manufacturer: 04/28/2021
• Initial Report FDA Received Date: 05/11/2021
• Supplement Report FDA Received Date: 10/18/2021
• Patient Sequence Number: 1