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

Model Number	383401
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident unit has been requested but to date has not been received for evaluation.If the unit 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 infusion rate changes.Additional information was received stating that there was a patient involved but there was no patient harm or medical intervention required.The infusion times are different each night.Some nights, it pumps too fast, other times it is too slow.The device was switched out.The rn thinks it needs to be recalibrated.The patient was possibly overfed and underfed.Pediasure sidekick was the formula used to feed the patient via mic-key delivery.
Additional Manufacturer Narrative
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determined that the pcb was damaged; j5 had lifted pads.In addition to replacing the pcb, the software was updated, the out-of-date battery and the damaged main door were replaced, and the gaskets and tie were replaced due to opening the unit.The pump was tested, and the problem was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 JOEY,PUMP W/CLMP,REFB
• Common Device Name: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 11379360
• Report Number: 1282497-2021-09935
• Device Sequence Number: 3712229
• 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
• 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: 02/19/2021
• Supplement Date Received by Manufacturer: 02/19/2021
• Initial Report FDA Received Date: 02/25/2021
• Supplement Report FDA Received Date: 10/18/2021
• Patient Sequence Number: 1