MAUDE Adverse Event Report: COVIDIEN KANGAROO JOEYPUMP W/POLE CLMP; PUMP, INFUSION, ENTERAL

Model Number	383400
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/07/2021
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.
Event or Problem Description
The customer reported that the device flow was not conforming.Additional information was received that the device flowed faster than the set rate during reconditioning testing.
Additional Manufacturer Narrative
H3 evaluation summary: the service history record was reviewed.The unit was 100% functional at the time of last release after preventative maintenance.The customer reported the flow is not conforming.The reported issue was able to be duplicated.The unit was inspected and tested.A keypad failure was found.The reported condition was confirmed.The overlay and the printed circuit board (pcb) assembly was replaced.Complaint trend analysis (cta) will be performed and reviewed by the capa trending review board to further evaluate requirements for corrective and preventative action (capa) escalation as improvement activities and inputs to management review.

• Brand Name: KANGAROO JOEYPUMP W/POLE CLMP
• Common Device Name: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 12454505
• Report Number: 1282497-2021-10606
• Device Sequence Number: 4067118
• Product Code: LZH
• UDI-Device Identifier: 10884521006645
• UDI-Public: 10884521006645
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2021

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: 383400
• Device Catalogue Number: 383400
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/08/2021
• Supplement Date Received by Manufacturer: 09/08/2021
• Initial Report FDA Received Date: 09/10/2021
• Supplement Report FDA Received Date: 10/13/2021
• Patient Sequence Number: 1