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

Model Number 383400

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/07/2021

Event Type  malfunction  

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 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.

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
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 12454505
• MDR Text Key: 271067878
• Report Number: 1282497-2021-10606
• Device Sequence Number: 1
• Product Code: LZH
• UDI-Device Identifier: 10884521006645
• UDI-Public: 10884521006645
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 383400
• Device Catalogue Number: 383400
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/08/2021
• Patient Sequence Number: 1