MAUDE Adverse Event Report: COVIDIEN JAPAN KANGAROO EPUMP; PUMP, INFUSION, ENTERAL

Model Number 782400

Device Problem Excess Flow or Over-Infusion (1311)

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

Event Date 08/18/2021

Event Type  malfunction  

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.

Event Description

The customer reported that the pump was letting the volume almost twice as much as what was set to flow.

Manufacturer Narrative

An evaluation of the kangaroo pump was performed and the customer states, ¿pump was letting the volume almost twice as much as what was set to flow".The unit was triaged and the reported issue was confirmed due to a gearbox failure.The gearbox was replaced.The ultrasound sensor and battery were also replaced due to deterioration (ultrasound sensor) and expiration (battery).Complaint trending information is being reviewed on a monthly basis and if a trend is observed, actions will be taken as necessary.Complaint trend analysis (cta) will be performed and reviewed by corrective action and preventative action (capa) trending review board to further evaluate requirements for capa escalation as an improvement activities and inputs to management review.

• Brand Name: JAPAN KANGAROO EPUMP
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• Manufacturer (Section G): COVIDIEN; 15 hampshire street; mansfield MA 02048
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 12378293
• MDR Text Key: 268496628
• Report Number: 1282497-2021-10576
• Device Sequence Number: 1
• Product Code: LZH
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 12/08/2021

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
• Device Model Number: 782400
• Device Catalogue Number: 782400
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/18/2021
• Initial Date FDA Received: 08/27/2021
• Supplement Dates Manufacturer Received: 08/18/2021
• Supplement Dates FDA Received: 12/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: A
• Patient Sequence Number: 1