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 08/23/2021

Event Type  malfunction  

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.

Event Description

The customer reported that based on the hospital staff, the flow rate was faster than intended.It was confirmed when the me inspected the device.The total feeding of 200 ml was set at 50 ml/hr and, the feeding was completed in 2 hours or so.There was no patient harm.

Manufacturer Narrative

Investigation conclusion: the customer reported that based on the hospital staff, the flow rate was faster than intended.It was confirmed when the me inspected the device.The total feeding of 200ml was set at 50ml/hr and, the feeding was completed in 2 hours or so.There was no patient harm.No service history record available for the reported durable device as this is the first time the unit was returned for service.The reported durable device was returned for evaluation.Functional testing was unable to confirm the reported device failure.The device met specification with regards to feeding rate.An unrelated device failure, deformed rotor shaft, was identified.The rotor was replaced and the device was returned to the customer.Additional action will not be taken at this time as the reported device failure was not confirmed and/or replicated during testing.This complaint will be used for monitoring and trending purposes.

• 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: 12385315
• MDR Text Key: 268718403
• Report Number: 1282497-2021-10578
• 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,Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 12/14/2021

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: 08/25/2021
• Initial Date FDA Received: 08/30/2021
• Supplement Dates Manufacturer Received: 08/25/2021
• Supplement Dates FDA Received: 12/14/2021
• 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