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

Model Number 782400

Device Problem Inaccurate Flow Rate (1249)

Patient Problem Feeding Problem (1850)

Event Date 04/01/2021

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 feeding was performed at a feed rate setting (50 ml/h) but, about 80 ml was delivered in one hour.And the total feed was shown as more than the actual (loaded) feed.The product was used on the patient.

Manufacturer Narrative

Investigation summary: the customer reported the feeding was performed at a feed rate setting of 50 ml/hr, however, about 80 ml/hr was delivered.The total feed was shown as more than the actual loaded feed.The product was used on the patient, however, no injury/harm was reported.The reported serialized device was returned for evaluation.Visual inspection did not identify any damage.Functional evaluation determined the device met specification and all tests run passed.No fault was found; therefore, the reported complaint is not confirmed.Additional action will not be taken at this time.This complaint will be used for tracking and trending purposes.

• Brand Name: JAPAN KANGAROO EPUMP
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 11666279
• MDR Text Key: 245552189
• Report Number: 1282497-2021-10054
• Device Sequence Number: 1
• Product Code: LZH
• 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: 06/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 782400
• Device Catalogue Number: 782400
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/05/2021
• Patient Sequence Number: 1