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

Model Number 782400

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/14/2016

Event Type  malfunction  

Manufacturer Narrative

An investigation is currently underway.Upon completion, a full report shall be provided.

Event Description

It was reported to covidien on (b)(6) 2016 that the customer experienced an issue with an enteral feeding pump.The customer states: flow volume error occurred.The unit was set to deliver 300ml of formula at a rate of 40ml/h.The unit finished feeding after 4 hours.No patient harm.

Manufacturer Narrative

Submit date: 10/13/2016.An investigation of kangaroo epump was performed for the reported condition of, ¿flow volume error occurred, it was set 300ml of formula as 40ml/h and it finished feeding after 4 hours.¿ the unit was triaged and the complaint was confirmed.The unit was set to deliver 300 ml at a rate of 40 ml/hr; the unit completed feeding after 5 hours and 43 minutes; outside of feeding range.The root cause of the failure was due to the unit¿s gearbox; the gearbox was replaced.Kangaroo epump was manufactured in 2011.A review of the device history record shows this device was released meeting all manufacturing specifications.

• Brand Name: JAPAN KANGAROO EPUMP
• Type of Device: ENTERAL FEEDING PUMP
• Manufacturer (Section D): COVIDIEN; building # 10, 789 puxing road; shanghai ; CH
• Manufacturer (Section G): COVIDIEN; building # 10, 789 puxing road; shanghai ; CH
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 5554844
• MDR Text Key: 42753411
• Report Number: 1282497-2016-00095
• 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: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/28/2016

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 Operator: Other
• Device Model Number: 782400
• Device Catalogue Number: 782400
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/28/2016
• Initial Date FDA Received: 04/07/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1