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

Model Number DL482400J

Device Problem Free or Unrestricted Flow (2945)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Submit date: 02/15/2016.An investigation is currently underway.Upon completion, a full investigation will be provided.

Event Description

It was reported to covidien on (b)(6) 2016 that the customer experienced a problem with an enteral feeding pump.The customer reports that the pump does not stop feeding once the scheduled volume was delivered.No patient involvement.

Manufacturer Narrative

An investigation of kangaroo epump was performed for the reported condition of; the pump does not stop feed once volume delivered.The unit was triaged and the complaint could not be confirmed.Kangaroo epump was manufactured in 2013.A review of the device history record shows this device was released meeting all manufacturing specifications.

• Brand Name: RFB KANGAROO EPUMP
• Type of Device: ENTERAL FEEDING PUMP
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• Manufacturer (Section G): COVIDIEN; 15 hampshire street; mansfield MA 02048
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 5436884
• MDR Text Key: 38319148
• Report Number: 1282497-2016-00025
• Device Sequence Number: 1
• Product Code: LZH
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 01/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: DL482400J
• Device Catalogue Number: DL482400J
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/17/2016
• 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