MAUDE Adverse Event Report: COVIDIEN INT'L KANGAROO PUMP; ENTERAL FEEDING PUMP

Model Number 482400

Device Problems Display Difficult to Read (1181); Device Stops Intermittently (1599); Defective Component (2292)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Submit date: 1/28/17.An investigation is currently under way.Upon completion the results will be forwarded.

Event Description

It was reported to covidien on (b)(6) 2017 that a customer had an issue with an enteral feeding pump.The customer states that the lcd is defective and the display intermittently goes unreadable.There was no patient involved.

Manufacturer Narrative

An evaluation of the kangaroo pump was performed for the reported condition of display intermittently goes unreadable.The unit was triaged and the customer¿s reported condition was confirmed.The potential root causes are the use of an unauthorized power adapter by the user and a possibly defective component.A review of the device history record shows that this unit was manufactured in 2007 and was released meeting all manufacturing specifications.Complaint trending information is being reviewed on a monthly basis and if a trend is observed, actions will be taken as necessary.If information is provided in the future, a supplemental report will be issued.

• Brand Name: INT'L KANGAROO PUMP
• Type of Device: ENTERAL FEEDING PUMP
• Manufacturer (Section D): COVIDIEN; 2824 airwest boulevard; plainfield IN 46168
• Manufacturer (Section G): COVIDIEN; 2824 airwest boulevard; plainfield IN 46168
• Manufacturer Contact: edward almeida ; 15 hampshire st; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 6287441
• MDR Text Key: 66355730
• Report Number: 3008361498-2017-00090
• 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: 10/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 482400
• Device Catalogue Number: 482400
• Device Lot Number: C0722118
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1