MAUDE Adverse Event Report: COVIDIEN INT KANGAROO EPUMP X1; ENTERAL FEEDING PUMP

Model Number 482400J

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.

Event Description

It was reported to covidien on (b)(6) 2017 that an issue occurred with an enteral feeding pump.The customer reports the unit failed the buzzer test.No patient involvement.

Manufacturer Narrative

An evaluation of the kangaroo pump was performed for the reported condition of, ¿pump ¿ no audible alarm.¿ the unit was triaged and the customer¿s reported condition was confirmed.A trend has been identified and a capa has been opened to address this issue.A review of the device history record shows that this unit was manufactured in 2016 and was released meeting all manufacturing specifications.If information is provided in the future, a supplemental report will be issued.

• Brand Name: INT KANGAROO EPUMP X1
• Type of Device: ENTERAL FEEDING PUMP
• Manufacturer (Section D): COVIDIEN; 15 hampshire st; mansfield MA 02048
• Manufacturer (Section G): COVIDIEN; 15 hampshire st; mansfield MA 02048
• Manufacturer Contact: edward almeida ; 15 hampshire st; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 6296925
• MDR Text Key: 66680400
• Report Number: 1282497-2017-00187
• 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: 01/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 482400J
• Device Catalogue Number: 482400J
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/18/2017
• 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