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

Model Number 382400

Device Problems Device Alarm System (1012); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

An investigation is currently under way.Upon completion the results will be forwarded.

Event Description

It was reported to covidien on (b)(6) 2016 that a customer had an issue with an enteral feeding pump.The customer initiated a service repair request but did not state a specific issue.Upon triage, the service tech found the unit had no ramp up alarms.

Manufacturer Narrative

An evaluation of the kangaroo pump was performed for the reported condition of no ramp up alarms.The unit was triaged and the reported condition was confirmed.A trend has been identified and a formal corrective and preventative action has been opened to address this issue.All device history records are reviewed for quality inspections and parameter compliance prior to releasing the product for shipment.If information is provided in the future, a supplemental report will be issued.

• Brand Name: KANGAROO EPUMP - NEW
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; 15 hampshire st; mansfield ; SN
• Manufacturer (Section G): COVIDIEN; 15 hampshire st; mansfield MA 02048
• Manufacturer Contact: edward almeida ; 15 hampshire st; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 6167473
• MDR Text Key: 62391788
• Report Number: 1282497-2016-01013
• Device Sequence Number: 1
• Product Code: LZH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/13/2018

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: Health Professional
• Device Model Number: 382400
• Device Catalogue Number: 382400
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/28/2016
• Initial Date FDA Received: 12/12/2016
• Supplement Dates Manufacturer Received: 11/28/2016
• Supplement Dates FDA Received: 08/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1