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

Model Number 482400S

Device Problems Device Alarm System (1012); Loss of Power (1475); Failure to Power Up (1476)

Patient Problem No Patient Involvement (2645)

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 reports that the unit shuts down while running.The unit powered off without an alarm and would not restart.No patient involvement.

Manufacturer Narrative

An evaluation of the kangaroo joey pump was performed for the reported condition of the unit shuts off.The unit was triaged and the reported issue could not be confirmed at this time.All device history records are reviewed for quality inspections and parameter compliance prior to releasing the product for shipment.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: KANGAROO EPUMP - INTERNATIONAL
• 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: thom mcnamara ; 15 hampshire street; mansfield, MA 02048 ; 5084524811
• MDR Report Key: 5779074
• MDR Text Key: 49765507
• Report Number: 1282497-2016-00445
• 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: 06/29/2016

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: 482400S
• Device Catalogue Number: 482400S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/29/2016
• Initial Date FDA Received: 07/08/2016
• Supplement Dates Manufacturer Received: 06/29/2016
• Supplement Dates FDA Received: 09/25/2017
• 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