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

Model Number 482400S

Device Problems Thermal Decomposition of Device (1071); Failure to Power Up (1476)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Submit date: 10/05/2016.An investigation is currently underway.Upon completion, the results will be forwarded.

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 is charging, but the pump will not power on.No patient involvement.Upon triage on (b)(6) 2016, service found that the battery wire assembly was burned due to liquid infiltration within the unit.

Manufacturer Narrative

Submit date: 10/28/2016.An investigation of kangaroo epump was performed for the reported condition of; the battery wire assembly was burned.The unit was triaged and the complaint was confirmed.The cause of the reported condition was due to liquid infiltration.The unit¿s battery wire was replaced to correct the issue.The unit was fully tested; unit passed all testing.Kangaroo epump was manufactured in 2013.A review of the device history record shows this device was released meeting all manufacturing specifications.

• 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: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 6056827
• MDR Text Key: 58461825
• Report Number: 3006451981-2016-00476
• 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: 10/05/2016

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: No Information
• Device Model Number: 482400S
• Device Catalogue Number: 482400S
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/03/2016
• Initial Date FDA Received: 10/26/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/28/2016
• 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