MAUDE Adverse Event Report: JABIL SINGAPORE KANGAROO EPUMP - NEW; FEEDING PUMP

Model Number 382400

Device Problems Thermal Decomposition of Device (1071); Material Deformation (2976)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

It was reported to covidien on (b)(6) 2014 that a customer had an issue with a feeding pump.The customer reported the battery burned and service found melted plastic in the battery bay, external signs of melting.

Manufacturer Narrative

Submit date: 10/23/2014.An investigation is currently underway, upon completion, the results will be forwarded.

Manufacturer Narrative

The device history record (dhr) was reviewed indicating that product was released accomplishing all quality standard requirements.There were no non-conforming issues reported during the production of this product for a similar condition as reported in this complaint.One kangaroo epump - new was returned to the service department with a specific request for service/repair: the customer states battery burned.Initial inspection of the unit found that there was no battery received with the pump and that there was melted plastics on and around the battery door, identifying a failure with the unit, therefore this report will be considered confirmed.The unit was escalated to a senior technician who found corrosion on the pcba and bent pins on the battery harness that may have contributed to the battery burning.Another potential cause of the battery burning is the battery wires being pinched between the battery door and the back housing.The kangaroo epump was manufactured in 2013.According to the kangaroo epump ifu, this pump meets es60601-1:2005, ul60601-1 standards with respect to electrical shock, fire and mechanical hazards.To assure the safe and reliable operation of this pumping system, do not attempt to operate without an approved battery pack installed in the pump.Use of a battery pack not supplied by covidien can be dangerous and voids all warranties and performance specifications.A review of the service history records indicates there is one other service history recorded for this system.This information will be utilized for trending purposes to determine the need for corrective action.

• Brand Name: KANGAROO EPUMP - NEW
• Type of Device: FEEDING PUMP
• Manufacturer (Section D): JABIL SINGAPORE; 16 tampines industrial crecsent; singapore ; SN
• Manufacturer (Section G): JABIL SINGAPORE; 16 tampines industrial crecsent; singapore ; SN
• Manufacturer Contact: elaine bishop ; 15 hampshire street; mansfield, MA 02048 ; 5084524686
• MDR Report Key: 4197293
• MDR Text Key: 4979915
• Report Number: 3009247326-2014-00025
• 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: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 382400
• Device Catalogue Number: 382400
• Device Lot Number: C1350030
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/19/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1