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

Model Number 382401

Device Problem Melted (1385)

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

Event Type  malfunction  

Event Description

It was reported to covidien on (b)(4) 2014 that service found the plug of the power adapter showed external signs of melting.It was conveyed that this plug damage (external melting) appears to have been caused by an outside source.The power adapter wasn't damaged and actually still passes triage for use with a new plug.

Manufacturer Narrative

Submit date: 10/17/2014.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 non-specific request for service/repair.Initial inspection of the pump found that the power adapter and plug had melted, identifying a failure with the unit; therefore, this report will be considered confirmed.The pump and power adapter were escalated to a senior repair technician that found the adapter to have arcing on the internal connection between the power adapter power supply and the adapter plug.The plug and power adapter were melted where the two pieces connect which caused the plug prong to become loose in the mold.There was no reported harm to the patient or the clinical staff.The root cause of the power adapter arcing failure can be attributed to a manufacturing issue of the power adapter.An analysis of similar adapter failures has found the z height of the internal ac pins which connect the power supply to the ac input adapter were too short, causing the internal pins to arc.A supplier corrective action had been taken by the supplier in late 2011 to correct the z height.The internal length of the contact spring was changed from 8.0 mm to 8.5 mm and the molder modified the molding tool in (b)(6) 2012 to prevent distortion of the contact springs.Covidien has since changed power supply manufactures.Power adapters are not serviceable items; therefore, the units will be scrapped.There will be no further corrective action.Product kangaroo epump was manufactured in 2010.A review of the service history records indicates there is no 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 - RFB
• 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: 4180878
• MDR Text Key: 5162561
• Report Number: 3009247326-2014-00024
• 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: 10/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 382401
• Device Catalogue Number: 382401
• Device Lot Number: C1053898
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/05/2014
• 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