MAUDE Adverse Event Report: COVIDIEN KANGAROO JOEY,PUMP W/CLMP,REFB; PUMP, INFUSION, ENTERAL

Model Number 383401

Device Problem Thermal Decomposition of Device (1071)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

The customer states reported a non reportable issue with an enteral feeding pump.Upon triage on (b)(6) 2018 service found thermal damage inside the unit.

Manufacturer Narrative

The kangaroo joey pump was returned and evaluated at the regional service center for the reported condition of ¿service found thermal damage inside the unit¿.Upon triage, visual inspection of the interior found components of the pip assembly and main pcba were burned confirming the reported issue which caused damage to both boards and the rear housing.All device history records are reviewed for quality inspections and parameter compliance prior to releasing the product for shipment.Complaint trending information is reviewed on a routine basis and if a trend is observed, actions will be taken as necessary.

• Brand Name: KANGAROO JOEY,PUMP W/CLMP,REFB
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; 15 hampshire st; mansfield MA 02048
• Manufacturer (Section G): COVIDIEN; 15 hampshire street; mansfield MA 02048
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 8021080
• MDR Text Key: 125596047
• Report Number: 1282497-2018-08153
• 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: 11/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 383401
• Device Catalogue Number: 383401
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1