MAUDE Adverse Event Report: COVIDIEN KANGAROO; PUMP, INFUSION, ENTERAL

Model Number 382401

Device Problems No Audible Alarm (1019); Thermal Decomposition of Device (1071); Melted (1385)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

A specific issue was not stated on this back to stock unit.Upon triage on (b)(6) 2018 the service tech found the unit had no post alarms.Upon initial investigation on (b)(6) 2018 the investigator found the unit had a burnt and melted component.

Manufacturer Narrative

An evaluation of the kangaroo pump was performed for the reported condition of, ¿a specific issue was not stated on this back to stock unit.Upon triage on (b)(6) 2018 the service tech found the unit had no post alarms.Upon initial investigation on 07/17/2018 the investigator found the unit had a burnt and melted component.¿ the unit was triaged and the reported conditions were confirmed.For the no audible alarm issue, a trend has been identified and a corrective action has been opened to address this issue.For the thermal issue, liquid ingress caused corrosion, and is the result of customer misuse.All device history records are reviewed for quality inspections and parameter compliance prior to releasing the product for shipment.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: KANGAROO
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; 2824 airwest blvd; plainfield IN 46168
• Manufacturer (Section G): COVIDIEN; 2824 airwest blvd; plainfield IN 46168
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 7746293
• MDR Text Key: 116089307
• Report Number: 3008361498-2018-00400
• 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,Followup
• Report Date: 10/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 382401
• Device Catalogue Number: 382401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/08/2018
• 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