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

Model Number 382401

Device Problems Failure of Device to Self-Test (2937); Mechanics Altered (2984); Naturally Worn (2988); Noise, Audible (3273)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Submit date: 01/03/2016.An investigation is currently underway.Upon completion the results will be forwarded.

Event Description

It was reported to covidien on (b)(6) 2016 that a customer had an issue with an epump.The customer states the unit failed auto test.The repair record states: upon initial inspection the rotor shaft of the gearbox assembly (p/n: f31881) made a grinding sound when manually rotated.It would sometimes lock up when manually rotated.The cause of the grinding sound was a worn rotor shaft and clutch.

Manufacturer Narrative

The unit was triaged and the customer¿s reported condition was confirmed.Design enhancements were put in place in to enhance the st rength of the shaft material.All device history records are reviewed for quality inspections and parameter compliance prior to releasing the product for shipment.Complaint trending information is being reviewed on a monthly basis and if a trend is observed, actions will be taken as necessary.If information is provided in the future, a supplemental report will be issued.

• Brand Name: KANGAROO EPUMP - RFB
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; 2824 airwest boulevard; plainfield IN 46168
• Manufacturer (Section G): COVIDIEN; 2824 airwest boulevard; plainfield IN 46168
• Manufacturer Contact: edward almeida ; 15 hampshire st; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 6218055
• MDR Text Key: 63956458
• Report Number: 3008361498-2017-00003
• 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: health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2017
• 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
• Device Lot Number: C0820258
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1