MAUDE Adverse Event Report: COVIDIEN KANGAROO EPUMP - INTERNATIONAL; ENTERAL FEEDING PUMP

Model Number 482400S

Device Problems Mechanical Problem (1384); Device Stops Intermittently (1599); Pumping Problem (3016)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Submit date: 07/25/2016.An investigation is currently under way; 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 enteral feeding pump.The customer reports: pump motor turns intermittently and slow; no patient involved.The customer tested the feeding pump in his biomed shop and found that the motor was running slower than the other pumps.It seemed to have difficulties pumping the feed through.It was discovered during a preventative maintenance.

Manufacturer Narrative

An evaluation of the kangaroo pump was performed for the reported condition of pump motor turns intermittently and slow.The unit was triaged and the reported issue could not be confirmed at this time.A review of the device history record shows that this unit was manufactured in 2011 and was released meeting all manufacturing specifications.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 - INTERNATIONAL
• Type of Device: ENTERAL FEEDING PUMP
• Manufacturer (Section D): COVIDIEN; 15 hampshire st; mansfield MA 02048
• Manufacturer (Section G): COVIDIEN; 15 hampshire st; mansfield MA 02048
• Manufacturer Contact: matthew amaral ; 15 hampshire st; mansfield, MA 02048 ; 2034926373
• MDR Report Key: 5820199
• MDR Text Key: 51114212
• Report Number: 1282497-2016-00556
• Device Sequence Number: 1
• Product Code: LZH
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 482400S
• Device Catalogue Number: 482400S
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1