MAUDE Adverse Event Report: COVIDIEN KANGAROO JOEY,PUMP W/POLE CLMP; ENTERAL FEEDING PUMP

Model Number 383400

Device Problems Improper Flow or Infusion (2954); Pumping Problem (3016)

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

Event Date 10/12/2016

Event Type  malfunction  

Manufacturer Narrative

Submit date: 11/29/2016.An investigation is currently underway.Upon completion, the results will be forwarded.

Event Description

It was reported to covidien on (b)(6) 2016 that an issue occurred with an enteral feeding pump.The customer reports feeding pump is infusing backwards.Additional information has been requested with no response.If additional pertinent information becomes available, the report will be updated.

Manufacturer Narrative

An evaluation of the kangaroo pump was performed for the reported condition of infusing backwards.The unit was triaged and the reported issue was not confirmed, but found gearbox rotates in both directions.The gearbox issue is caused by a worn clutch which allows the user to manually turn the rotor in reverse.Even with some wear on the clutch it will continue to engage the shaft so that reverse rotation during operation is prevented.Enhancements have been implemented to prevent the reported condition from recurring.All device history records are reviewed for quality inspections and parameter compliance prior to releasing the product for shipment.Post market trending is in place to monitor for further occurrences.If information is provided in the future, a supplemental report will be issued.

• Brand Name: KANGAROO JOEY,PUMP W/POLE CLMP
• Type of Device: ENTERAL FEEDING PUMP
• 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: 6132648
• MDR Text Key: 61354368
• Report Number: 3008361498-2016-00182
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 383400
• Device Catalogue Number: 383400
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/14/2016
• 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