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

Model Number 383400

Device Problem Insufficient Information (3190)

Patient Problem Death (1802)

Event Date 06/30/2016

Event Type  Death  

Manufacturer Narrative

Submit date: 08/02/2016.An investigation is currently underway.Upon completion, a full report shall be provided.

Event Description

It was reported to covidien on 07/25/2016 that a patient died.The patient died when they had an enteral feeding pump in their possession.It is unknown if the unit was in use when the patient expired.Per the customer, there is no belief that the unit had any involvement with the patient's death.

Manufacturer Narrative

To date, the unit has not been received for evaluation.Without the unit, a detailed investigation could not be performed and the reported condition could not be confirmed.This complaint file shall be closed as unconfirmed at this time.If the unit is returned, the complaint shall be re-opened.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 routine basis and if a trend is observed, actions will be taken as necessary.This information will be utilized for tracking and trending purposes.A good faith effort will be made to obtain the applicable information relevant to the report.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 street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 5840304
• MDR Text Key: 50945836
• Report Number: 3008361498-2016-00036
• 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: 10/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 383400
• Device Catalogue Number: 383400
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/25/2016
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Outcome(s): Death