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

Model Number 382400

Device Problems No Device Output (1435); Device Displays Incorrect Message (2591)

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

Event Type  malfunction  

Manufacturer Narrative

Submit date: 12/13/2016.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 states the unit displays an error 33.Upon triage on (b)(6) 2016 the service tech found the unit had no audio.

Manufacturer Narrative

An evaluation of the kangaroo epump was performed for the reported condition of, ¿service technician finding of no audio during triage¿.It was noted that the pump had liquid ingress, a capacitor was missing, a piece of the pcb was burnt, and there was a dislodged operational chip.A trend has been identified and a corrective action has been opened to address this issue.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 EPUMP - NEW
• Type of Device: ENTERAL FEEDING PUMP
• Manufacturer (Section D): COVIDIEN; building # 10, 789 puxing road; shanghai ; CH
• MDR Report Key: 6171778
• MDR Text Key: 62613535
• Report Number: 3006451981-2016-00681
• Device Sequence Number: 1
• Product Code: LZH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 382400
• Device Catalogue Number: 382400
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/06/2016
• Initial Date FDA Received: 12/13/2016
• Supplement Dates Manufacturer Received: 12/06/2016; 08/08/2018
• Supplement Dates FDA Received: 08/06/2018; 10/03/2018
• Patient Sequence Number: 1