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

Model Number 382400

Device Problems No Display/Image (1183); Device Displays Incorrect Message (2591)

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

Event Type  malfunction  

Manufacturer Narrative

Submit date: 2/17/2017.

Event Description

The customer reported that the unit displays an error code 33.Upon triage the service tech found the unit had a blank display.

Manufacturer Narrative

An evaluation of the kangaroo pump was performed and the customer states ¿during triage, service found the display to be blank.¿ the pump was excessively damaged, so the root cause is categorized as customer misuse.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 - NEW
• Type of Device: ENTERAL FEEDING PUMP
• Manufacturer (Section D): COVIDIEN; 15 hampshire st; mansfield
• Manufacturer (Section G): COVIDIEN; 15 hampshire st; mansfield MA 02048
• Manufacturer Contact: edward almeida ; 15 hampshire st; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 6339860
• MDR Text Key: 68011879
• Report Number: 1282497-2017-00231
• 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: 05/31/2018

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
• Device Lot Number: C14094485
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/10/2017
• Initial Date FDA Received: 02/17/2017
• Supplement Dates Manufacturer Received: 02/10/2017
• Supplement Dates FDA Received: 05/31/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1