MAUDE Adverse Event Report: COVIDIEN KANGAROO EPUMP - NEW

Model Number 382400

Device Problems Loss of Power (1475); Device Stops Intermittently (1599); Device Displays Incorrect Message (2591)

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

Event Type  malfunction  

Manufacturer Narrative

Submit date: 01/03/2016.An investigation is currently underway, upon completion the results will be forwarded.

Event Description

It was reported to covidien on (b)(6) 2016 that a customer had an issue with an epump.The customer states service error and shuts off.The intermittent power makes this reportable.

Manufacturer Narrative

An evaluation of the kangaroo joey pump was performed for the reported condition of the unit is turning on and off.The unit was triaged and the reported issue could not be confirmed at this time.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: EPUMP
• 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: 6218009
• MDR Text Key: 63954663
• Report Number: 3008361498-2017-00002
• 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: health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/22/2016

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: C0731732
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/22/2016
• Initial Date FDA Received: 01/03/2017
• Supplement Dates Manufacturer Received: 07/22/2016
• Supplement Dates FDA Received: 09/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1