MAUDE Adverse Event Report: COVIDIEN MFG PLAINFIELD KANGAROO; PUMP, INFUSION, ENTERAL

Model Number 382401

Device Problem Device Stops Intermittently (1599)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Submit date: 2017-06-28.

Event Description

The customer unit was returned for routine maintenance.Upon triage, the unit shut off and had intermittent power during the recertification test.No patient injury reported.

Manufacturer Narrative

An evaluation of the kangaroo pump was performed for the reported condition of shut off and had intermittent power during recertification test.The unit was triaged and the reported issue was confirmed.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
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN MFG PLAINFIELD; 2824 airwest blvd; plainfield IN 46168
• Manufacturer (Section G): COVIDIEN MFG PLAINFIELD; 2824 airwest blvd; plainfield IN 46168
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 6672959
• MDR Text Key: 78576697
• Report Number: 3008361498-2017-05236
• Device Sequence Number: 1
• Product Code: LZH
• UDI-Device Identifier: 10884521006621
• UDI-Public: 10884521006621
• 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: 11/08/2017

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: 382401
• Device Catalogue Number: 382401
• Device Lot Number: C0716237
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/02/2017
• Initial Date FDA Received: 06/28/2017
• Supplement Dates Manufacturer Received: 10/19/2017
• Supplement Dates FDA Received: 11/08/2017
• 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