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

Model Number 383400

Device Problems No Audible Alarm (1019); Device Displays Incorrect Message (2591)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 07/10/2018

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

The customer reported the feeding pump failed the rotor error alarm test.The event was discovered during testing.There is no reported patient involvement.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

An evaluation of the kangaroo joey pump was performed and the customer states, ¿pump failed the rotor error alarm test.¿ the unit was triaged and the customer¿s reported condition was confirmed.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.

• Brand Name: KANGAROO
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• Manufacturer (Section G): COVIDIEN; 15 hampshire street; mansfield MA 02048
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 7731470
• MDR Text Key: 115555445
• Report Number: 1282497-2018-00633
• 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,Followup
• Report Date: 10/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 383400
• Device Catalogue Number: 383400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1