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

Model Number 382400

Device Problems No Audible Alarm (1019); Appropriate Term/Code Not Available (3191)

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

Event Date 05/30/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer did not report any specific complaint.On (b)(6) 2018, the unit was triaged and service found that there was no audio.

Manufacturer Narrative

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

Manufacturer Narrative

An evaluation of the kangaroo epump was performed for the reported condition of, ¿service found that there was no audio.¿ the unit was triaged and the reported condition was confirmed.When the pump was powered on startup tones were not audible.Internal inspection revealed a damaged component u14 in the buzzer circuit.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: 7685457
• MDR Text Key: 114334123
• Report Number: 1282497-2018-00578
• Device Sequence Number: 1
• Product Code: LZH
• UDI-Device Identifier: 10884521006614
• UDI-Public: 10884521006614
• 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: 10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2018
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2018
• 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: Unknown
• Patient Sequence Number: 1