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

Model Number 482400J

Device Problem No Display/Image (1183)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Submit date: 4/16/2018.If information is provided in the future, a supplemental report will be issued.

Event Description

The customer states the unit has no display.

Manufacturer Narrative

No sample available.Without the unit, a detailed investigation could not be performed and the reported condition could not be confirmed.This complaint file shall be closed as unconfirmed at this time.If the unit is returned, the complaint shall be re-opened.A review of the device history record shows that this unit was manufactured and was released meeting all manufacturing specifications.Complaint trending information is being reviewed on a routine basis and if a trend is observed, actions will be taken as necessary.This information will be utilized for tracking and trending purposes.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

An evaluation of the kangaroo pump was performed and the customer states ¿the unit has no display.¿ the unit was triaged and the reported issue could not be confirmed at this time.A review of the device history record shows that this unit was manufactured in 2016 and was released meeting all manufacturing specifications.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.

Event Description

The customer states the unit has no display.

• 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: 7432886
• MDR Text Key: 105660489
• Report Number: 1282497-2018-00275
• Device Sequence Number: 1
• Product Code: LZH
• UDI-Device Identifier: 10884521174818
• UDI-Public: 10884521174818
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/16/2018

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: 482400J
• Device Catalogue Number: 482400J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/22/2018
• Initial Date FDA Received: 04/16/2018
• Supplement Dates Manufacturer Received: 03/22/2018; 10/15/2018
• Supplement Dates FDA Received: 09/07/2018; 10/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/18/2016
• 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