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

Model Number 482400J

Device Problems Decreased Pump Speed (1500); Insufficient Flow or Under Infusion (2182)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

An evaluation of the kangaroo pump was performed and the customer states, ¿unit was set for night feeds and it's supposed to finish at 5am however the feed is finishing between 6-6:30am".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.

Event Description

The customer reported: the patient is set for night feeds and it's supposed to finish at 5am however the feed is finishing between 6 -6:30am.

• Brand Name: KANGAROO
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; 15 hampshire st; mansfield MA 02048
• Manufacturer (Section G): COVIDIEN; 15 hampshire st; mansfield MA 02048
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 7316315
• MDR Text Key: 101730184
• Report Number: 1282497-2018-00158
• Device Sequence Number: 1
• Product Code: LZH
• UDI-Device Identifier: 10884521174818
• UDI-Public: 10884521174818
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2018
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2017
• Date Manufacturer Received: 11/27/2017
• 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