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

Model Number 383400

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

The customer reported a service issue with an enteral feeding pump.During triage on (b)(6) 2018 the service tech found that the enteral feeding pump was under delivering during testing.

Manufacturer Narrative

The customer reported a service issue with an enteral feeding pump.During triage on 17-sep-2018 the service tech found that the enteral feeding pump was under delivering during testing." to "the customer reported the enteral feeding pump was running too fast and not at normal speed." date received by manufacture was updated from "17-sep-2018" to "13-aug-2018".An evaluation of the kangaroo joey pump was performed and the customer states ¿running to fast, not normal speed.¿ the unit was triaged and the reported issue could not be confirmed at this time; during testing the unit did not run too fast.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.

Event Description

The customer reported the enteral feeding pump was running too fast and not at normal speed.

• 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 street; mansfield MA 02048
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 7947567
• MDR Text Key: 123097774
• Report Number: 1282497-2018-08103
• 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,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 383400
• Device Catalogue Number: 383400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1