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

Model Number 382401

Device Problem Sparking (2595)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

The reported pump s/n:(b)(4) was returned and evaluated.The pump was received in a used condition.The pump was functionally tested and the customer reported failure was not confirmed.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 that the device was sparking.

• Brand Name: KANGAROO EPUMP - RFB
• 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: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 12071160
• MDR Text Key: 258748589
• Report Number: 1282497-2021-10321
• Device Sequence Number: 1
• Product Code: LZH
• UDI-Device Identifier: 10884521006621
• UDI-Public: 10884521006621
• 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
• Report Date: 06/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 382401
• Device Catalogue Number: 382401
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/29/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1