MAUDE Adverse Event Report: COVIDIEN KANGAROO JOEYPUMP W/POLE CLMP; PUMP, INFUSION, ENTERAL

Model Number 383400

Device Problem Excess Flow or Over-Infusion (1311)

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

Event Type  malfunction  

Manufacturer Narrative

The pump, s/n: (b)(4), was received and evaluated.During evaluation it was noticed that the ultrasonic, gearbox, encoder and rotor assembly were damaged.The parts were replaced and pump is functioning as intended.The service history record was reviewed, this device was manufactured in 2013 and this is the first time this device has been returned for service.The reported event was determined to be caused by customer mishandling of the device.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 over dosing by 30 ml.

• Brand Name: KANGAROO JOEYPUMP W/POLE CLMP
• 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: 12072917
• MDR Text Key: 258726479
• Report Number: 1282497-2021-10442
• Device Sequence Number: 1
• Product Code: LZH
• UDI-Device Identifier: 10884521006645
• UDI-Public: 10884521006645
• 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: 06/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2021
• 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?: Yes
• Date Manufacturer Received: 01/13/2020
• 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