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

Model Number 382401

Device Problem Inaccurate Flow Rate (1249)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/27/2020

Event Type  malfunction  

Manufacturer Narrative

The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.

Event Description

The customer reported that the unit was set at 5cc/hour with a volume to be infused of 10cc.Pump was running at 60cc/hr and a volume to be infused of 800cc.

Manufacturer Narrative

Evaluation summary all device history records (dhr) are reviewed for quality inspections and parameter compliance prior to releasing the product for shipment.The device was received at the service center for evaluation.Corrosion was observed on the printed circuit board (pcb).The rotor was not spinning freely and there was damage to the overlay of the buttons.Housing damage was also noticed.The issue reported by the customer was confirmed.The root cause of the issue was corrosion on the printed circuit board (pcb).The corrective action was to replace the pcb and service the unit replacing the damaged parts.The reported problem was resolved.Complaint trend analysis (cta) will be performed and reviewed by the corrective and preventative action (capa) trending review board to further evaluate requirements for capa escalation as an improvement activity and inputs to management review.This complaint will be used for tracking and trending purposes.

Manufacturer Narrative

the serial number reported initially was incorrect.The following section have been updated:

section d4: serial number - (b)(6).

• Brand Name: KANGAROO EPUMP - RFB
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 10765919
• MDR Text Key: 214156578
• Report Number: 1282497-2020-09586
• Device Sequence Number: 1
• Product Code: LZH
• UDI-Device Identifier: 00884521006621
• UDI-Public: 0884521006621
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 02/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2020
• 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: 10/28/2020
• Patient Sequence Number: 1