MAUDE Adverse Event Report: COVIDIEN UNKNOWN ENTERAL FEEDING DURABLES; PUMP, INFUSION, ENTERAL

Device Problems Fail-Safe Problem (2936); Infusion or Flow Problem (2964)

Patient Problem Discomfort (2330)

Event Date 03/06/2021

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 while using an unknown pump with an unknown serial number the pump was started per usual usage for a feeding, and the distal line was occluded.The distal occlusion alarm failed resulting in a spillage of formula, this is not a first-time occurrence.The occurrence rate for this is all the time if the distal end is occluded by clamping and when tested in a test environment it occurs at least 75% of the time.This has been seen with multiple pumps from this model / make.No labs or tests can be collected aside from measuring flow from the pump to a graduated cylinder and examining the wild inaccuracy in the pump's delivery 25% greater or lesser deviation from set infusion.Additional information received stated that the devices cased minor discomfort but no injury resulted.

• Brand Name: UNKNOWN ENTERAL FEEDING DURABLES
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 11710059
• MDR Text Key: 246984466
• Report Number: 1282497-2021-10095
• Device Sequence Number: 1
• Product Code: LZH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 04/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/14/2021
• Patient Sequence Number: 1