MAUDE Adverse Event Report: COVIDIEN ENTERAL FEEDING PUMP

Model Number UNKNOWN ENTERAL FEEDING PUMP

Device Problems Device Alarm System (1012); Complete Blockage (1094); Precipitate in Device or Device Ingredient (1478); No Flow (2991)

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

Event Date 07/05/2016

Event Type  malfunction  

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.

Event Description

It was reported to covidien on 07/06/2016 that a customer had an issue with an enteral feeding pump.The customer states that the set had a pack of aminoleban with 200ml of hot water par 33ml/h.The set seemed to clogged and the pump was working (turning) but the formula did not flow forward.The tubing became cloudy and the formula seemed to be precipitated inside it.The pump did not alarm.At the 2nd feeding, empty alarm occurred but 180ml of water was left inside the bag.No patient harm.

Manufacturer Narrative

Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the fda 3500a form and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.Medtronic objects to the use of these words and others like it because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

A device history record review could not be performed because a lot number was not received with the complaint.Sample was received.The pump set could not fit with pump tester.A scar was issued to our supplier to address the root cause and action for solving this.A corrective action has been taken to address this issue.This complaint will be used for tracking and trending purposes.Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the fda 3500a form and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.Medtronic objects to the use of these words and others like it because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENTERAL FEEDING PUMP
• Type of Device: ENTERAL FEEDING PUMP
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 5784843
• MDR Text Key: 50098780
• Report Number: 8040459-2016-00007
• 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: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN ENTERAL FEEDING PUMP
• Device Catalogue Number: UNK EF
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1