MAUDE Adverse Event Report: COVIDIEN EPUMP FEED AND 1000ML FLUSH SET; ENTERAL FEEDING PUMP SET

Model Number 773662

Device Problems Device Displays Incorrect Message (2591); Infusion or Flow Problem (2964)

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

Event Date 07/11/2016

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 (b)(6) 2016 that a customer had an issue with an enteral feeding pump set.The customer reports the set would not flow and the pump kept an error code because the set would not allow food through it.The issue was noticed post priming.The patient was using jevity 1.5 formula.

Manufacturer Narrative

Submit date: 10/11/2016.A device history record of the sample lot number was performed and confirmed that the product was produced accomplishing all quality requirements and was released according to all established procedures.Functional and visual evaluations were performed on the sample, the sample was observed with dried formula clogging the pvc lines and valve, once this food was removed, the bag functioned for 2 hrs.Without any priming or flow issues.No fault was reproduced or found with the sample returned.Root cause was not verified, no fault was found; possible root cause could be that the formula dried up and clogged the pvc line while the bag was not in use for a long period or a possible misalignment of the stem in the valve due to overuse (more than 24 hrs).No corrective actions will apply since failure mode was not confirmed.This complaint will be used for tracking and trending purposes.

• Brand Name: EPUMP FEED AND 1000ML FLUSH SET
• Type of Device: ENTERAL FEEDING PUMP SET
• Manufacturer (Section D): COVIDIEN; 37 blvd. insurgentes libriamento; a la p, la mesa; tijuana ; MX
• Manufacturer (Section G): COVIDIEN; 37 blvd. insurgentes libriamento; a la p, la mesa; tijuana ; MX
• Manufacturer Contact: edward almeida ; 15 hampshire st; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 5816074
• MDR Text Key: 51038311
• Report Number: 1282497-2016-00529
• Device Sequence Number: 1
• Product Code: LZH
• 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,Followup
• Report Date: 07/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 773662
• Device Catalogue Number: 773662
• Device Lot Number: 160990203
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/12/2016
• Initial Date FDA Received: 07/22/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/06/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1