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U.S. Department of Health and Human Services

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

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COVIDIEN EPUMP FEED AND 1000ML FLUSH SET; ENTERAL FEEDING PUMP SET Back to Search Results
Model Number 773662
Device Problems Device Displays Incorrect Message (2591); No Flow (2991)
Patient Problem No Known Impact Or Consequence To Patient (2692)
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: 11/09/2016.The device history record was reviewed and indicated that the product was released accomplishing all quality standards.There were no samples received for evaluation.Because a sample was not available for evaluation, a root cause analysis could not be conducted to determine the root cause of this reported issue.If samples are received at a later date, this complaint will be re-opened and the investigation continued.A corrective action is not applicable at this time.This complaint will be used for tracking and trending purposes.
 
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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 street
mansfield, MA 02048
5084524151
MDR Report Key5816583
MDR Text Key51030825
Report Number1282497-2016-00537
Device Sequence Number1
Product Code LZH
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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
Date FDA Received07/22/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number773662
Device Catalogue Number773662
Device Lot Number160990203
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received11/09/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
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