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

Model Number 773656

Device Problem Device Inoperable (1663)

Patient Problem No Information (3190)

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 two enteral feeding pump sets.The customer reports that for a patients bolus feeding, two different kangaroo bags would not work.They primed well but would ring occlusion after about 2-3ml.Rn also attempted three different pumps with the same results.The third bag worked.

Manufacturer Narrative

An investigation is currently under way; upon completion, the results will be forwarded.

• Brand Name: EPUMP 1000ML PUMP 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 Key: 5896998
• MDR Text Key: 53796537
• Report Number: 1282497-2016-00642
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 773656
• Device Catalogue Number: 773656
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1