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

Model Number 673662

Device Problems Infusion or Flow Problem (2964); No Flow (2991)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Submit date: 09/21/2016.An investigation is currently under way; 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: no nutrition or water will pass through the device, there was no patient harm.

Manufacturer Narrative

A device history record of the sample lot# was performed and confirmed that the product was produced accomplishing all quality requirements and was released according to all established procedures.One sample was received for evaluation.The received sample was evaluated visually and functionally.The sample was cleaned and the test performed with water passed through the device confirming that the set was good and no obstruction was observed during the functionally test.This complaint will be used for tracking and trending purposes.

Event Description

Customer reports: no nutrition or water will pass through the device, there was no patient harm.

• Brand Name: EPUMP INTL 1000ML FD AND FLUSH
• 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: 5967061
• MDR Text Key: 55670180
• Report Number: 1282497-2016-00714
• Device Sequence Number: 1
• Product Code: LZH
• Combination Product (y/n): N
• Reporter Country Code: CO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 673662
• Device Catalogue Number: 673662
• Device Lot Number: 160430220
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1