MAUDE Adverse Event Report: COVIDIEN CONNECT FEED SET 500ML NS; ENTERAL FEEDING PUMP

Model Number 77500FD

Device Problems Air Leak (1008); Device Displays Incorrect Message (2591)

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

Event Type  malfunction  

Manufacturer Narrative

Submit date:1/28/2017.An investigation is currently under way.Upon completion the results will be forwarded.

Event Description

It was reported to covidien on (b)(6) 2017 that a customer had an issue with an enteral feeding pump.The customer reports that the tubes are crushed and create an alarm upon power up of the pump.Also, there are bubbles in the feed bag.No patient injury or ill effects.

Manufacturer Narrative

Death was checked off in error on the initial report.This should have been submitted as a malfunction as there was no patient injury or ill effects.

• Brand Name: CONNECT FEED SET 500ML NS
• Type of Device: ENTERAL FEEDING PUMP
• 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: 6285288
• MDR Text Key: 66321058
• Report Number: 1282497-2017-00158
• Device Sequence Number: 1
• Product Code: LZH
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 01/10/2017

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: 77500FD
• Device Catalogue Number: 77500FD
• Device Lot Number: 152960128
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/10/2017
• Initial Date FDA Received: 01/28/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/01/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1