MAUDE Adverse Event Report: COVIDIEN CONNECT FEEDING PUMP; PUMP, INFUSION, ENTERAL

Model Number 384400

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/26/2018

Event Type  malfunction  

Event Description

The customer reports the nurse placed 110ml in the feeding bag of the connect feeding pump.The pump was programmed to deliver 96 ml to the patient over one hour.At the end of the hour, the pump indicated 96 ml was delivered, yet it visually appeared as though half or more of the feed was remaining in the bag.The nurse noted a kink in the tubing at the top of the cassette.It was confirmed that the tubing was kinked and the pump does not alert for occlusion.The pump was observed while running the test feed for a few minutes and the pump indicated that 10 ml was delivered but it was measured that only 2 ml was delivered.

• Brand Name: CONNECT FEEDING PUMP
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• Manufacturer (Section G): COVIDIEN; 15 hampshire street; mansfield MA 02048
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 7934062
• MDR Text Key: 122662092
• Report Number: 1282497-2018-08094
• 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
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 384400
• Device Catalogue Number: 384400
• Date Manufacturer Received: 09/21/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1