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

Model Number	384400
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device involved in this incident has been requested but to date has not been received for evaluation. if the device is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted. as part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
Event or Problem Description
The customer reported that with a rate of 175 ml/hr the connect feeding pump fed a 220 ml dose in under a half an hour.
Additional Manufacturer Narrative
An evaluation of the pump was performed.All device history (dhr) record are reviewed for quality inspections and compliance prior to releasing the product for shipment.A functional test and visual inspection were completed.The connect pump was de-certified, upgraded to 2.03 and performed a re-certification test.Part of the certification process is to test the functionality of the pump with a feeding set and water.A new feeding set was used to perform this certification.The possible root cause could be because of a faulty ultrasonic sensor assembly.The ultrasonic sensor assembly will be replaced, and a factory certification will be completed on the pump.Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.This complaint will be used for qa tracking and trending purposes.

• Brand Name: CONNECT FEEDING PUMP
• Common Device Name: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 9689268
• Report Number: 1282497-2020-08914
• Device Sequence Number: 11600679
• Product Code: LZH
• UDI-Device Identifier: 10884521190894
• UDI-Public: 10884521190894
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2020

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
• Operator of Device: No Information
• Device Model Number: 384400
• Device Catalogue Number: 384400
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/13/2020
• Supplement Date Received by Manufacturer: 01/13/2020
• Initial Report FDA Received Date: 02/10/2020
• Supplement Report FDA Received Date: 03/23/2020
• Patient Sequence Number: 1