MAUDE Adverse Event Report: COVIDIEN EPUMP SAFETY SCREW SPIKE SET; PUMP, INFUSION, ENTERAL

Model Number 775659

Device Problem Air/Gas in Device (4062)

Patient Problem Feeding Problem (1850)

Event Date 12/07/2020

Event Type  malfunction  

Manufacturer Narrative

The incident sample has been requested but to date has not been received for evaluation.  if the sample 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 Description

The patient reported that air space was building up in the tubing between the bottle and the pump while they were being fed at a rate of 62 ml/hr.The pump was giving empty bag, obstruction, and feeding errors.The patient was underfed because of the issue happening at night and wasn't fed the rest of the bottle until the morning.The patient has two feedings a day.The first feeding is from 9pm to 10am (13 hours) for a volume of 806ml.The second feeding is from 1pm to 6pm (5 hours) for a volume of 310ml via j-tube delivery.The patient is fed osmolite 1.2 cal (1.5l).The tubings are changed every 24 hours.It is unknown how long the tubing was in use before the issues occurred.There was no patient injury.

Manufacturer Narrative

Section e1 has been updated to include the initial reporter's home address which they provided today ((b)(6) 2020).

Manufacturer Narrative

Investigation summary: the customer reported air space was building up in the tubing between the bottle and the pump during use.No patient injury/harm reported.The device history record review of the reported lot number shows evidence that the product was released according to all established procedures and qa documentation.One used sample was received for evaluation.Visual inspection concluded the tubing line was clogged with food.Functional testing was unable to be completed due to the old food clogged in the tubing line.The report of "air in line" is unable to be confirmed and additional action is not required at this time.This complaint will be used for tracking and trending purposes.

• Brand Name: EPUMP SAFETY SCREW SPIKE SET
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 11002372
• MDR Text Key: 221274047
• Report Number: 1282497-2020-09779
• Device Sequence Number: 1
• Product Code: LZH
• UDI-Device Identifier: 10884521155831
• UDI-Public: 10884521155831
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial,Followup,Followup
• Report Date: 05/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 775659
• Device Catalogue Number: 775659
• Device Lot Number: 202650071
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/07/2020
• Patient Sequence Number: 1