MAUDE Adverse Event Report: COVIDIEN EPUMP 1000ML PUMP SET; PUMP, INFUSION, ENTERAL

Model Number 773656

Device Problem Infusion or Flow Problem (2964)

Patient Problems Vomiting (2144); No Code Available (3191)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.

Event Description

The customer reported air in the feeding line and stated that the patient had to go to the hospital because they started throwing up and retching during the feedings.The hospital team could not find anything wrong with the patient and the patient tolerated feedings fine during admission so they attributed it to the air in the line from the feeding bags.The patient is now back home and doing fine.Additional information received from the initial reporter on (b)(6) 2020 stated that the patient went to the er and then was admitted to the hospital for 7 days.The only symptoms reported were vomiting and retching during feedings overnight when no one was monitoring the feedings as they feel this is when air was pushed into the patient through the tubing.During the daytime feedings, they were able to see the air bubbles and stop the feeds right away and the patient did not have symptoms during the day.The rn reported that the hospital found nothing wrong with the patient.No further details are known at this time.

Manufacturer Narrative

Section g4 date received by manufacturer was updated from 24-sep-2020 to 8-oct-2020 since cardinal health was made aware of the adverse event (hospitalization) on 8-oct-2020.

Manufacturer Narrative

Type of reportable event was updated from serious injury to malfunction.

• Brand Name: EPUMP 1000ML PUMP SET
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 10781717
• MDR Text Key: 214791685
• Report Number: 1282497-2020-09597
• Device Sequence Number: 1
• Product Code: LZH
• UDI-Device Identifier: 10884521022096
• UDI-Public: 10884521022096
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 01/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 773656
• Device Catalogue Number: 773656
• Device Lot Number: 200760125
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/08/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization