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

Model Number UNKNOWN ENTERAL FEEDING

Device Problem Improper Flow or Infusion (2954)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/02/2020

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.

Event Description

The customer reported that there was an air space in the tubing between the pump and the patient.There were no error codes.The patient is being fed 5 times a day and 2 hours per feeding using a g-tube delivery at a rate of 150ml/hour and volume of 300ml (260ml of peptamin junior milk and 40ml of water).Feedings are from 5am-7am, 9am-11am, 1pm-3pm, 5pm-7pm, 9pm-11pm.They noticed that the feeding would end 15 minutes later for the last couple of days (normally feeding lasts 2 hours).The issue happened on the third day of using the feeding set.Normally they change the set every 4-5 days.The patient was not over/under fed and there was no harm to the patient.

• Brand Name: UNKNOWN ENTERAL FEEDING
• 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: jill saraiva ; 15 hampshire street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 10975529
• MDR Text Key: 220435009
• Report Number: 1282497-2020-09770
• 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,consum
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: UNKNOWN ENTERAL FEEDING
• Device Catalogue Number: UNKNOWN ENTERAL FEEDING
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/02/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1