MAUDE Adverse Event Report: COVIDIEN JOEY 500ML PUMP SET; PUMP, INFUSION, ENTERAL

Model Number 762055

Device Problem Air/Gas in Device (4062)

Patient Problems Vomiting (2144); Convulsion/Seizure (4406)

Event Date 11/26/2020

Event Type  Injury  

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.

Event Description

The customer reported air spacing (6-8 inches in length) appearing in the enteral feeding set tubing between the pump and the (b)(6) year old male patient who suffers from leukodystrophy.The accumulation of air in the stomach caused the patient to vomit which in turn triggered an epileptic seizure.The issue started when they opened a new case of item 762055, lot# 201600024 on (b)(6) 2020 and used five sets since then.The pump did not alarm because the air was in the tubing between the pump and the patient.The patient is fed at 45ml/hr with a volume of 750ml.Feeding starts at 8am and ends at 2am the following morning.Feedings have to be done 250ml at a time because the food has to be administered while still cold because of the patient's condition.Length of feeding is approximately 18hrs.The patient was not over fed or under fed but the feedings were delayed when they had to change the sets every time.They normally change the sets every three days.The patient has a g-tube for delivery.Additional information provided on 10-dec-2020 stated that the patient has a history of seizures due to his rare disease.Vomiting does happen every now and then with the patient's condition, sometimes once during one week, sometimes once within 2 week.It varies all the time) but the vomiting was a lot worse (more volume) when having the issue of air going into his stomach.When the patient vomits, the parent has to aspirate (they have an aspirator at home) the vomit to make sure it doesn't get into his lungs (patient is always positioned on his back) and has to stay right next to their child the next 24-hrs to monitor him.The patient is not conscious when having seizures.The patient is on numerous medications that are given to him on a daily basis to treat his disease and control his epileptic seizures (prevacid, lamictal, mogadon, domperidone, vimpat, melatonin, selenium, cannabis oil, ativan).When the seizures happens, the customer has to communicate with the doctor who will then instruct which medication to give his son and how much.The patient was being fed ketocal 4 2.1 (by nutricia).The patient's current status is stable.

Manufacturer Narrative

Investigation summary: the customer reported air bubbles in the enteral feeding line located after the black rotor on the epump.No patient injury was reported.A device history record review of the reported lot number shows evidence that the product was released according to all established procedures and qa documentation.Product lot and failure mode trending was reviewed and a trend was not identified for the reported lot number or device failure.The reported device was not returned for evaluation; however, photographs and videos were provided by the customer.An evaluation of the provided photographs and videos confirmed the reported issue of air in line/tubing.An investigation has been initiated to determine the root cause of this device failure.The root cause and conclusion of the confirmed device failure will be documented within the investigation.This product issue will continue to be monitored and trended.

Manufacturer Narrative

Investigation summary: a total of four (4) samples were returned for evaluation.Visual inspection and functional testing confirmed the report of air in line.An investigation has been initiated to determine the root cause of this device failure.The root cause and conclusion of the confirmed device failure will be documented within the investigation.This product issue will continue to be monitored and trended.

• Brand Name: JOEY 500ML PUMP SET
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 11033331
• MDR Text Key: 222311280
• Report Number: 1282497-2020-09800
• Device Sequence Number: 1
• Product Code: LZH
• UDI-Device Identifier: 10884521072299
• UDI-Public: 10884521072299
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup
• Report Date: 04/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 762055
• Device Catalogue Number: 762055
• Device Lot Number: 201600024
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/30/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 4 YR