MAUDE Adverse Event Report: CARDINAL HEALTH 666064 JOEY 500ML SET X30; PUMP, INFUSION, ENTERAL

Model Number 666064

Device Problem Air/Gas in Device (4062)

Patient Problem Pain (1994)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported that there was a defective 500ml reservoir set.Air was being sucked into the line where the leaver goes into the top of the pump and then downstream air gaps appeared.During feeding, there was no alarm sound and this was just noticed by the patients father.He noticed the patient woke up at 4:00am in pain and there was air in the line; at that point, he was taken off the feed.He got rid of the wind and vomits and was comfortable afterwards.They tested the dirty set and 2 pumps.They watched the feeds at the point where the lever slides into the top of the set around the road where it is being sucked down the line.The rate is 50 mls an hour night and day time feed is rate 170mls per hour with this batch and they experience the same issue ¿ noise of pump wind back noise, "wurring" noise circular where the first part of set slides into metal upright holder.It is evident on 50mls an hour and harder to see with lower rate until the patient is in pain.A higher rate also happens and is more evident sooner.The patient missed 40ml of night time feed due to not being able to continue feeding.The feed he had vomited was 230mls out of his 410ml feed.He vomited multiple times during the day yesterday.The patient required constant hydration at 8 intervals throughout the day.Any missed volume can not be re-fed due to their feeding schedule.

Manufacturer Narrative

Physicals samples were not received for the investigation; however, videos of the reported issue were received.The device history record was reviewed and indicated that the product was released accomplishing all quality standards.Because a physical sample was not returned, we were unable to perform a follow up investigation to include functional evaluation.Upon a visual evaluation of the video, the defect was confirmed; there was air in the line.A corrective and preventive action has been initiated to address the reported issue.If a sample is received at a later date, this complaint will be reopened for further investigation.

• Brand Name: 666064 JOEY 500ML SET X30
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; sragh industrial estate, co, t; offaly ; EI
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 17481585
• MDR Text Key: 320614504
• Report Number: 9611018-2023-00608
• Device Sequence Number: 1
• Product Code: LZH
• Combination Product (y/n): N
• Reporter Country Code: EI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 666064
• Device Catalogue Number: 666064
• Device Lot Number: 22G051FHX
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1