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

Model Number 763656

Device Problems Failure to Prime (1492); Product Quality Problem (1506); Device Displays Incorrect Message (2591); Improper Flow or Infusion (2954); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/17/2017

Event Type  malfunction  

Event Description

Covidien makes "joey" enteral feeding systems - pumps and bags.For the last month, we have received bags that don't prime, or bags that fault during various staged of feeding (either in the middle or when adding more formula).Some probable root causes are - the distance b/w valves gets slightly stretched (the smallest stretch can result in a bad bag (about 25% of the failures are this type), which points to shoddy design/lack of human factors considerations), the valve the controls the flow does not open/close (most common when the bags don't prime - about 75% of failures i noted are this type - which points to quality controls), or the liquid becomes slightly viscous (the pump seems delicate).While this is not "life threatening", i'm utilizing roughly twice the number of bags as i should be; i.E., i'm consuming, on average 2 bags/day.The error displayed on the pump lists three possible issues, which are the only three issues that the pump can have, so the error message is not helpful.We are not covidien's qc.I called covidien and they didn't service bags, just the pumps.It was also not clear how it was sourced (i was routed to three different customer service lines.) so, it seems there is no complaint management system for the bags.I also emailed the sales rep who never emailed me back.We asked our medical supplies company if the issue is us (the user) and they said it was a "known issue" and could only replace bags, and if the issue continues, they could replace the pumps, and barring that, they could offer us another company's enteral feeding solution.Additionally our nurses (who stay home with my son) have had the same issues, so it's not isolated to the parents.We asked if the issue was with us, (the user) so we could be retained, and the supplies company ((b)(4)) said they sporadically have bag issues so it was unlikely to be the user.The company seems not to have thought through simple human factors when designing the pump.Example: the tubing can easily fault if stretched.This means the user needs to handle the bag very carefully when refilling the bags without risking failure.A simple spring (coil) in the tubing to allow "slack" could lower the occurrence in this failure mode.The feedings are for my preschooler ((b)(6)) and he tends to be very active, he will often run without watching out for the cord; this means he can stretch the cord from the user side and fault the system and cause us to replace the bags, so again a "slack" in the system to handle sudden jerks would be one solution.It's clear covidien did not consider human factors or pediatric human factors in their pump/bag design.Another example.The ifu states the bag must be hung 6" (inches) higher than the pump, but the backpack provided does not achieve this requirement.Additionally, this makes refilling the bag non ergonomic (either the user need to bend over to use the pump, or be very awkward when filling the bag).The error messages on the pump are not informative, but a laundry list of all the issues that could be wrong with the system.The pumps are easy to use, and replacing the bags is an inconvenience, however, the user should not have to deal with 50% failure rate; this is no longer an acceptable rate of "inconvenience.".

• Brand Name: JOEY PUMP SET
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 6894078
• MDR Text Key: 87517142
• Report Number: MW5072433
• Device Sequence Number: 1
• Product Code: LZH
• UDI-Device Identifier: 10884521072305
• UDI-Public: 10884521072305
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 09/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Model Number: 763656
• Device Lot Number: 172090212
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 3 YR
• Patient Weight: 14