MAUDE Adverse Event Report: APPLIED MEDICAL TECHNOLOGY INC. AMT MINI ONE; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number M1

Device Problems Product Quality Problem (1506); Output Problem (3005)

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

Event Date 02/04/2017

Event Type  Injury  

Event Description

Despite the intention of the product design, the complexity of issues related to the device design make it nearly impossible to ensure proper use or to avoid misconnections and damage to the device.Amt buttons have two different port connections (gastric port vs.Jujenal port) and two different extension sets (feedings vs.Medications/venting) that are meant to avoid use of the wrong port for feeding.Most patients with a gj tube have one placed due to motility issues in their stomach so it is placed to feed into their jejunum with a goal to prevent accidental feeding in the stomach.However, the connections are not mutually exclusive.The wrong extension can easily and snugly fit into the incorrect port failing to prevent misconnection and use of the wrong port and leading to damage upon removal/disconnection.The ports are intended to be different colors to assist in differentiating between the gastric port (white) and jejunal port (glow green) on the gjet however, the two ports are not significantly different in color in daylight.Adding to confusion, the "j" port of gjet (gj tube) is the same as the "g" port of the mini one button (gt).Both are supposed to use the same "glow" extension set to feed.Staff must know to use the "glow" extension for the g port but also know to use the "glow" set for the g port of the gt mini one button (gt mini one= extension only--> g port; gjet (gj)=glow extension--> j port + white/medication extension--> g port) labels of "g" and "j" on caps of button but unable to see when open.Sticker on extension can be removed and not at point of use.Harm: use of the wrong extension type in the wrong extension type in the wrong port leads to either valve/port damage or balloon failure and requires replacement as the tube either leaks or will no longer stay in the tract (dislodgment).In most cases, the gt can be replaced at the bedside however, replacement of the gj tube (gjet) requires and additional procedure with sedation.Packaging concerns: amt mini one button and amt gjet packaging states they are mic-key extension compatible.As shown by one instance where a mic-key extension was connected to an amt g-tube that was leaking and required replacement.Several instances of button failures requiring replacement on a single med-surg unit where it was determined the mic-key extensions were the extension stocked and primarily being used (gjet- 2 balloon failures and 2 valve failures; mini on gt-7 balloon failures and 4 valve failures).Misleading: packaging stated that the white g extension was "feeding set" on non-feeding extension.However, the white g extension should only be used for medication admin via the "g" port of the gjet button.Yet there are rare circumstances where a patient may have a gj tube but actually requires feeding through the g port.The manufacturer has agreed to correct the product box which beside staff do not see as well as the product packaging which they often do not read, this does not solve the problems related to the white g extension.No intent indicated by the manufacturer to make any actual device modifications.Steps taken at our hospital to address: met with manufacturer including amt product engineers to discuss concerns related to coloring and ability to misconnect.Discussed opportunities in device design including mutually exclusive ports to prevent ability to misconnect as well as more obvious color differences.Packaging/labeling and design concern as stated above.Provided vendor failed tubes for investigation with plan to investigation with plan to investigate potential changes in mic-key extension.Education to not use mic-key with amt.Fda safety report id # (b)(4).

• Brand Name: AMT MINI ONE
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): APPLIED MEDICAL TECHNOLOGY INC.; brecksville OH 44141
• MDR Report Key: 9116423
• MDR Text Key: 160152034
• Report Number: MW5089994
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/20/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M1
• Device Catalogue Number: M1-5-1210
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 5 YR
• Patient Weight: 15