MAUDE Adverse Event Report: BAXTER CORPORATION EXACTA-MIX (TM) INLET

Model Number H938175

Device Problem Misassembly by Users (3133)

Patient Problem No Code Available (3191)

Event Date 08/04/2014

Event Type  No Answer Provided  

Event Description

On october 13, 2014, baxter (b)(4) received medwatch mw5037484 from the fda, through (b)(4).The post-mark date was identified as 10/08/2014; therefore, per our procedure, the post-mark date will serve as our received date.The medwatch identifies an issue with a baxa exactamix i.V.Fluid transfer neonatal tpn mixer, but does not list a specific part number.The reporting facility was not provided, therefore, we are unable to contact the reporting facility for further clarification.The event date was also omitted; however, the event was reported to the fda on (b)(6) 2014.The event description from the unidentified facility states, "we had an incident where our neonatal tpn mixer was set-up incorrectly by a nicu technician but not caught during the pharmacist's double check.The na acetate was connected to the k acetate port and vice versa.As a result, 2 babies received 4-5 hours of the tpn with the wrong formula before the error was noted by the event shift iv room pharmacist.Nursing and the neonatologist on call were notified and the babies' electrolytes were followed closely.Fortunately, there were no significant changes in their electrolytes and they incurred no significant harm.Upon investigation, we found that the error occurred because when the tech was setting up, they realized they forgot the vial of na acetate and had to break their routine to go retrieve it.The pharmacist usually worked the evening shift which does not normally check the set-up and as a result forgot to follow the tubing from the port to the vial as part of her check.The staff was counseled and all pharmacy staff is being re-educated on the proper check procedure.The check procedure is also being revised to be made uniform across all shifts.In addition, a 3rd check our institution uses is baxa exactamix to prepare our neonatal tpns.We use a barcoding system during set-up to minimize errors of selecting the wrong vials; however, despite that, the potential for error still exists when connecting the tubing to the 24-port valve assembly.The ports are numbered in clear raised print, one row behind the other.It is difficult to see the numbers on the back row without sticking your head inside of the hood.There is no color coding or barcoding while connecting the ports.".

Manufacturer Narrative

No testing methods performed.No results available since no evaluation was performed.Conclusions: user error caused event.According to the em2400 operator's manual, there is a warning statement that says, "scan only the bar codes attached to the inlet and the corresponding source container.Do not scan unattached bar codes or old (used) containers.Doing so may result in incorrect ingredient delivery, resulting in patient harm." the manual goes on to say that a cosigner may need to log in and verify the setup, if that is the facility's protocol.The manual has a warning message about the cosigner, "it is important to have a cosigner independently verify the setup, to help ensure that the first user attached each ingredient's inlet to the correct port.Incorrect setup could result in patient harm." also, during prime and verify, the manual notes that an ingredient detail window will appear that the pharmacist is required to review.Then the manual states, "on the valve set, locate the port of this ingredient.With your hand, hold the inlet that is attached to the port, and follow the inlet up to the source container." while holding the inlet near the source container, baxter outlines a few more checks, such as, ensure the number on the inlet label matches the port number and ensure the product attached to the inlet matches the information on the screen.The medwatch report states, the pharmacist usually worked the evening shift, which does not normally check the set-up.Additionally, the pharmacist admitted that she forgot to follow the tubing from the port to the vial as part of her check.Therefore, the complaint has been confirmed and the root cause is attributed to a user error.After this event, the entire pharmacy staff was re-educated on the proper check procedure.The customer's check procedure was also being revised to ensure it was uniform across all shifts.They use a barcoding system during set-up to minimize errors of selecting the wrong vials.The customer noted that the potential for error still exists when connecting the tubing to the 24-port valve.The ports are numbered in clear, raised print, one row behind the other.It is difficult to see the numbers on the back row without sticking your head inside the hood.There is no color coding or barcoding while connecting the ports.The customer's enhancement request has been forwarded to the design team reasonable for the em2400 compounder.Product will not return.

• Brand Name: EXACTA-MIX (TM) INLET
• Type of Device: EXACTA-MIX (TM) INLET
• Manufacturer (Section D): BAXTER CORPORATION; 14445 grasslands dr; englewood CO 80112 706
• Manufacturer (Section G): BAXTER CORPORATION; 14445 grasslands dr; englewood CO 80112 706
• Manufacturer Contact: 9540 south maroon circle; suite 400; englewood, CO 80112 ; 3036904204
• MDR Report Key: 4215416
• MDR Text Key: 5038515
• Report Number: 1419106-2014-00012
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): N
• PMA/PMN Number: K002705
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Type of Report: Initial
• Report Date: 10/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: H938175
• Device Catalogue Number: H938175
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/13/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1