MAUDE Adverse Event Report: BAXA BAXA EXACTAMIX; NEONATAL TPN MIXER

Device Problem Misconnection (1399)

Patient Problem No Code Available (3191)

Event Type  Other  

Event Description

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 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.Patient counseling provided: unk.Relevant materials provided: none.(b)(4).

• Brand Name: BAXA EXACTAMIX
• Type of Device: NEONATAL TPN MIXER
• Manufacturer (Section D): BAXA
• MDR Report Key: 3966502
• MDR Text Key: 21493653
• Report Number: MW5037484
• Device Sequence Number: 1
• Product Code: LHI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/25/2014
• Patient Sequence Number: 1