MAUDE Adverse Event Report: B. BRAUN MEDICAL INC APEX; COMPOUNDER

Model Number AX1000

Device Problem Application Program Problem: Dose Calculation Error (1189)

Patient Problem No Patient Involvement (2645)

Event Date 01/25/2019

Event Type  malfunction  

Manufacturer Narrative

This report has been identified as b.Braun medical inc.Internal report number (b)(4).The investigation is ongoing at this time.A follow up will be submitted when the investigation results become available.

Event Description

As per b.Braun implementation specialist: customer reported while compounding an order the pharmacist noticed mvi dispensing out of sequence.Mvi was located on port 19 and should have dispensed fourth in the sequence.The pump was immediately shut down and the bag was scrapped.There was no reported patient injury.

Manufacturer Narrative

This report has been identified as b.Braun medical inc.Internal report number (b)(4).Logs were received for evaluation.The log review confirms an occurrence of a dispense out of sequence.However, after further investigation the following was noted: 1) the user loaded the superset template with station 19, infuvite, in the fourth position on the micro channel.2) the user accidentally cleared-and-closed station 19, removing it from the setup and the sequence.3) the user then re-added station 19, which brings it to the last position in the sequence, since they were not loading it as a pre-sequenced template this time.The current setup was then using the "modified" template.When this happens, the apex system does not attempt to make any judgement calls about where the solution "used to be" in the sequence and subsequently requires sequence approval to occur again.The sequence was confirmed in this manner.To summarize, after clearing and closing station 19, then adding it back into the transfer set/template the sequence for station 19 was never adjusted.Therefore, station 19 stayed last on the sequence screen.Upon making any changes to the template, the sequence needs to be updated as well.B.Braun's recommendation to check sequences after setup approval would be to go into options>transfer set>view setup>sequence approval.If additional pertinent information becomes available a follow-up report will be filed.

• Brand Name: APEX
• Type of Device: COMPOUNDER
• Manufacturer (Section D): B. BRAUN MEDICAL INC; 1601 wallace drive, suite 150; carrollton TX 75006 6690
• MDR Report Key: 9699250
• MDR Text Key: 187073049
• Report Number: 1641965-2020-00004
• Device Sequence Number: 1
• Product Code: NEP
• UDI-Device Identifier: 04046955048502
• UDI-Public: (01)04046955048502
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/07/2020

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?: Yes
• Device Operator: Health Professional
• Device Model Number: AX1000
• Device Catalogue Number: AX1000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/25/2020
• Initial Date FDA Received: 02/12/2020
• Supplement Dates Manufacturer Received: 01/25/2020
• Supplement Dates FDA Received: 04/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1