MAUDE Adverse Event Report: ELEKTA MOSAIQ 2.60

Device Problems Computer Software Problem (1112); Programming Issue (3014)

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

Event Date 05/31/2016

Event Type  Injury  

Event Description

Oncology medications are dosed according to a pt specific weight or bsa.Asco/ons guidelines recommend ordering these medications by providing a dose basis and a calculated dose for safety reasons.If both numbers are provided, it helps ensure that other disciplines can provide safety checks before the chemotherapy is administered to the pt.When dose adjustment are made, the dose adjustment should be reflected on both the dose basis and the calculated dose.If the change is made on one and not the other, this is a dose error waiting to happen.Elekta's product, mosaiq, allows physicians to make dose adjustments in a preset function (10%, 20%, 25%, 50% reductions); however, the computer only makes the adjustment on the calculated dose.If the provider wants the dose adjustment to reflect on both the dose basis and the calculated dose, the provider has to take extra steps to do so.Elekta states this allows for flexibility.However, it goes against national guidelines on safe oncology prescribing practices.The mfr wants to provide flexibility; however, the computer system does not allow for a default to make the changes in both the dose basis and calculated dose.Our prescribers feel this is unsafe software for dosing chemotherapy and the clinic is moving away from elekta's chemotherapy ordering platform.I am providing the email communication provided by elekta.We inquired with elekta on the possibility in (b)(6) 2015 and there has been no action taken in the last 6 months.From (b)(6) sent on (b)(6) 2016 9:42 am to: (b)(6) subject: re: mosaiq opportunities hi (b)(6), yes, i think we discussed this issue when i was onsite there in (b)(6).I am afraid the only available options in department setup are the following: i have reached out to our product manager for med onc and she has added this to the enhancement request list for you.But unfortunately there isn't a way to default the adjust dose basis check box.Providers will have to continue to check the box manually, or use the little arrow between the dose basis boxes to ensure that the adjusted dose basis appears on the cws and in the order.Hope you had a great memorial day weekend (b)(6).

• Brand Name: MOSAIQ 2.60
• Type of Device: MOSAIQ 2.60
• Manufacturer (Section D): ELEKTA
• MDR Report Key: 5702734
• MDR Text Key: 46823018
• Report Number: MW5062685
• Device Sequence Number: 1
• Product Code: IYE
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 06/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention