MAUDE Adverse Event Report: ELEKTA MOSAIQ

Model Number 2.60.311

Device Problems Application Program Problem: Dose Calculation Error (1189); Application Program Problem (2880)

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

Event Date 05/23/2016

Event Type  malfunction  

Event Description

The md saw patient on (b)(6) 2016 and ordered a 25% dose reduction of both medications in her chemotherapy regimen, pemetrexed and carboplatin.The physician intended for the pemetrexed dose basis to be reduced from 500 mg/m2 to 375 mg/m2 and the carboplatin dose basis to be reduced from auc 5 to auc 3.75.The entries made by the prescriber changed the calculated dose but not the dose basis.Pharmacy received the approved orders for pemetrexed and carboplatin.The orders received by pharmacy were pemetrexed 500 mg/m2 (calculated dose 547mg) and carboplatin auc 5 (calculated dose 254 mg).The patient with bsa 1.53 and calculated crcl=39.1ml/min.Pharmacy identified that the pemetrexed dose basis and calculated dose in mosaiq did not match.With that trigger, pharmacy reviewed the last treatment dose administered on (b)(6) 2016 and identified that the physician treated the patient with a reduced dose last cycle.Pharmacy then reviewed the track changes made on (b)(6) 2016 to identify that the prescriber dose adjusted the calculated dose but the computer requires a two step process to also reflect the change on the dose basis.The clinic staff have vocalized their dissatisfaction with this mosaiq feature; however, mosaiq states that the program works as intended and provides flexibility in prescribing documentation.Upon pharmacy review of the carboplatin dose, the dose basis received by pharmacy was auc 5.The patient previously received carboplatin auc 5 on (b)(6) 2016 so pharmacy was not prompted to check the "track changes" feature on (b)(6) 2016 to identify if a dose modification was made.With carboplatin, the ordering dose is often times not close to the calculated dose because computer creatinine clearance is calculated differently than the institutional practice.The computer is also known not to utilize the most up-to-date data when calculating the crcl.Mosaiq utilizes the height, weight, scr from the orders were signed rather than the most recent to the date of treatment.Therefore, the ordering dose of 254mg was not recognized as a dose modification and the pharmacy dispensed carboplatin 320mg.On a related note, the oncology clinic reported to elekta that the dose adjustment functionality does not work for carboplatin dosing in (b)(6) 2015.The 2nd button that is required to be pressed in order to adjust the dose basis when a % dose reduction (only changing the calculated dose) is taken is not a functional button to press.Elekta acknowledged the problem and said it was on their radar.In reviewing ordering corrective action with the prescriber, the carboplatin button is still not working and will not allow the prescriber to reflect the dose adjustment to the dose basis even if he/she tried.This presents the potential for error because the prescriber can not provide the pharmacy with a dose basis and calculated dose to perform a review of the medication order and can result in a medication error.Per asco/ons guidelines for safe prescribing of chemotherapy, the prescriber should be able to provide the intended dose basis and calculated dose.

• Brand Name: MOSAIQ
• Type of Device: MOSAIQ
• Manufacturer (Section D): ELEKTA
• MDR Report Key: 5688301
• MDR Text Key: 46260813
• Report Number: MW5062530
• Device Sequence Number: 1
• Product Code: JQP
• 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: 05/24/2016

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: 2.60.311
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/24/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Weight: 54