MAUDE Adverse Event Report: IMPAC MEDICAL SYSTEMS, INC. MOSAIQ; ACCELERATOR, LINEAR, MEDICAL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Overdose (1988)

Event Type  Death  

Manufacturer Narrative

The manufacturer's investigation is still on-going and further information will be provided once the investigation has completed.

Event Description

It was reported by the customer that a medical assistant entered the patients weight as (b)(6) lbs and height as 12050 inches in mosaiq.The bsa and bmi were both flagged yellow by the system.The patient received infusion calculated with this height, which was checked by the pharmacist, physicians and two infusion nurses.The patient went into cardiac arrest and has died.

Manufacturer Narrative

The investigation was completed by conducting a thorough evaluation of the product and the reported information.Mosaiq worked as designed and intended.Mosaiq calculated bsa (body surface area) using the entered height and then capped the bsa at 3.00.Bsa alert limits in observation definitions were set with a warning at 3.00.The system did indicate a warning by highlighting the bsa in yellow on the clinician worksheet.The calculated bsa using the height and weight entered would be 73.40 (dubois dubois).Mosaiq should be configured by the user to show warning levels on height and weight.As the height and weight levels were not configured by the user with additional warning criteria there were no additional warnings presented to the user.The height, weight and bsa are presented to the physician to confirm what information was used in the calculations during the drug approval process.Mosaiq does not prevent an order from being approved based on these warnings.This was a case of abnormal use and the warnings were not observed by the users.

• Brand Name: MOSAIQ
• Type of Device: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): IMPAC MEDICAL SYSTEMS, INC.; 100 mathilda place, 5th floor; sunnyvale CA 94086
• Manufacturer (Section G): IMPAC MEDICAL SYSTEMS, INC.; 13723 riverport drive; suite 100; maryland heights MO 63043
• Manufacturer Contact: pms ; linac house; fleming way; crawley, west sussex RH10 -9RR ; UK RH10 9RR
• MDR Report Key: 5767911
• MDR Text Key: 48712367
• Report Number: 2950347-2016-00032
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141572
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/28/2016
• Initial Date FDA Received: 07/04/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death