Device product
LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software Suite v2.2 Product No. 17003-02
Z-0966-2026
Product summary
- Event
- Event 98022
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 12 customers
- Official record key
device-enforcement:Z-0966-2026
Official wording
Reason: Software issue only allows Concentration Limits to be defined to one digit of precision past the decimal point (0.1) instead of three digits (0.001). If the user is unable to use Concentration Limits as intended, they may need to change the limits to something other than what is recommended by the drug manufacturer, which may result in over- or under-delivery.
Code information: LifeShield Infusion Safety Software Suite v2.2 UDI-DI 00887709127227
Distribution pattern: US Nationwide distribution in the states of CA, IA, KY, LA, MD, MS, NY, PA, TN, VA.
Derived failure modes
-
Device software or design
Software issue