icu medical, inc.

Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a soft limit violation before confirming and starting delivery. This may potentially lead to under- or over-delivery.

Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a soft limit violation before confirming and starting delivery. This may potentially lead to under- or over-delivery.

Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a soft limit violation before confirming and starting delivery. This may potentially lead to under- or over-delivery.

Oncology sets/closed system transfer devices with extension sets may leak resulting in therapy delayed if noticed and corrected during setup, but if the leak occurs during therapy this may result in therapy interruption with the potential for the patient to receive less infusion solution than intended. Exposure of hazardous substances to the patient, caregiver, or pharmacy technician is possible.

Needle free access device intended as accessory to vascular access used in hemodialysis or accessory to intravascular administration sets has a silicone seal which may bulge at the top, separate from the body, tear; may result in fluid leaks, occluded fluid flow, inability to inject/withdraw blood product, delayed/interrupted therapy, exposure to biological contaminants, air infused into the body

Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the downstream line after a piggyback therapy. The programmed flush volume is delivered from the primary line container at the piggyback therapy rate after the piggyback therapy is complete. In certain cases, as described below, the clinician may receive an Upper Hard Limit (UHL) or Lower Hard Limit (LHL) Violation message when programming a piggyback flush, which prevents the flush from being programmed.

Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the downstream line after a piggyback therapy. The programmed flush volume is delivered from the primary line container at the piggyback therapy rate after the piggyback therapy is complete. In certain cases, as described below, the clinician may receive an Upper Hard Limit (UHL) or Lower Hard Limit (LHL) Violation message when programming a piggyback flush, which prevents the flush from being programmed.

ICU Medical received one lot of defective primary speakers from our supplier that may fail to produce an audible sound. If the primary speaker in your Plum Duo Infusion Pump fails, the pump may not produce audible alarms, alerts, or provide audible feedback for touchscreen inputs.

Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the downstream line after a piggyback therapy. The programmed flush volume is delivered from the primary line container at the piggyback therapy rate after the piggyback therapy is complete. In certain cases, as described below, the clinician may receive an Upper Hard Limit (UHL) or Lower Hard Limit (LHL) Violation message when programming a piggyback flush, which prevents the flush from being programmed.

For certain customers, the Change Summary review option ceases to operate as expected for any migrated library after the migration has been completed. Users must use alternate methods to review changes. Failure to do so may lead in over delivery, under delivery, or delay in setup on the infusion pump.

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.

IV Gravity burette administration set burette component is missing an internal shutoff valve intended to stop fluid flow, which if used may result in delay in therapy during setup, over delivery/unrestricted flow, or air may be infused into the body.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Port weld of drug transfer device may separate or break during use and potentially result in a leak.