The FDA issued three notices identifying warnings sent out by ICU Medical‘s Smiths Medical unit related to infusion pump problems.
Smiths Medical warned of issues with some of its CADD-Solis and CADD-Solis VIP ambulatory infusion pumps. The CADD-Solis pump offers utility in hospital or outpatient settings, delivering pain therapies. CADD-Solis VIP pumps are intended for use in a home care setting by patients and/or their caregivers with proper training and clinical support.
On April 10, the company sent affected customers an urgent medical device notification related to each issue. None of the issues require the removal of the devices. The device corrections, however, address issues that could lead to serious injury or death.
To date, the company says it has received zero reports of injury or death related to any of the three separate pump issues.
Smiths Medical warning No. 1: False alarm issue
The company said that it became aware that, under certain conditions, a CADD-Solis pump may trigger a false upstream occlusion (USO) alarm. This erroneous alarm may occur after a delay of more than one hour between the first prime or infusion of a new CADD administration set and the next prime or infusion of the same set.
Smiths Medical said the USO alarm, a high-priority alarm, interrupts an ongoing infusion or delays infusion initiation. The pump can’t resume or start an infusion until the alarm is cleared. Such an alarm may occur if four conditions are met:
- Using a CADD administration set (i.e. not a medication cassette reservoir).
- Enabling the Upstream Occlusion alarm.
- Not programming Keep Vein Open (KVO) or Continuous rate.
- Priming or infusing shortly after attaching the administration set and the next infusion does not occur for approximately one hour or longer.
The issue won’t occur when using a medication cassette reservoir, if the USO alarm is disabled, if the KVO setting is programmed or if a Continuous rate setting is programmed.
Interrupted or delayed therapy can lead to serious patient injury or death, depending on the clinical situation and type of medication.
Warning No. 2: Connection issue
The FDA also issued a notice saying that Smiths Medical warned customers that certain lots of pumps now have updated use instructions. These instructions followed reports of pumps losing communication with the CADD wireless communication module.
This occurrs when wireless network setting changes on the hospital network are not compatible with the CADD wireless communication module. It may result in a “Wireless Module Intermittent Connection” high priority alarm. That alarmstops an ongoing infusion.
If this issue triggers the alarm, the interruption of an active infusion can lead to serious patient injury or death. When the alarm triggers, the pump must be power cycled to clear the alarm.
Smiths Medical said users should validate any wireless network changes or updates to hospital network settings. This ensures compatibility of the wireless connection before deploying network setting changes or updates to the production environment.
The company plans to address this issue with the implementation of a software update.
Warning No. 3: Thermal damage
The final warning relates to three issues associated with the potential for thermal damage in affected pumps. First, Smiths Medical received reports of damage to the circuit board within the housing of a rechargeable battery pack. This may cause the melting of the plastic housing, specifically on the top and bottom surfaces.
Second, the company notes damage to the wireless communication module circuit board. That may cause the melting of the plastic housing of the wireless communication module battery.
Third, Smiths Medical saw damaged or dislodged battery separators or foreign material in the battery compartment. This may cause an electrical short condition between the battery contacts.
Damage to or inoperable batteries can lead to a delay in therapy or interruption of therapy. Users normally receive the “Low Battery” or “Depleted Battery” alarm with this issue. Excessive heat from damaged or shorted components remains a possibility, too, potentially leading to a thermal injury.
Users should visually inspect the external condition of their battery pack or wireless communication module and look for evidence of physical damage. They should never use a battery pack that appears damaged.
