Fifty-five injuries and one death have been attributed to Becton Dickinson Alaris infusion pumps, prompting a swift recall of eight different pump systems and their modules from thousands of hospitals and other healthcare facilities that use the pumps. In total, facilities that use over 2.4 million BD Alaris systems and pumps are affected.
The BD Alaris™ pump module delivers often critical medications, fluids, blood, or blood products to patients of all ages.
The U.S. Food and Drug Administration, which regulates the safe use of medical devices, has outlined three potentially fatal reasons, or Class I situations, for recall, as well as a fourth Class II recall situation, which may cause adverse health consequences.
The first Class I Recall is due to damaged inter-unit interfaces, or IUI connectors. This problem results in loss of power or communication between the PC unit and the pump modules. This issue can cause the unit to stop an infusion, which could interrupt therapy or monitoring.
The second Class I Recall is due to broken elements on the module, including the units’ upper hinge posts, lower hinge posts, and possibly the membrane frame on the module. This can result in the pump delivering too much or not enough fluid, or in free-flow of fluid without regulation or an alarm.
The third Class I Recall is due to improperly secured PC unit batteries. This can cause the system to lose power and interrupt infusion therapy or monitoring. When this occurs, the system emits a prolonged alarm that cannot be silenced.
The Class II Recall involves dim LED display on the module, which can appear dim in some segments, resulting in an unclear number display. The numbers provide physicians and nurses with monitoring data important to patient care.
The following Alaris System Infusion Pump models have been recalled:
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- Alaris System PC Unit Model 8000
- Alaris System PC Unit Model 8015
- Alaris Pump Module Model 8100
- Alaris Syringe Module Model 8110
- Alaris PCA Module Model 8120
- Alaris EtCO2 Module Model 8300
- Alaris SpO2 Module Model 8210 and 8220,
- Alaris Auto ID Module Model 8600
These models were manufactured and distributed July 1, 2004 through April 30, 2020.
If you or a loved one has sustained injury or death due to malfunction of an Alaris System Infusion Pump, contact OnderLaw at 314-963-9000. OnderLaw attorneys work hard to hold corporations accountable when they put profits over people, and to stand up for victims of faulty medical devices. Call today for a free, no-obligation consultation. We don’t get paid unless you win your case.
