Class I Recall of B. Braun Infusion Pump Battery Packs
In a significant development impacting the medical device industry, the FDA has classified the recent recall of B. Braun Medical’s infusion pump battery packs as Class I. This classification is the most serious level, indicating a situation where there is a reasonable probability that the use of or exposure to the product will cause serious adverse health consequences or death. The recall is not a removal of the product from the market but rather a correction affecting the battery pack used in B. Braun’s Infusomat Space large-volume pump. Both wireless and non-wireless batteries, specifically model numbers 8713051U and 8713052U, are involved in this recall.
The Nature of the Fault and Its Implications
The decision to recall these devices stems from issues identified with the infusion pump system’s occlusion alarms. The malfunction in question involves the alarm sounding erroneously, indicating an occlusion (blockage) when none is present. This false alarm can result in the pump stopping the delivery of medications. Such interruptions are particularly concerning when they involve high-risk medications like vasopressors, which are critical in managing blood pressure and heart function. An unintended stoppage in the delivery of these medications could lead to hemodynamic instability, requiring immediate medical intervention. In extreme cases, this could escalate to life-threatening situations or even result in fatalities.
The Scale of the Recall and Reported Incidents
The recall encompasses a considerable number of devices, with 10,655 units in the U.S. affected. These were distributed within the timeframe from October 26, 2022, to July 17, 2023, with B. Braun initiating the recall on September 21, 2023. The gravity of this recall is further underscored by the reported incidents related to these devices: 51 complaints have been lodged, alongside one injury and one death, directly associated with this issue.
Braun’s Response and Recommendations to Customers
In response to this critical issue, B. Braun has advised its customers to relocate the device for use only in administering low-risk medications. The use of these pumps for high-risk medications has been advised against until the issue is resolved. Furthermore, B. Braun has emphasized the importance of having a secondary pump available for the administration of high-risk medications. To address the malfunction, the company is planning to reach out to customers and send technicians to replace the occlusion pressure sensors with qualified sensors. This action is part of a broader plan for scheduled services intended to update and rectify the affected devices.
This recall is a stark reminder of the crucial role that medical devices play in patient care and the potentially dire consequences when they malfunction. For B. Braun, this recall represents not only a logistical and technical challenge but also a critical juncture in maintaining trust and reliability in their products. The swift and thorough response by the company, in alignment with the FDA’s guidelines, is imperative to ensure patient safety and restore confidence in their infusion pump systems. As the situation evolves, continued vigilance and adherence to safety protocols remain paramount for all stakeholders involved.
CONTACT PARKER WAICHMAN LLP FOR A FREE CASE REVIEW
Parker Waichman LLP helps families recover monetary compensation for harm caused by dangerous products. For your free consultation, contact our national product liability law firm today by using our live chat or calling 1-800-YOUR-LAWYER (1-800-968-7529).
Regardless of your location or where your injury occurred, our nationwide personal injury law firm is ready to assist you.