Safeline (set for blood transfusion)

2019: A withdrawal of tens of thousands of rejected devices because of risk of an infection

In the middle of November, 2019 the B. Braun Medical company withdrew 22 batches of sets for blood transfusion of the USA and Canada. The reason became defects because of which the tightness of set between filters of blood and the trunk is broken. Such leak can delay treatment or lead to blood poisoning.

As a result of B. Braun Medical withdrew 43,000 Y-shaped sets for blood transfusion, including the products Safeline and Outlook Safety which the company made during the period from the middle of June until the end of August, 2019. Defects with violation of tightness was detected because of the arrived complaints and the revealed "internal discrepancies". B. Braun Medical assumed that at best leak will force the nurse to use new set for blood transfusion that will lead to a treatment delay, and at worst will allow microorganisms to get into a blood-groove, threatening with sepsis.

B. Braun Medical is concerned by risk of blood poisoning in the devices

Considering these risks, B. Braun Medical wished to notify clients and urged them to stop immediately use of these products and to contact the customer support department. B. Braun Medical will organize return of devices and suggests to replace them or to compensate cost. Regulatory bodies were notified on defects and on a withdrawal of products, but did not define a risk class yet. Details are available on the website of regulatory bodies. The B. Braun Medical company initiated a withdrawal of defective products on November 15 and addressed health workers 5 days later.

Several months prior to this B. Braun Medical revealed similar defects with violation of tightness in other device, namely in Infusomat Space infuzomata. Regulatory bodies classified the reason of this response as an undesirable event of class 1, i.e. the life-threatening patient.^[1]

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