B. Braun is removing three lots of its Streamline Bloodline Set for the Dialog+ hemodialysis machine. FDA published an early alert on October 27. The company sent its customer letter on October 20.
A required solvent application was skipped during assembly, so the dialyzer connector did not bond properly. The connector can detach or leak during priming or during dialysis. FDA lists blood loss from the extracorporeal circuit, clotting that forces a circuit replacement, and air entering the circuit, which the machine's air detection should catch but which in extremely rare cases could cause an embolism and death.
Affected product is model SL-2010M2096, lots A2600099, A2600128 and A2600136, under UDI-DIs 04046964367786 and 04046964367779. B. Braun reported no serious injuries or deaths as of October 10 and asks users to quarantine affected inventory and return it.
An omitted solvent step that still passes final inspection is a process validation and in-process control question rather than a design one, which is where a follow-up inspection of a bonded fluid path usually goes.