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Recall Observatory FDA recall evidence

Device product

8713052U, Infusomat Large Volume Pump, Non-Wireless BATTERY PACK; Volumetric Infusion Pump System

Z-0124-2024

September 21, 2023

Class I

Product summary

Firm
B. Braun Medical, Inc.
Event
Event 92978
Status
Ongoing
Classification
Class I
Quantity
884
Official record key
device-enforcement:Z-0124-2024

Official wording

Reason: Upstream occlusion alarm may sound when no occlusion exists, and the device will stop pumping. Interruption to the infusion of high-risk medications may lead to hemodynamic instability requiring medical intervention to prevent permanent impairment to body structures or body functions. In some cases, this may be life-threatening or may lead to death.

Code information: UDI-DI: 04046964708626 Serial Numbers: 878498 -881897 ***Update 8/7/24*** Additional SNs 133238, 133975, 490442, 546815, 559325, 561645, 562713, 593049, 617405, 617409, 618522, 783680, 810031

Distribution pattern: Domestic distribution nationwide. Foreign distribution to Canada.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Upstream occlusion alarm may sound when no occlusion exists, and the device will stop pumping. Interruption to the infusion of high-risk medications may lead to hemodynamic instability requiring medical intervention to prevent permanent impairment to body structures or body functions. In some cases, this may be life-threatening or may lead to death.