8713051U, Infusomat Large Volume Pump, Wireless; Volumetric Infusion Pump System

FDA device recall Z-0123-2024 · posted 2023-10-25 · Open, Classified

Recall details

Recalling firm

B. Braun Medical, Inc.

Reason for recall

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.

Action taken

On September 21, 2023, the firm began notifying customers of the issue via "URGENT MEDICAL DEVICE CORRECTION" letters. BBMI will schedule service to update impacted devices. Customers were provided with stickers to identify affected units while waiting for the service to be completed. In the meantime, customers were informed of measures that may aid in continued use of the pumps, such as only using non-impacted devices for the delivery of high-risk medications and placing the impacted units in care areas that do not administer high risk medications. Customers may contact BBMI by calling 1-800-627-7867 (1-800-627-PUMP) for technical support for potential alternate interim measures. ***Updated 8/7/24*** On August 7, 2024, firm identified additional units which were serviced using potentially impacted sensors. Serial numbers were added to the two models already in scope (Article Numbers 8713051U and 8713052U). Serial numbers from an additional model (Article No. 8713050U) also added and tracked under RES 95093.

Root cause

Component design/selection

Status

Open, Classified

Product code

FRN

Quantity affected

9771

Distribution

Domestic distribution nationwide. Foreign distribution to Canada.

Date initiated

2023-09-21

Date posted

2023-10-25

Location

Allentown, PA

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