—#209490

Product

Infusomat Space Infusion System/ Large Volume Pump, Product Code 8713050U

FDA product code: FRN — Pump, Infusion
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K191910
Affected lot / code info: UDI-DI (GUDID) - 04046963716752 Serial Numbers 52226, 107529, 123259, 123815, 123843, 139003, 147678, 147721, 147725, 239018, 239165, 239231, 239279, 339337

Why it was recalled

Extension of previous recall RES 92978. Pumps have the potential for upstream occlusion sensor to cease proper function due to buildup of electrostatic charge during operation triggering false downstream and upstream occlusion alarms. Additional devices have been affected.

Root cause (FDA determination)

Component design/selection

Action the firm took

On August 7, 2024, the firm notified customers via "URGENT MEDICAL DEVICE CORRECTION" letters which specified that previous recall RES 92978 had been extended to include additional serial numbers as well as one additional model number. The updated serial numbers for the prior models has been documented under RES 92978. This present record documents the addition of model number 8713050U. Customers were instructed to identify affected units in their facilities and to place the provided stickers on impacted units to aid clinical and biomedical staff in identifying units which require sensor exchange and application of interim control measures described in the letter. The firm recommends that consignees use non-impacted devices for the delivery of high-risk medications, and do not use impacted serial numbers for high-risk medications until the upstream occlusion sensor can be replaced. Return the product correction acknowledgement for to B.Braun Medical Inc. Quality Assurance department by faxing the form to (610) 849-1197 or e-mail to PA_QualityAssurance.BBMUS_Service@bbraunusa.com even if the total inventory in your possession is zero (0). A Field Service Representative will contact customers to arrange for a time and date to check their pump and replace their impacted sensors. If you have any questions, contact us at 610-266-0500.

Recalling firm

Firm: B Braun Medical Inc
Address: 200 Boulder Dr, Breinigsville, Pennsylvania 18031-1532

Distribution

Distribution pattern: US distribution to AL, CA, GA, IL, MI, and TX.

Timeline

Recall initiated: 2024-08-07
Posted by FDA: 2024-09-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #209490. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.