—#204211

Product

Sensica Urine Output System, Catalog Number SCCS1002

FDA product code: EXS — Urinometer, Electrical
Device class: Class 2
Medical specialty: Gastroenterology, Urology
Affected lot / code info: UDI/DI 00801741215773, Serial numbers: BMGPRMYS001 , BMGPRMYS003, BMGPRMYS004, BMGPRMYS005, BMGPRMYS006, BMGPRMYS007, BMGPRMYS020, BMGPRMYS026, BMGPRMYS028, BMGPRMYS030, BMFWRMSBT4, BMFWRMSJ45, BMFWRMSJ49, BMFZRMS104, BMGNRMS085, BMFSRMSH98, BMFSRMSJ01, BMFVRMSQ62, BMFVRMSQ66, BMFVRMSQ68, BMFYRMSJ41, BMFYRMSJ49, BMFZRMS067, BMFZRMS070, BMFZRMS080, BMFZRMS113, BMFZRMS117, BMGNRMS070, BMFURMSF02, BMFURMSF04, BMFURMSF14, BMFURMSF21, BMFVRMSQ51, BMFVRMSQ52, BMFVRMSQ54, BMFVRMSQ79, BMFVRMSQ83, BMFVRMSQ89, BMFVRMSQ91, BMFWRSJ46, BMGPRMYS011, BMGPRMYS018, BMGPRMYS022 , BMGPRMYS023, BMGPRMYS027, BMFYRMSJ35, BMFYRMSJ37, BMFYRMSJ54, BMFYRMSJ58, BMGNRMS079, BMGNRMSG69, BMGNRMSG74, BMFSRMSH94, BMFSRMSH99, BMFSRMSJ38, BMFSRMSJ44, BMFTRMS138, BMFSRMSJ13, BMFSRMSJ27, BMFSRMSJ33, BMFSRMSJ34, BMFQRMS248, BMFQRMS250, BMFRRMS646, BMFRRMS647, BMGPRMYS008, BMGPRMYS009, BMGPRMYS010, BMGPRMYS013, BMGPRMYS014, BMGPRMYS016, BMFZRMS073, BMFSRMSH78, BMFSRMSH79, BMFSRMSH80, BMFSRMSH81, BMFSRMSH82, BMFSRMSH83, BMFSRMSH93, BMFSRMSJ00, BMFSRMSJ14, BMFSRMSJ15, BMFQRMS246, BMFWRMSJ39, BMFWRMSJ41, BMFSRMSJ36, BMFSRMSJ37, BMFSRMSJ42, BMFTRMS106, BMFTRMS109, BMFTRMS114, BMFTRMS142, BMFURMSF01, BMFURMSF05, BMFSRMSH95, BMFSRMSH97, BMFTRMS120, BMFTRMS122, BMFTRMS123, BMFTRMS135, BMFTRMS136, BMFTRMS137, BMGPRMYS002, BMGPRMYS012, BMGPRMYS019 , BMGPRMYS029, BMFPRMYS009, BMFQRMS244, BMFQRMS272, BMFQRMS276, BMFQRMS286, BMFQRMS293, BMFSRMSJ43, BMFTRMS121, BMGNRMS067, BMGNRMS076, BMFVRMSQ58, BMFVRMSQ70, BMFVRMSQ73, BMFVRMSQ74, BMFVRMSQ90, BMFVRMSR17, BMFWRMSJ27, BMFWRMSJ35, BMFURMSF06, BMFURMSF09, BMFWRMSJ36, BMFWRMSJ51, BMFZRMS068, BMFQRMS294, BMFZRMS105, BMFSRMSJ20, BMFTRMS140, BMFVRMSQ63, BMFVRMSQ64, BMFVRMSQ65, BMFVRMSQ72, BMFVRMSQ75, BMFVRMSQ76, BMFVRMSQ77, BMFVRMSQ78, BMFVRMSQ80, BMFYRMSJ39, BMFZRMS081, BMFZRMS116, BMGNRMS015, BMGNRMS029, BMGNRMS073

Why it was recalled

BD (C.R. Bard) has received user complaints reporting that when the device was connected to WiFi/Internet, the time displayed on the Sensica device changed during a patient monitoring session which resulted in 1) incorrect time displayed on the monitoring screen, 2) incorrect hour block timestamps on the monitoring screen, 3) incorrect hour timestamps on data screens, and 4) incorrect catheter use time.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

BD (CR Bard) issued an URGENT Medical Device Product Advisory to its consignees on 11/15/2023, via FedEx and email. The notice explained the problem with the device, potential hazard, and requested that the consignee perform Operating System and Sensica Software settings changes per the instructions provided on all devices within your facility s control using the attached directions.

Recalling firm

Firm: C.R. Bard Inc
Address: 8195 Industrial Blvd Ne, Covington, Georgia 30014-1497

Distribution

Distribution pattern: US Nationwide distribution.

Timeline

Recall initiated: 2023-11-15
Posted by FDA: 2023-12-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #204211. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.