FDA Adverse Event Death Summary report: N

ZIMMER BIOMET INTELLICART SYSTEM

MDR report key: 24556871 · Received March 9, 2026

Report

Report Number
MW5184960
Event Type
Death
Date Received
March 9, 2026
Date of Event
February 16, 2026
Report Date
March 4, 2026
Manufacturer
ZIMMER SURGICAL, INC.
Product Code
JCX
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
OK, US
Reporter Occupation
NURSE
Health Professional
Yes

Narratives

Description of Event or Problem · 0

DURING A LIVER TRANSPLANT SURGERY, THE CZIMMER BIOMET INTELLICART SYSTEM SUCTION MACHINES KEPT FAILING. THIS PATIENT WAS CRITICALLY ILL AND AN ACTIVE MASSIVE TRANSFUSION PROTOCOL FOR NEARLY 12 HOURS. DURING THE CASE, THE MACHINES WOULD LOSE SUCTION; HOWEVER, NO ERROR MESSAGE WAS DISPLAYED ON THESE DEVICES THAT WOULD ALERT SURGICAL STAFF/PHYSICIANS THAT THE SUCTION WAS NO LONGER WORKING OR STATING A LOSS OF SUCTION AT ANY TIME. WHEN OBSERVING THE MACHINES TO TROUBLESHOOT, THE MACHINES UNITS/CANISTERS WERE NOT FULL. THE MANIFOLDS WERE SWITCHED OUT MULTIPLE TIMES IN AN EFFORT TO REGAIN SUCTION, AS WELL. THIS WOULD HELP FOR A SHORT TIME, BUT THE CZIMMER SUCTION MACHINE WOULD ULTIMATELY STOP SUCTIONING. THE STAFF WENT THROUGH 8 DIFFERENT DEVICES OVER THE COURSE OF THIS PATIENT'S OPERATIVE COURSE. IT IS ALSO IMPORTANT TO NOTE, THAT THE PHYSICIANS WERE VERBALLY EXPRESSING THE PATIENT WAS NOT CLOTTING, SO IT'S DIFFICULT TO DETERMINE IF CLOTTING BLOOD WAS THE CAUSE OF SUCTION FAILURE. PATIENT WAS STATUS POST LIVER TRANSPLANT IN 2012. MULTIPLE LIVER/BILIARY ISSUES REQUIRING BILIARY DRAINS, ERCPS (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY), ETC. PT CODES: 4440, 1888. DEVICE CODE: 2170. REFERENCE REPORTS: MW5184955, MW5184956, MW5184957, MW5184958, MW5184959, MW5184961, MW5184962.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
615064 ZIMMER BIOMET INTELLICART SYSTEM APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED JCX ZIMMER SURGICAL, INC.

Patients

Seq Age Sex Outcome Treatment
1 37 YR Female Death