FDA Adverse Event Malfunction Summary report: N

ICU MEDICAL, INC.

MDR report key: 24884472 · Received April 15, 2026

Report

Report Number
24884472
Event Type
Malfunction
Date Received
April 15, 2026
Date of Event
April 8, 2026
Report Date
April 9, 2026
Manufacturer
ICU MEDICAL, INC.
Product Code
FRN
Product Problem
Yes
Report Source
User Facility report
Reporter Location
TN
Reporter Occupation
RISK MANAGER
Health Professional
N

Narratives

Description of Event or Problem · 0

SERIAL NUMBER: (B)(6). PT'S PUMP WAS ALARMING, AND WHEN I ATTEMPTED TO FIX THE ISSUE, THE TOUCH SCREEN WOULD NOT WORK. IT DID NOT MATTER HOW MANY TIMES I TRIED; IT WOULD NOT CLICK THE OK BUTTON. EVENTUALLY, I HAD TO OPEN THE CASSETTE DOOR ON BOTH SIDES TO MAKE IT UNFREEZE. 3MINUTES OF DOWN TIME. SERIAL NUMBER: (B)(6). PUMP WOULD NOT UNLOCK. TRIED SWIPING AND TAPPING BUT WOULD NOT UNLOCK. HAD TO TURN OFF AND ON TWICE. ALSO KEPT GETTING DOWNSTREAM OCCLUSIONS PRIOR TO UNLOCK ISSUE. WOULD NOT MOVE PAST THE ERROR SCREEN AND HAD TO TURN OFF TO GET IT TO RESOLVE. PUMP TAKEN OUT OF SERVICE. TAGGED AND CALLED BIOMED. SERIAL NUMBER: (B)(6). LEFT SIDE PLUM DUO WAS STOPPED AFTER NOREPINEPHRINE WAS CLEARED FROM SECONDARY PROGRAMMING. IN THE STOPPED MODE WHILE NO ACTION WAS RECEIVED, PLUM DUO ALARMED FOR BEING STOPPED FOR MORE THAN 2 MINUTES WHILE OTHER PATIENT CARE WAS TAKING PLACE. "ACTION REQUIRED" ALARM COULD NOT BE CLEARED FROM PUMP TOUCH SCREEN, "SLIDE TO UNLOCK" FEATURE BY MULTIPLE ATTEMPTS FROM MULTIPLE FINGERS, GLOVED AND NON-GLOVED. NEW IV PLUM DUO PUMP WAS OBTAINED. ALARM DID SELF-CLEAR SEVERAL MINUTES LATER, BUT EVENT DELAYED THE NOREPINEPHRINE BEING SET UP. THE PATIENT HAD NOT NEEDED THE NOREPINEPHRINE AT THE TIME OF EVENT BUT DID IT SEVERAL MINUTES LATER. SERIAL NUMBER: (B)(6). NEW ICU MEDICAL PLUM DUO PUMP HAD FAULTY TOUCH SCREEN. IT TOOK APPROXIMATELY 6 ATTEMPTS TO GET IT TO UNLOCK, AND THEN IT WOULD NOT REGISTER KEYSTROKES WITH THE NUMERIC KEYPAD USED WHEN PROGRAMMING VTBI. PT WAS ON MAXIMUM DOSE CLEVIPREX AND ESMOLOL FOR AN ACUTE, SYMPTOMATIC AORTIC DISSECTION SERIAL NUMBER: UNKNOWN. NEW IV PUMP SCREEN FROZE UP. HAD TO FORCE A RESTART BY HOLDING POWER BUTTON. IT TOOK ABOUT 1 TO 2 MIN TO GET THE PUMP RESTARTED. THIS WAS NOT A SAFETY ISSUE BECAUSE IT WAS JUST IVF RUNNING BUT IF THIS WAS A DIFFERENT MEDICATION THIS COULD CAUSE HUGE SAFETY ISSUES.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
943085 ICU MEDICAL, INC. PUMP, INFUSION FRN ICU MEDICAL, INC. 400020403

Patients

Seq Age Sex Outcome Treatment
1 NA Unknown Other