Infusomat® 490036Recalls & reported problems
B. Braun Medical Inc. · 15 drops/mL, priming volume: 22mL, length: 120in, ULTRASITE® · Class 2
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04046964185908), received between Apr 26, 2017 and Dec 20, 2017 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (3 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Fluid/Blood Leak3
Patient problems
- No Consequences Or Impact To Patient3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 20, 2017Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: THE SET DETACHED AT THE LOWEST Y SITE AT THE BACKCHECK VALVE WHICH CAUSED A SMALL AMOUNT OF BLOOD TO LEAK. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7135619 ↗MalfunctionAug 3, 2017Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: APPROXIMATELY 5 ML OF CHEMOTHERAPY WAS SPILLED. THE CHEMOTHERAPY INVOLVED WAS RITUXIMAB. THE THERAPY HAD BEEN RUNNING FOR ABOUT 2 HOURS WHEN DISCOVERED. DURING A FOLLOW UP CALL WITH THE END USER, IT WAS STATED THAT NO CHEMO DRUG CAME INTO CONTACT WITH PATIENT OR NURSE'S SKIN (THAT WE ARE AWARE OF AT THIS POINT).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6764648 ↗MalfunctionApr 26, 2017Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: CUSTOMER REPORTED THAT THE Y-SITE LEAKED CHEMO DURING USE. NO INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6523202 ↗
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- Autosoft XC 1001681Unomedical A/S · Set, Administration, Intravascular1 death4,216 reports
- Minimed™ Quick-set™ MMT-397AUnomedical A/S · Set, Administration, Intravascular19 deaths4,134 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.