Infusomat® 362004Recalls & reported problems
B. Braun Medical Inc. · 15 drops/mL, priming volume: 20mL, length: 108in, SafeDAY™ · Class 2
All models of Infusomat (54)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04046964293931), received between Apr 25, 2018 and Feb 17, 2020 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (6 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Fluid/Blood Leak6
Patient problems
- No Consequences Or Impact To Patient5
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 17, 2020Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: "DURING USE ON A PATIENT, THE LINE WAS CONNECTED TO A PRIMARY TUBING AND IT LEAKED AT THE FIRST Y-CONNECTOR ABOVE THE LUER LOCK CONNECTOR. NO INJURY TO THE PATIENT OR USER, JUST WASTE OF CHEMOTHERAPY AGENT." NO INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9716753 ↗MalfunctionApr 25, 2018Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 1: DURING CHEMOTHERAPY THE PRODUCT LEAKED. LIMITED INFORMATION PROVIDED. NO INJURIES REPORTED
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7457921 ↗MalfunctionApr 25, 2018Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 2: DURING CHEMOTHERAPY THE PRODUCT LEAKED. LIMITED INFORMATION PROVIDED. NO INJURIES REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7457916 ↗MalfunctionApr 25, 2018Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 3: DURING CHEMOTHERAPY THE PRODUCT LEAKED. LIMITED INFORMATION PROVIDED. NO INJURIES REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7457915 ↗MalfunctionApr 25, 2018Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 5: DURING CHEMOTHERAPY THE PRODUCT LEAKED. LIMITED INFORMATION PROVIDED. NO INJURIES REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7457913 ↗MalfunctionApr 25, 2018Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 4: DURING CHEMOTHERAPY THE PRODUCT LEAKED. LIMITED INFORMATION PROVIDED. NO INJURIES REPORTED
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7457912 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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