Infusomat® 363019Recalls & reported problems
B. Braun Medical Inc. · Priming volume: 40mL, length: 123in, SafeLine® · Class 2
2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04046964294198), received between Nov 22, 2016 and Nov 8, 2019 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device Operates Differently Than Expected” (1 report).
2 FDA recall records name this device's identifier, 2 still open.
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.
Recalls naming this device
- Oct 29, 2025Open, Classified
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Z-0640-2026 · Root cause: Process control · FDA record ↗
- Nov 1, 2023Open, Classified
In affected products, the tubing outer diameter may vary in size or the length of tubing may be too short. Both issues may lead to false air-in-line alarms, which will stop the infusion and interrupt therapy. Interruptions or delays in medication administration may result in serious injury to patients which may be life-threatening (e.g. interruption of a vasopressor to a hemodynamically unstable patient) or may lead to death.
Z-0355-2024 · Root cause: Process control · FDA record ↗
Most reported problems
Device problems
- Device Operates Differently Than Expected1
- Fluid/Blood Leak1
Patient problems
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 8, 2019Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: DESCRIPTION OF DEFECT: THERE WAS A TEAR IN THE TUBING JUST BELOW THE DRIP CHAMBER. WHEN THE UNIT OF BLOOD WAS SPIKED AND WHILE ATTEMPTING TO PRIME THE TUBING, BLOOD WAS EXITING THROUGH THE TEAR. THE UNIT OF BLOOD ULTIMATELY NEEDED TO BE DESTROYED. NO INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9295122 ↗MalfunctionNov 22, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected
AS REPORTED BY USER FACILITY: DURING BLOOD TRANSFUSION, LEAKING FROM TOP OF BLOOD FILTER CHAMBER WHERE TUBING COMES INTO THE CHAMBER.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6120507 ↗
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- Autosoft XC 1001681Unomedical A/S · Set, Administration, Intravascular1 death4,216 reports
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.