Infusomat® 362431Recalls & reported problems
B. Braun Medical Inc. · 15 drops/mL, priming volume: 22mL, length: 120in, ULTRASITE® · Class 2
2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04046964294013), received between Jun 5, 2018 and Jun 5, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Infusion or Flow Problem” (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 ↗
- Jun 17, 2024Open, Classified
Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of adverse drug reaction and/or product malfunction with loss of medication/blood.
Z-2383-2024 · Root cause: Process control · FDA record ↗
Most reported problems
Device problems
- Infusion or Flow Problem1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 5, 2018Infusion or Flow Problem; Infusion or Flow Problem
AS REPORTED BY THE USER FACILITY: A LAB WAS BEING DRAWN ON A PATIENT AND THE IV NEEDED TO BE STOPPED. WHEN THE NURSE WENT TO RESTART IT, IT WAS ALARMING. NO ONE NOTICED WHAT THE ALARM WAS FOR, AN OCCLUSION OR AIR BUT THE NURSE TURNED IT OFF SO THAT SHE COULD RETURN A SHORT TIME LATER TO RESOLVE THE ISSUE. IN THE MEANTIME ANOTHER NURSE WENT IN TO RESOLVE THE ISSUE AND FOUND THE TUBING BELOW THE PUMP FULL OF AIR. I HAVE TALKED TO MULTIPLE NURSES AND NO ONE HAS ANY IDEA HOW AIR COULD HAVE GOTTEN INTO THE LINE BELOW THE PUMP. ACCORDING TO THE INCIDENT REPORT THE MAIN BAG HAD 950 MLS IN IT AND THE CEFAZOLIN BAG HAD 25 MLS IN IT. THE NURSE DID CLAMP THE PRIMARY TUBING ABOVE THE PUMP WHEN SHE TURNED IT OFF BUT THE SECONDARY WAS UNCLAMPED AND FLUID IN THE BAG. NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7569147 ↗
Other Set, administration, intravascular devices
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- CADD 21-7302-24Icu Medical, Inc. · Set, administration, intravascular4 recalls1 death4,657 reports
- 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.