Infusomat® 363424Recalls & reported problems
B. Braun Medical Inc. · UNIV. 15 DR PUMP SET, 1.2FIL, 2CRSTE ASV · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
3 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 3
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04046964837906), received between Oct 10, 2024 and Oct 10, 2024 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Air/Gas in Device” (4 reports).
3 FDA recall records name this device's identifier, 3 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.
Reports received per month
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-2391-2024 · 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
- Air/Gas in Device4
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 10, 2024Air/Gas in Device; Air/Gas in Device
AS REPORTED, EVENT 1 : THE STAFF WHO USED THIS PRODUCT CHANGED IT 4 TIMES WITH THE SAME LOT NUMBER. THE USUAL TROUBLESHOOTING WAS FOLLOWED FOR AIR BUBBLES IN THE TUBING, TRIED A DIFFERENT IV PUMP, BUT NO SUCCESS. A DIFFERENT IV TUBING, WITH A DIFFERENT LOT NUMBER RESOLVED THE PROBLEM ON THE FIRST ATTEMPT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20416718 ↗MalfunctionOct 10, 2024Air/Gas in Device; Air/Gas in Device
AS REPORTED, EVENT 2: THE STAFF WHO USED THIS PRODUCT CHANGED IT 4 TIMES WITH THE SAME LOT NUMBER. THE USUAL TROUBLESHOOTING WAS FOLLOWED FOR AIR BUBBLES IN THE TUBING, TRIED A DIFFERENT IV PUMP, BUT NO SUCCESS. A DIFFERENT IV TUBING, WITH A DIFFERENT LOT NUMBER RESOLVED THE PROBLEM ON THE FIRST ATTEMPT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20416712 ↗MalfunctionOct 10, 2024Air/Gas in Device; Air/Gas in Device
AS REPORTED, EVENT 3: THE STAFF WHO USED THIS PRODUCT CHANGED IT 4 TIMES WITH THE SAME LOT NUMBER. THE USUAL TROUBLESHOOTING WAS FOLLOWED FOR AIR BUBBLES IN THE TUBING, TRIED A DIFFERENT IV PUMP, BUT NO SUCCESS. A DIFFERENT IV TUBING, WITH A DIFFERENT LOT NUMBER RESOLVED THE PROBLEM ON THE FIRST ATTEMPT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20416711 ↗MalfunctionOct 10, 2024Air/Gas in Device; Air/Gas in Device
AS REPORTED, EVENT 4, THE STAFF WHO USED THIS PRODUCT CHANGED IT 4 TIMES WITH THE SAME LOT NUMBER. THE USUAL TROUBLESHOOTING WAS FOLLOWED FOR AIR BUBBLES IN THE TUBING, TRIED A DIFFERENT IV PUMP, BUT NO SUCCESS. A DIFFERENT IV TUBING, WITH A DIFFERENT LOT NUMBER RESOLVED THE PROBLEM ON THE FIRST ATTEMPT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20416710 ↗
Other Set, administration, intravascular devices
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- Medtronic Extended MMT-431AUnomedical A/S · Set, Administration, Intravascular3 deaths8,574 reports
- MiniMed™ Mio™ Advance MMT-242AUnomedical A/S · Set, Administration, Intravascular15 deaths8,164 reports
- 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 and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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