Infusomat® 480258Recalls & reported problems
B. Braun Medical Inc. · 15 DROP PUMP SET 1 SAFEDAY 0.2 FILTER · Class 2
2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04046955324835), received between Jan 5, 2022 and Nov 13, 2022 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Device Misassembled During Manufacturing /Shipping” (3 reports).
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 Misassembled During Manufacturing /Shipping3
- Leak/Splash3
Patient problems
- No Clinical Signs, Symptoms or Conditions6
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 13, 2022Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: GREEN CLAMP OF PUMP SEGMENT IS ON THE WRONG SIDE OF THE PUMP SEGMENT. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15786260 ↗MalfunctionNov 13, 2022Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: GREEN CLAMP OF PUMP SEGMENT IS ON THE WRONG SIDE OF THE PUMP SEGMENT. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15786259 ↗MalfunctionFeb 23, 2022Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION: GREEN SLIDE CLAMP ON WRONG SIDE OF PUMP SEGMENT. DETAILED INQUIRY DESCRIPTION: WHILE PRIMING, THE NURSE NOTICED THAT THE GREEN CLAMP WAS ON THE WRONG SIDE OF THE PUMP SEGMENT. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13583869 ↗MalfunctionJan 5, 2022Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: EVENT 3: DETAILED INQUIRY DESCRIPTION THE DISTAL FILTERED EXTENSION SET HAS BECOME DISCONNECTED FROM THE PRIMARY PUMP TUBING DURING INFUSION RESULTING IN FLUID SPILLING ON THE PATIENT, FLOOR, NURSES AND IN SEVERAL INSTANCES BLOOD BACK FLOWED FROM PORT RESULTING IN ENVIRONMENTAL EXPOSURE. THE NURSES MENTIONED TIGHTENING THE CONNECTION PRIOR TO PRIMING. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13172997 ↗MalfunctionJan 5, 2022Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: EVENT 1: DETAILED INQUIRY DESCRIPTION: THE DISTAL FILTERED EXTENSION SET HAS BECOME DISCONNECTED FROM THE PRIMARY PUMP TUBING DURING INFUSION RESULTING IN FLUID SPILLING ON THE PATIENT, FLOOR, NURSES AND IN SEVERAL INSTANCES BLOOD BACK FLOWED FROM PORT RESULTING IN ENVIRONMENTAL EXPOSURE. THE NURSES MENTIONED TIGHTENING THE CONNECTION PRIOR TO PRIMING. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13172995 ↗MalfunctionJan 5, 2022Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: EVENT 2: DETAILED INQUIRY DESCRIPTION: THE DISTAL FILTERED EXTENSION SET HAS BECOME DISCONNECTED FROM THE PRIMARY PUMP TUBING DURING INFUSION RESULTING IN FLUID SPILLING ON THE PATIENT, FLOOR, NURSES AND IN SEVERAL INSTANCES BLOOD BACK FLOWED FROM PORT RESULTING IN ENVIRONMENTAL EXPOSURE. THE NURSES MENTIONED TIGHTENING THE CONNECTION PRIOR TO PRIMING. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13172993 ↗
Other Set, administration, intravascular devices
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- Minimed™ Quick-set™ MMT-399AUnomedical A/S · Set, Administration, Intravascular9 deaths8,669 reports
- 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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.