Infusomat® 363010Recalls & reported problems
B. Braun Medical Inc. · Priming volume: 21mL, length: 121in, SafeLine® · Class 2
3 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
- 3
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04046964294174), received between Oct 22, 2019 and Oct 22, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Improper Flow or Infusion” (1 report).
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.
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-2385-2024 · 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
- Improper Flow or Infusion1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 22, 2019Improper Flow or Infusion; Improper Flow or Infusion
AS REPORTED BY THE USER FACILITY: DESCRIPTION OF DEFECT: THE IV PUMP ALARMED FOR AN AIR BUBBLE. THE NURSE REMOVED THE TUBING FROM THE PUMP, FLICKED IT TWICE TO SEE/MOVE THE BUBBLE AND THE TUBING FELL APART AT THE CONNECTION OF THE WHITE PLASTIC 'THING' THAT IS USED TO PLACE THE TUBING INTO THE PUMP. NO INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9220481 ↗
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- 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.