Infusomat® 362911Recalls & reported problems
B. Braun Medical Inc. · Priming volume: 14mL, length: 84in, CARESITE®, Spin-Lock® · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
1 open recall names 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
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04046964837845), received between Apr 1, 2025 and Apr 1, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Air/Gas in Device” (1 report).
1 FDA recall record name this device's identifier, 1 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
- 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 Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 1, 2025Air/Gas in Device; Air/Gas in Device
AS REPORTED BY THE USER FACILITY: DESCRIBE THE EVENT OR PROBLEM (PLEASE PROVIDE AS MUCH DETAIL AS POSSIBLE): RN ENTERED THE ROOM AT 2030 TO BLINA PUMP BEEPING AIR IN LINE. THIS BUBBLE WAS AROUND 3 INCHES OF TUBING LING. THIS RN WAS ABLE TO FLICK THE AIR BUBBLES OUT AND RESTART THE INFUSION. AT 2045, THE PUMP BEGAN ALARMING AGAIN. UPON INSPECTING THE LINE THIS RN NOTICED THAT THE AIR BUBBLE WAS SIGNIFICANTLY LARGE STRETCHING FROM THE CASSETTE THAT CLIPS INTO THE PUMP TO THE VALVE/Y-SITE ABOVE THE PUMP. THIS RM NOTIFIED THE CHARGE NURSES, H2 PHARMACY, AND THE PRACTITIONER. AFTER MANY ATTEMPTS TO GET RID OF THE AIR AND SWITCHING THE PUMP OUT, THE DECISION WAS MADE TO HANG A NEW BAG OF BLINA. UNSURE IF THIS EVENT WAS RELATED TO BBRAUN TUBING/PUMP OF CURLIN TUBING (YELLOW TAB OF CURLIN BROKE OFF PER DAYSHIFT RN). THIS RN HUNG THE NEW BAG OF BLINA WITH ANOTHER RN AT 2109. TUBING AND PUMP SAVED ON CL OFFICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21741450 ↗
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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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