Infusomat® 480257Recalls & reported problems
B. Braun Medical Inc. · (60 drops/mL) Universal spike, PE-lined tubing in non-pump segment , free flow protection clamp, roller clamp, SPIN-LOCK® connector. · Class 2
All models of Infusomat (54)
Data updated Oct 16, 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
- 8
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04046955324828), received between Aug 5, 2022 and Oct 8, 2024 — classified as 8 malfunctions.
The most frequently reported specific device problem is “Air/Gas in Device” (4 reports).
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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 · Recall details · FDA record ↗
Most reported problems
Device problems
- Air/Gas in Device4
- Leak/Splash2
- Detachment of Device or Device Component1
- Device Misassembled During Manufacturing /Shipping1
- Free or Unrestricted Flow1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
- Chemical Exposure2
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 8, 2024Leak/Splash; Detachment of Device or Device Component; Leak/Splash; Detachment of Device or Device Component
AS REPORTED, THIS RN TO BEDSIDE TO START ETOPOSIDE CHEMOTHERAPY. PREPARED USING CORRECT PPE WITH CIRCLE PROMING TECHNIQUE WITH CHEMOLOCKS, ATTACHED TUBING TO SECONDARY PORT IN PRIMARY SET (ALSO WITH CHEMOLOCK). SECOND RN DAKOTA TO BEDSIDE TO DOUBLE CHECK/SIGN CHEMO. THIS RN AT THE COMPUTER, (B)(6) RN CHECKING INFORMATION ON BAG AND PUMP FOR SETTINGS. UPON PRESSING START BUTTON ON PUMP, PUMP ALARMED "AIR BUBBLE", SO DAKOTA RN TRIED TO OPEN AIR FILTER ON CHAMBER OF SECONDARY SET TO RESOLVE ISSUE. ENTIRE FILTER, NOT JUST DOOR, POPPED OFF CHAMBER, AND CHEMO WAS SPRAYING DIRECTLY OUT OF SAID PORT. (B)(6) RN DID NOT HAVE GLOVES ON, SEE OTHER WORKFORCE SAFETY E-FEEDBACK. THIS RN GRABBED TUBING WITH GLOVES ON, FOLDED TUBING IN TO CLAMP/PRESSED FINGER ONTO TUBING TO PREVENT FURTHER LEAKING. DAKOTA RN WASHED HANDS THROUGHLY IMMEDIATELY AND WENT TO ASK SARA CHARGE RN TO BRING IN HEMOSTATS TO CLAMP TUBING FURTHER. AREA CLEANED. TUBING AND BAG OF CHEMO PLACED BACK IN HAZARD BAG. NEW BAG OF ETOP REQUESTED UP FROM PHARMACY TO PREP AS SOON AS POSSIBLE.
Patient problems: Chemical Exposure
MAUDE report 20395503 ↗MalfunctionAug 13, 2024Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION VENT FELL OFF DETAILED INQUIRY DESCRIPTION PUMP SET 480257 VENT FELL OFF THE SET. CHEMO SPILL.
Patient problems: Chemical Exposure
MAUDE report 19971506 ↗MalfunctionMar 16, 2023Free or Unrestricted Flow; Free or Unrestricted Flow
AS REPORTED BY THE USER FACILITY: BRIEF DESCRIPTION: TUBING WAS LEAKING AFTER THE LINE WAS PRIMED AND TUBING CLAMP WAS FULLY ENGAGED. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16559168 ↗MalfunctionNov 11, 2022Air/Gas in Device; Air/Gas in Device
AS REPORTED BY THE USER FACILITY: 48 MIN DELAY, PRESSURE, AIR BUBBLES. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15782254 ↗MalfunctionNov 11, 2022Air/Gas in Device; Air/Gas in Device
AS REPORTED BY THE USER FACILITY: KANJINTI INFUSION RAN FINE UNTIL FINE MEDICATION BUBBLES ACCUMULATED AND CAUSED ACCUMULATED AIR IN LINE ALARM. TUBING REMOVED AND BUBBLES "FLICKED" FROM LINE UNTIL LINE CLEAR. PUMP CONTINUED TO ALARM AIR IN LINE AND DID NOT RESOLVE WITH MULTIPLE INTERVENTIONS. SECONDARY TUBING TAKEN OFF PUMP AND ATTACHED TO PORT ABOVE PUMP ON PRIMARY LINE WITH PRIMARY FLUIDS CLAMPED OFF. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15782129 ↗MalfunctionNov 10, 2022Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
AS REPORTED BY THE USER FACILITY: TUBING UPSIDE DOWN. GREEN CLAMP ON UPSIDE DOWN, HOOK DOES NOT FIT IN PUMP. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15769523 ↗MalfunctionNov 8, 2022Air/Gas in Device; Air/Gas in Device
AS REPORTED BY THE USER FACILITY: MULTIPLE ALARMS OF AIR IN LINE, MULTIPLE ATTEMPTS TO FIX THE ISSUES, 20 MINUTES DELAY IN TREATMENT. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15754552 ↗MalfunctionAug 5, 2022Air/Gas in Device; Air/Gas in Device
AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: WHILE RUNNING AN INFLIXIMAB (REFRIGERATED MEDICATION) AT 300ML/HR, THE NURSE NOTED A FIXED, FILM OF MICROMINIATURE BUBBLES LINING THE WALL OF THE TUBING. MULTIPLE AIR BUBBLE ALARMS WERE TRIGGERED, REPEATEDLY INTERRUPTING THE RUNNING INFUSION. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15174947 ↗
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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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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