Infusomat® 490037Recalls & reported problems
B. Braun Medical Inc. · Priming volume: 24mL, length: 130in · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This B. Braun Infusomat administration set is used to deliver IV fluids and drugs. Most of the 71 reports describe leaking or splashing from the tubing, air getting into the line, and pumps alarming because of that air, which can interrupt infusions. No deaths and no injuries are reported. One recall, started in November 2023, remains open; it says tubing dimensions may vary or tubing may be too short, which can trigger false air-in-line alarms that stop the infusion.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 71
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 71 adverse event reports that list this exact device (DI 04046964185922), received between May 1, 2019 and Jul 6, 2026 — classified as 71 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (42 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. 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
- Leak/Splash42
- Air/Gas in Device16
- Fluid/Blood Leak9
- Adverse Event Without Identified Device or Use Problem2
- Device Alarm System2
- Patient-Device Incompatibility2
- Device Misassembled During Manufacturing /Shipping1
- Improper Flow or Infusion1
Patient problems
- No Clinical Signs, Symptoms or Conditions66
- Hypersensitivity/Allergic reaction2
- No Known Impact Or Consequence To Patient2
- Chemical Exposure1
Recent adverse event reports
The 25 most recent of 71 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 6, 2026Leak/Splash
AS REPORTED BY THE USER FACILITY: THE RED CLAMP ON DRIP CHAMBER WAS IN OPEN POSITION AND CHEMO LEAKED OUT BECAUSE IT WASN'T CLOSED DURING COMPOUNDING. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25717517 ↗MalfunctionMar 5, 2026Air/Gas in Device
AS REPORTED BY THE USER FACILITY: END USER REPORTED ON THE CALL MULTIPLE EVENTS/INCREASE IN EVENTS OF STAFF NOTICING AIR IN LINE DISTAL TO THE PUMP EVEN AFTER PUMP IS PRIMED AND APPEARS TO BE FREE OF AIR, STAFF WILL REENTER THE ROOM WHILE INFUSION HAS BEEN INFUSING AND WILL NOTICE AIR IN LINE. NCH EXPRESSED CONCERNS, UNABLE TO IDENTIFY WHERE AIR IS COMING FROM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24526561 ↗MalfunctionFeb 26, 2026Device Alarm System
AS REPORTED BY THE USER FACILITY: RN COMPLAINED OF AIL, WITH NO BUBBLES VISIBLE. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24460649 ↗MalfunctionSep 2, 2025Air/Gas in Device; Air/Gas in Device
AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: THE AIR BUBBLE ISSUE HAS BEEN MUCH IMPROVED; HOWEVER, STAFF HAVE NOTICED THE TUBING WE UTILIZE FOR CONTROLLED SUBSTANCES HAS HAD SOME INCREASED ISSUES WITH AIR BUBBLES RECENTLY (UNABLE TO RESOLVE VIA TROUBLE SHOOTING THROUGH THE TYPICAL MEANS).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22947965 ↗MalfunctionAug 29, 2025Air/Gas in Device; Air/Gas in Device
AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: AFTER ADMITTING HIM, I HUNG A BAG OF UNASYN. WHEN IT WAS DONE, THE IV PUMP BEGAN BEEPING LOUDLY. I TOOK IT DOWN AND HUNG HIS CONTINUOUS FLUIDS. ABOUT TWO HOURS LATER, THE IV PUMP BEGAN BEEPING LOUDLY. "DOWNSTREAM OCCLUSION", BECAUSE OF AIR IN THE CARTRIDGE. I CLAMPED THE TUBING AND OPENED THE PUMP DOOR. IT BEEPED LOUDLY. I RESTARTED HIS FLUIDS AND Y-SITED IV TYLENOL. 15 MINUTES LATER THE IV PUMP BEGAN BEEPING LOUDLY. I STOPPED THE TYLENOL. ABOUT AN HOUR LATER, THE IV PUMP BEGAN BEEPING LOUDLY. "DOWNSTREAM OCCLUSION", BECAUSE OF AIR IN THE CARTRIDGE. I CLAMPED THE TUBING AND OPENED THE PUMP DOOR. IT BEEPED LOUDLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22923862 ↗MalfunctionAug 29, 2025Air/Gas in Device; Air/Gas in Device
AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: ISSUE REPORTED TO HAVE OCCURRED ON (B)(6) BETWEEN 12-5 AM IN (B)(6) ON PPHP8 MED SURG UNIT. THE MEDICATION WAS UNASYN. AFTER HANGING THE BAG, THE "DOWNSTREAM OCCLUSION" ALARM STARTED FROM AIR IN THE CARTRIDGE. THIS ALARM OCCURRED MULTIPLE TIMES THROUGHOUT THE NIGHT. THE 2ND MEDICATION WAS IV TYLENOL AT THE YSITE. THE ALARMS FOR "DOWNSTREAM OCCLUSION" OFTEN OCCUR DUE TO MICRO-BUBBLES ACCUMULATING IN THE TUBING, WHICH THEN CONVERGE INTO LARGER BUBBLES AND TRIGGER THE ALARM. THIS IS PARTICULARLY PROBLEMATIC WITH CERTAIN TRANSFUSIONS LIKE BLOOD, VANCO, AND EXTENDED ZOSYN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22923765 ↗MalfunctionAug 29, 2025Air/Gas in Device; Air/Gas in Device
AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: THE AIR BUBBLE ISSUE HAS BEEN MUCH IMPROVED; HOWEVER, STAFF HAVE NOTICED THE TUBING WE UTILIZE FOR CONTROLLED SUBSTANCES HAS HAD SOME INCREASED ISSUES WITH AIR BUBBLES RECENTLY (UNABLE TO RESOLVE VIA TROUBLE SHOOTING THROUGH THE TYPICAL MEANS).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22923644 ↗MalfunctionAug 29, 2025Air/Gas in Device; Air/Gas in Device
AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: ISSUE REPORTED TO HAVE OCCURRED ON AUGUST 5TH BETWEEN 12-5 AM IN BETHLEHEM ON PPHP8 MED SURG UNIT. THE MEDICATION WAS UNASYN. AFTER HANGING THE BAG, THE "DOWNSTREAM OCCLUSION" ALARM STARTED FROM AIR IN THE CARTRIDGE. THIS ALARM OCCURRED MULTIPLE TIMES THROUGHOUT THE NIGHT. THE 2ND MEDICATION WAS IV TYLENOL AT THE YSITE. THE ALARMS FOR "DOWNSTREAM OCCLUSION" OFTEN OCCUR DUE TO MICRO-BUBBLES ACCUMULATING IN THE TUBING, WHICH THEN CONVERGE INTO LARGER BUBBLES AND TRIGGER THE ALARM. THIS IS PARTICULARLY PROBLEMATIC WITH CERTAIN TRANSFUSIONS LIKE BLOOD, VANCO, AND EXTENDED ZOSYN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22923629 ↗MalfunctionJul 23, 2024Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION TUBING LEAKED DETAILED INQUIRY DESCRIPTION 490037 RED VENT OPEN OUT OF PACKAGE LEAKED CHEMO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19804781 ↗MalfunctionJul 22, 2024Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem
AS REPORTED BY THE USER FAICLITY: EVENT 1 (B)(6) MEDICAL CENTER PATIENT PRESENTED FOR TAXOL. 1330-PT STARTED THE TAXOL INFUSION. 1342-PT STARTED TO HAVE FACIAL FLUSHING, LEG PAIN, CHEST PAIN, DIFFICULTY BREATHING. INFUSION WAS STOPPED. EMERGENCY MEDICATIONS WERE PROVIDED. MD WAS CALLED IN IMMEDIATELY.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 19792166 ↗MalfunctionJul 22, 2024Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem
AS REPORTED BY THE USER FACILITY: EVENT 2 (B)(6) MEDICAL CENTER 1205-TAXOL STARTED TO RUN AT 40 ML/HOUR FOR 5 MINUTES 1210-PT'S FACE TURNED RED, BEGAN TO SCREAM IN PAIN INDICATING HER BACK, STOMACH AND CHEST. INFUSION STOPPED, EMERGENCY MEDICATIONS WERE GIVEN. MD WAS MADE AWARE.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 19792082 ↗MalfunctionJun 7, 2024Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: PHARMACIST REPORTED LEAKAGE OF THE UNIVERSAL 60 DROP NITRO PUMP SET WITH LOT # 0061906429. THERE WAS NOT PATIENT INJURIES. THE LEAKAGE WAS DISCOVERED AN HOUR INTO THE INFUSION AND 50ML WAS NOTED TO HAVE LEAKED. THE DEVICE WAS INFUSING TAXOL AT THE TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19490219 ↗MalfunctionMay 24, 2024Leak/Splash; Leak/Splash
ACCORDING TO THE EVENT DESCRIPTION: THE UNIVERSAL 60 DROP NITRO PUMP SET, PART # 490037, IS LEAKING FROM THE DRIP CHAMBER. CUSTOMER NOTED A COUPLE OF DEVICES LEAKING IN THIS MANNER. ALSO LEAKING FROM THE END WHERE IT WOULD ATTACH TO THE CLOSED SYSTEM ON THE DEVICE. ONE OF THESE DEVICES WAS NOTED TO BE LEAKING AND ALSO NOTED TO HAVE BLOOD THAT BACKED UP IN THE LINE. NO LOT NUMBER IS AVAILABLE. ONE OF THE UNIVERSAL 60 DROP NITRO PUMP SET, PART # 490037 DEVICES HAD A 50 ML SPILL AFTER ABOUT AN HOUR INTO THE INFUSION; PHARMACIST ASSUMING IT WAS A SLOW LEAK. THEY HAD TO ESTIMATE THE REMAINING DOSE AND REMADE THE PATIENT MEDS WITH ANOTHER BAG. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19392424 ↗MalfunctionMay 20, 2024Leak/Splash; Air/Gas in Device; Leak/Splash; Air/Gas in Device
AS REPORTED BY USER FACILITY: PATIENT NOTED IV LINE TO BE LEAKING WITHIN A FEW MINUTES (5.6ML) OF ETOPOSIDE INFUSION. INFUSION PAUSED AND LOW SORBING LINE EXAMINED. LEAKING OCCURRED AT CONNECTION POINT BETWEEN END OF TUBING AND START OF LEUR LOCK PIECE. CRACK OR BUBBLE NOTICED AT THIS POINT.DR. (B)(6) MADE AWARE AND OK WITH LOSING APPROX 10 ML OF ETOPOSIDE (OF 600 TOTAL ML) IN LINE IN ORDER TO PRIME A NEW LINE AND CONTINUE INFUSION. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19355620 ↗MalfunctionFeb 29, 2024Air/Gas in Device; Air/Gas in Device
AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION: REPEATED AIR IN LINE ALARMS WITH UPDATED TUBING. DETAILED INQUIRY DESCRIPTION: THE FOLLOWING STATEMENT IS DIRECTLY FROM THE CUSTOMER'S EMAIL: IN THE LAST 48 HOURS WE HAVE HUNG 20 DIFFERENT IMMUNOTHERAPY INFUSIONS. OUT OF 20 INFUSIONS, ONLY ONE HAS BEEN ABLE TO RUN WITHOUT THE "AIR IN LINE" ALARM. WE HAVE CONFIRMED WITH PHARMACY THAT THEY ARE USING THE NEW TUBING AS WELL. THE ONLY WAY WE ARE CURRENTLY ABLE TO MAKE THE PUMPS WORK IS TO USE ULTRASOUND GEL ON THE TUBING WHERE THE AIR SENSOR IS. THAT'S THE ONLY WAY WE ARE ABLE TO COMPLETE THE INFUSIONS. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18806834 ↗MalfunctionFeb 23, 2024Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: 490037: LEAKING CHEMO OUT OF RED FILTER BY DRIP CHAMBER. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18767246 ↗MalfunctionFeb 14, 2024Air/Gas in Device; Air/Gas in Device
AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION MULTIPLE AIR IN LINE ALARMS. DETAILED INQUIRY DESCRIPTION AILS NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18705232 ↗MalfunctionJan 24, 2024Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: CHEMOTHERAPY TAXOL WITH B. BRAUN TUBING AND FILTER LEAKING AT CONNECTION SITE. PATIENT NOTICED WET SPOTS ON THE FLOOR UPON RETURNING BACK FROM BATHROOM. CHEMO STOPPED AND INSPECTED ALL IV TUBING CONNECTIONS, ALL INTACT AND TIGHT. RESTARTED INFUSION AND NOTICED LEAKING COMING FROM FILTER CONNECTION AND TAXOL TUBING. TAXOL DISCONNECTED AND GIVEN TO PHARMACY. REPLACED FAULTY TUBING AND FILTER AND RESTARTED INFUSION WITH REMAINDER OF VOLUME. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18574204 ↗MalfunctionDec 9, 2023Air/Gas in Device; Air/Gas in Device
AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION: DEFECTIVE IV PUMP TUBING. DETAILED INQUIRY DESCRIPTION: SET 490037- AIR IN LINE DURING USE. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18298206 ↗MalfunctionNov 6, 2023Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: DESCRIPTION AS REPORTED: PER CUSTOMER, "STAFF EXPERIENCED A LEAK WHEN ADMINISTERING CHEMO." NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18078615 ↗MalfunctionSep 21, 2023Device Alarm System; Leak/Splash; Device Alarm System; Leak/Splash
AS REPORTED BY THE USER FACILITY: DETAILS OF COMPLAINT (REPORTED ISSUE): WHEN CIRCLE PRIMING ETOPOSIDE USING THE LOW ADSORPTION SET (REF 490037), LOT 0061870727, THE HIGH VOLUME PUMP GAVE ERROR " HIGH DOWNSTREAM PRESSURE". A FILTER (0.2UM) (PRODUCT CODE PF2000, LOT GR00013070) WAS ATTACHED TO THE END OF THE LINE, ATTACHED TO THE PHASEAL, ATTACHED TO THE BAG (FOR CIRCLE PRIMING). ALL CONNECTIONS WERE CHECKED, AND RECONNECTED, TO ENSURE THAT THE CONNECTIONS WEREN'T CONTRIBUTING TO THE HIGH PRESSURE ERROR. DUE TO UNSUCCESSFUL ATTEMPT TO WORK THROUGH THE ERROR AND FINISH PRIMING THE LINE SUCCESSFULLY, THE LINE WAS TRANSFERRED TO A DIFFERENT HIGH VOLUME PUMP. THIS ALLOWED FOR SUCCESSFUL PRIMING, HOWEVER A NEW ERROR STARTED TO OCCUR; THE PUMP INDICATED "AIR BUBBLE" WAS CONTRIBUTING TO THE STOP ERROR. AFTER SEVERAL ATTEMPTS TO CLEAR THE AIR BUBBLE, THE ERROR WAS PERSISTENT, SO THE LINE WAS TRANSFERRED BACK TO THE ORIGINAL HIGH VOLUME PUMP, WHICH THEN CONTINUED TO GIVE THE "AIR BUBBLE" ERROR. A THIRD HIGH VOLUME PUMP WAS USED, WHICH ALSO INDICATED THE "AIR BUBBLE" STOP ERROR. WE THEN DECIDED TO CHANGE THE LOW ADSORPTION SET (THE LINE). WE DID THIS BY UNSPIKING THE ETOPOSIDE AND INSTEAD, IN
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17788412 ↗MalfunctionSep 14, 2023Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION CHEMO SPILL. CONNECTION LEAKED DOESN'T STAY ON PER RN. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17744206 ↗MalfunctionSep 12, 2023Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: DETAILS OF COMPLAINT (REPORTED ISSUE): PT DUE TO RECEIVE ETOPOSIDE. ETOPOSIDE REQUIRED TO BE DELIVERED VIA LOW ABSORPTION TUBING, CONNECTED TO A FILTER, AND THEN B BRAUN CLOSED SYSTEM. WHILE CIRCLE PRIMING ETOPOSIDE LEAK NOTED BETWEEN FILTER AND LINE. FILTER CHANGED, ORIGINAL FILTER HAD LOT NUMBER 0061861821. PROBLEM RECURRED WITH NEW FILTER. AFTER REPLACING FILTER, LINE WAS CHANGED. AFTER REPLACING LINE AND REPRIMING TUBING PROBLEM RESOLVED AND WAS ABLE TO ADMINISTER ETOPOSIDE TO PATIENT. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17728741 ↗MalfunctionSep 11, 2023Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: DETAILS OF COMPLAINT (REPORTED ISSUE): END USER FOUND PATIENT'S BED SHEET AND T SHIRT WET. ETOPOSIDE WAS INFUSING FOR APPROX 1 HOUR. WRITER FOUND VISIBLE DROPS COMING FROM FILTER CONNECTION WHEN INVESTIGATING IF LEAK WAS OCCURRING. INFUSION PAUSED, BED SHEET CHANGED AND PATIENT CHANGED HIS T SHIRT. INFUSION RESUMED WITH NEW FILTER ATTACHED TO IV LINE. NO INJURY REPORTED.
Patient problems: Chemical Exposure
MAUDE report 17719671 ↗MalfunctionSep 11, 2023Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: DETAILS OF COMPLAINT (REPORTED ISSUE): WRITER WAS CIRCLE PRIMING ETOPOSIDE AND ETOPOSIDE STARTED DRIPPING FROM THE TOP OF THE FILTER. WRITER STOPPED CIRCLE PRIME AND CHECKED TO ENSURE THAT THE CONNECTION WAS SECURE, CONNECTION WAS NOT LOOSE. WRITER CHANGED THE FILTER AND CLOSED SYSTEM TRANSFER DEVICE AND REPRIMED NEW FILTER, NO LEAKS NOTED. ALL CONNECTIONS TAPED AND BLUE COVER APPLIED OVER CLOSED SYSTEM TRANSFER DEVICE. PLASTIC BAG TAPED AROUND FILTER TO MONITOR FOR ANY LEAKS. TEAM LEAD MADE AWARE OF SAME. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17719352 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.