Infusomat® 363904Recalls & reported problems

Summary

The FDA's MAUDE database contains 116 adverse event reports that list this exact device (DI 04046964699061), received between Nov 18, 2019 and Apr 10, 2026 — classified as 116 malfunctions.

The most frequently reported specific device problem is “Air/Gas in Device” (67 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.

Recalls naming this device

1. 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

Recent adverse event reports

The 25 most recent of 116 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 10, 2026Device Alarm System

  AS REPORTED BY THE USER FACILITY: AIR IN LINE; UNABLE TO RESOLVE DESPITE THOROUGH TROUBLESHOOTING. NO VISIBLE AIR IN SET. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24838762 ↗
• MalfunctionOct 24, 2025Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: DETAILS OF COMPLAINT (REPORTED ISSUE): "A NURSE IN THE SURGICAL MEDICAL INTENSIVE CARE UNIT REPORTED THAT DESPITE CHECKING THE CONNECTIONS AND TUBING AT THE BEGINNING OF HER SHIFT, THE "ANTI-SIPHON" VALVE AUTOMATICALLY LOOSENED FROM THE TUBING 4 HOURS LATER, CAUSING A VASOPRESSOR THAT WAS SCHEDULED TO BE RELEASED AT A HIGH DOSE. FORTUNATELY, THERE WAS NO SEVERE IMPACT ON THE PATIENT." 1. THE REPORT MENTIONS "A VASOPRESSOR THAT WAS SCHEDULED TO BE RELEASED AT A HIGH DOSE." COULD YOU CONFIRM WHICH OF THE FOLLOWING OCCURRED: EXTERNAL LEAKAGE FROM THE INFUSION SET. THE NURSE HAD DONE HER INITIAL CHECK AT THE START OF THE SHIFT, AND CONFIRMED THAT ALL CONNECTIONS, LINES AND TUBING'S WERE PROPERLY SECURED. ABOUT 4H INTO HER SHIFT, SHE NOTICED A LEAK AT THE CONNECTION SITE OF THE ANTI-SIPHON VALVE. IT APPEARED THAT THE VALVE HAD BECOME LOOSE SOMEHOW FROM THE ADJACENT TUBING, WHICH RESULTED IN THE LEAK. THE INFUSION HAD BEEN RUNNING CONTINUOUSLY THE ENTIRE TIME, ALTHOUGH TITRATION OF THE MEDICATION WAS PERFORMED AS REQUIRED. HOWEVER, THE INFUSION WAS NEVER PAUSED OR RESTARTED AT A HIGHER RATE, SO IT IS UNLIKELY THAT THE CAUSE OF THE LEAK WAS A PRESSURE SUR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23385020 ↗
• MalfunctionMar 13, 2025Air/Gas in Device; Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: INCIDENT DESCRIPTION: AMIODARONE INFUSION. BUBBLES ALARM- FREQUENT, IV TUBING LESS THAN 24 HOURS USE. PATIENT ON AMIODARONE INFUSION FOR 3 DAYS AND HAVE HAD TO CHANGE THE TUBING EVERY DAY DUE TO BUBBLE ALARM THAT CAN BE FIXED BY FLICKING THE BUBBLES OR REPRIMING THE TUBE AGAIN. FLUID ROOM TEMP DRIP CHAMBER 1/2-2/3 FILLED TUBING PROPERLY LOADED IV LINE PRIMED THROUGH PUMP UNUSED PRIME FUNCTION TO REMOVE AIR IN LINE ALARM RECURRED, REPRIME OPEN DOOR REMOVE AND VISUALIZE TUBING TAP TUBING SECTION AND OBSERVE FOR BUBBLES VISIBLE BUBBLES, USED ALCOHOL PAD AND WIPED SEGMENT OF TUBING BETWEEN THE SILICONE PUMP SEGMENT AND GREEN CLAMP, RELOAD TUBING AND RESTART. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21599039 ↗
• MalfunctionMar 12, 2025Air/Gas in Device; Air/Gas in Device

  ADDITIONAL INFORMATION PROVIDED: ACCORDING TO THE COMPLAINANT, A 6-HOUR PROTAMINE INFUSION WAS BEING ADMINISTERED. THE FLUID WAS AT ROOM TEMPERATURE, WITH THE DRIP CHAMBER ½ TO 2/3 FILLED, AND THE TUBING PROPERLY LOADED. THE INTRAVENOUS (IV) LINE WAS PRIMED THROUGH THE PUMP, WITH THE PRIME FUNCTION BEING USED TO REMOVE AIR FROM THE LINE. DURING THE INFUSION, AN AIR IN LINE ALARM WAS TRIGGERED, PROMPTING THE FOLLOWING TROUBLESHOOTING STEPS. THE USER REPRIMED THE LINE, OPENED THE PUMP DOOR, REMOVED AND VISUALIZED THE TUBING, AND THEN TAPPED THE SECTION IN QUESTION TO CHECK FOR AIR BUBBLES. AIR BUBBLES WERE VISIBLE. THE USER THEN WIPED THE TUBING SEGMENT WITH AN ALCOHOL PAD, SPECIFICALLY IN THE AREA BETWEEN THE SILICONE PUMP SEGMENT AND THE GREEN CLAMP, BEFORE RELOADING THE TUBING AND RESTARTING THE PUMP. THE ALARM RECURRED, PROMPTING REPLACEMENT OF THE IV SET. ONE HOUR BEFORE COMPLETING THE TOTAL 6-HOUR DOSE, AN AIR BUBBLE ALARM WAS TRIGGERED AGAIN. THE USER ATTEMPTED TO FLICK THE BUBBLES, BUT THIS METHOD WAS INEFFECTIVE. ADDITIONALLY, THE USER FELT THAT FLUSHING THE LINE WAS NOT AS OPTION, AS IT WOULD RESULT IN LOST MEDICATION, PREVENTING THE PATIENT FROM RECEIVING THE FULL DOSE. TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21588493 ↗
• MalfunctionMar 5, 2025Air/Gas in Device; Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: DETAILS OF COMPLAINT (REPORTED ISSUE): SODIUM PHOSPHATE BUBBLES ALARM MULTIPLE TIMES EVEN AFTER BUBBLES REMOVED. SODIUM PHOSPHATE BAG HAS BEEN ON ROOM TEMP PRIOR TO HOOKING. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21526409 ↗
• MalfunctionMar 5, 2025Air/Gas in Device; Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: DETAILS OF COMPLAINT (REPORTED ISSUE): VASOPRESSIN DRIP BUBBLES ALARM. TUBING IS LESS THAN 8 IN USE AND HAVE TO CHANGE TUBING.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 21526407 ↗
• MalfunctionMar 5, 2025Air/Gas in Device; Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: DETAILS OF COMPLAINT (REPORTED ISSUE): NOTED EXCESS BUBBLES. WASTED MEDS FROM REMOVING BUBBLES AND FLUSHING. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21526102 ↗
• MalfunctionMar 4, 2025Air/Gas in Device; Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: DETAILS OF COMPLAINT (REPORTED ISSUE): CHASER LINE LR. NEW IV STARTED ON (B)(6) AT 21:50. EXCESS BUBBLE ALARM EVEN ALL THROUGH BUBBLES. LINE CHANGED AT 09:45 (B)(6) ONLY 24 HOURS IN USE. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21516076 ↗
• MalfunctionMar 4, 2025Air/Gas in Device; Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: DETAILS OF COMPLAINT (REPORTED ISSUE): TUBE IN USE LESS THAN 80 NEED TO CHANGE TUBINGS D/T BUBBLES ALARM. TUBING FLICKED FOR BUBBLES MULTIPLE TIMES INTERFERING MED INFUSION (NOREPI, VARO, INSULIN, PROPOFUL. NO INJURY REPORTED).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21516027 ↗
• MalfunctionJan 31, 2025Air/Gas in Device; Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: EVENT 3: DETAILS OF COMPLAINT (REPORTED ISSUE): "AIR IN LINE" ALARM. AMIODARONE INFUSION. BUBBLES ALARM FREQUENT. IV TUBING LESS THAN 24 USE. PT ON AMINO INFUS X 3 DAYS AND WE HAVE BEEN CHANGING TUBING'S EVERYDAY BUBBLE ALARM THAT CAN BE FIXED BY FLICKING THE BUBBLES ON REPRIMING THE TUBE AGAIN." NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21286993 ↗
• MalfunctionJan 31, 2025Air/Gas in Device; Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: EVENT 2: DETAILS OF COMPLAINT (REPORTED ISSUE): "AIR IN LINE" ALARM. AMIODARONE INFUSION. BUBBLES ALARM FREQUENT. IV TUBING LESS THAN 24 USE. PT ON AMINO INFUS X 3 DAYS AND WE HAVE BEEN CHANGING TUBING'S EVERYDAY BUBBLE ALARM THAT CAN BE FIXED BY FLICKING THE BUBBLES ON REPRIMING THE TUBE AGAIN." NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21286992 ↗
• MalfunctionJan 31, 2025Air/Gas in Device; Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: EVENT 1: DETAILS OF COMPLAINT (REPORTED ISSUE): "AIR IN LINE" ALARM. AMIODARONE INFUSION. BUBBLES ALARM FREQUENT. IV TUBING LESS THAN 24 USE. PT ON AMINO INFUS X 3 DAYS AND WE HAVE BEEN CHANGING TUBING'S EVERYDAY BUBBLE ALARM THAT CAN BE FIXED BY FLICKING THE BUBBLES ON REPRIMING THE TUBE AGAIN." NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21286991 ↗
• MalfunctionJan 23, 2025Air/Gas in Device; Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: EVENT 2: DETAILS OF COMPLAINT (REPORTED ISSUE): PT IN ISOLATION FOR COVID +, MULTIPLE ALARMS FOR AIR IN LINE 0 RESOLVED WITH FLUSH MULTIPLE TIMES PUMP AND PULLING OUT + FLUSHING. ENTIRE BAG OF MED WAS FLUSHED WITHIN 5 HOURS AND WASTED + USED 2 IV LINES TRYING TO RESOLVE ALARMS. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21216596 ↗
• MalfunctionJan 23, 2025Air/Gas in Device; Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: EVENT 1: DETAILS OF COMPLAINT (REPORTED ISSUE): PT IN ISOLATION FOR COVID +, MULTIPLE ALARMS FOR AIR IN LINE 0 RESOLVED WITH FLUSH MULTIPLE TIMES PUMP AND PULLING OUT + FLUSHING. ENTIRE BAG OF MED WAS FLUSHED WITHIN 5 HOURS AND WASTED + USED 2 IV LINES TRYING TO RESOLVE ALARMS. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21216595 ↗
• MalfunctionJan 23, 2025Air/Gas in Device; Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: DETAILS OF COMPLAINT (REPORTED ISSUE): "AIR IN LINE" ALARM. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21216544 ↗
• MalfunctionJan 22, 2025Air/Gas in Device; Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: INCIDENT_DESCRIPTION: CONTINUOUS AIR IN LINE DRIP CHAMBER 1/2-2/3 FILLED TUBING PROPERLY LOADED IV LINE PRIMED THROUGH PUMP USED PRIME FUNCTION TO REMOVE AIR IN LINE ALARM RECURRED, RE-PRIME OPENED DOOR, REMOVE AND VISUALIZE TUBING TAP TUBING SECTION AND OBSERVE FOR BUBBLES VISIBLE BUBBLES, USED ALCOHOL PAD AND WIPED SEGMENT OF TUBING BETWEEN THE SILICONE PUMP SEGMENT AND GREEN CLAMP, RELOAD TUBING AND RESTART ALARM RECURRED, CHANGED TUBING UPSTREAM AND DOWNSTREAM OCCLUSIONS, NO ISSUES WITH PATIENTS LINE IV SITE, TUBING CLAMPS OPEN, NO KINKS PRESSURE ADJUSTED AND INFUSION RESTARTED, ALARM RECURRED CHANGED THE TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21206602 ↗
• MalfunctionJan 21, 2025Air/Gas in Device; Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: DETAILS OF COMPLAINT (REPORTED ISSUE): "AIR IN LINE" ALARM. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21196955 ↗
• MalfunctionJan 21, 2025Air/Gas in Device; Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: DETAILS OF COMPLAINT (REPORTED ISSUE): "AIR IN LINE" ALARM. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21196953 ↗
• MalfunctionJan 21, 2025Air/Gas in Device; Air/Gas in Device

  ADDITIONAL INFORMATION PROVIDED: ACCORDING TO THE COMPLAINANT, A 6-HOUR PROTAMINE INFUSION WAS BEING ADMINISTERED. THE FLUID WAS AT ROOM TEMPERATURE, WITH THE DRIP CHAMBER ½ TO 2/3 FILLED, AND THE TUBING PROPERLY LOADED. THE INTRAVENOUS (IV) LINE WAS PRIMED THROUGH THE PUMP, WITH THE PRIME FUNCTION BEING USED TO REMOVE AIR FROM THE LINE. DURING THE INFUSION, AN AIR IN LINE ALARM WAS TRIGGERED, PROMPTING THE FOLLOWING TROUBLESHOOTING STEPS. THE USER REPRIMED THE LINE, OPENED THE PUMP DOOR, REMOVED AND VISUALIZED THE TUBING, AND THEN TAPPED THE SECTION IN QUESTION TO CHECK FOR AIR BUBBLES. AIR BUBBLES WERE VISIBLE. THE USER THEN WIPED THE TUBING SEGMENT WITH AN ALCOHOL PAD, SPECIFICALLY IN THE AREA BETWEEN THE SILICONE PUMP SEGMENT AND THE GREEN CLAMP, BEFORE RELOADING THE TUBING AND RESTARTING THE PUMP. THE ALARM RECURRED, PROMPTING REPLACEMENT OF THE IV SET. ONE HOUR BEFORE COMPLETING THE TOTAL 6-HOUR DOSE, AN AIR BUBBLE ALARM WAS TRIGGERED AGAIN. THE USER ATTEMPTED TO FLICK THE BUBBLES, BUT THIS METHOD WAS INEFFECTIVE. ADDITIONALLY, THE USER FELT THAT FLUSHING THE LINE WAS NOT AS OPTION, AS IT WOULD RESULT IN LOST MEDICATION, PREVENTING THE PATIENT FROM RECEIVING THE FULL DOSE. TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21196952 ↗
• MalfunctionJan 7, 2025Device Alarm System; Air/Gas in Device; Device Alarm System; Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: MEDICATION NEEDED URGENTLY FROM FRIDGE SO WAS NOT AT ROOM TEMPERATURE. AIR IN LINE ALARM. TROUBLESHOOTING COMPLETED. TUBING LOADED PROPERLY, LINE PRIMED, DOOR OPENED, NO VISIBLE AIR BUBBLES. ONGOING ISSUES WITH COLD MEDS FROM FRIDGE. NO SAMPLE AVAILABLE. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21094034 ↗
• MalfunctionDec 11, 2024Air/Gas in Device; Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: INCIDENT DESCRIPTION: AIR INLINE UNABLE TO RESOLVE AFTER PRIMING 3 TIMES AND MANUAL PRIME. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20904599 ↗
• MalfunctionDec 11, 2024Air/Gas in Device; Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: INCIDENT DESCRIPTION: DRIP CHAMBER 1/2-2/3 FILLED TUBING PROPERLY LOADED IV LINE PRIMED THROUGH PUMP UNSED PRIME FUNCTION TO REMOVE AIR IN LINE ALARM RECURRED, REPRIME OPEN DOOR REMOVE AND VISUALIZE TUBING TAP TUBING SECTION AND OBSERVE FOR BUBBLES VISIBLE BUBBLES, USED ALCOHOL PAD AND WIPED SEGMENT OF TUBING BETWEEN THE SILICONE PUMP SEGMENT AND GREEN CLAMP, RELOAD TUBING AND RESTART ALARM RECURRED, CHANGED TUBING COULD NO CLEAR BUBBLES, PRIMED X2 STILL BUBBLE AND AIR BUBBLE ALARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20904541 ↗
• MalfunctionNov 20, 2024Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED TO B. BRAUN MEDICAL INC. THAT AN INFUSOMAT SPACE PUMP INTRAVENOUS (IV) PUMP SET (MATERIAL 363904, LOT UNKNOWN) WAS BEING USED TO ADMINISTER AMIODARONE AT 44 MILLILITERS (ML) PER HOUR ON (B)(6) 2024. ACCORDING TO THE COMPLAINANT, THERE WAS AIR WITHIN THE IV LINE. THE COMPLAINT DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. FROM CHECKLIST, AIR IN LINE. USED PRIME FUNCTION TO REMOVE THE AIR IN THE LINE AND INFUSION RESTARTED. ALARM REOCCURS, USED PRIME FUNCTION AGAIN TO REMOVE THE AIR IN THE LINE AND RESTART INFUSION. OPEN DOOR, REMOVE AND VISUALIZE, TAB THE TUBING SECTION AND OBSERVE FOR BUBBLES. NO VISIBLE BUBBLES, RELOAD THE TUBING AND RESTART INFUSION. ALARM RE-OCCURS. CHANGED THE TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20734607 ↗
• MalfunctionNov 20, 2024Device Alarm System; Device Alarm System

  IT WAS REPORTED TO B. BRAUN MEDICAL INC. THAT AN INFUSOMAT SPACE PUMP INTRAVENOUS (IV) PUMP SET (MATERIAL 363904, LOT 0061939231) WAS BEING USED TO ADMINISTER MILRINONE ON (B)(6) 2024. ACCORDING TO THE COMPLAINANT, THE PUMP ALARMED FOR AIR IN LINE, HOWEVER, THERE WERE NO VISIBLE BUBBLES IN THE IV LINE. THE COMPLAINT DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. FROM CHECKLIST: AIR IN LINE. USED PRIME FUNCTION TO REMOVE THE AIR IN THE LINE AND INFUSION RESTARTED. ALARM REOCCURS, USED PRIME FUNCTION AGAIN TO REMOVE THE AIR IN THE LINE AND RESTART INFUSION. OPEN DOOR, REMOVE AND VISUALIZE TUBING, TAP THE TUBING SECTION AND OBSERVE FOR BUBBLES. NO VISIBLE BUBBLES, RELOAD THE TUBING AND RESTART INFUSION. ALARM RE-OCCURS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20734490 ↗
• MalfunctionNov 18, 2024Device Alarm System; Device Alarm System

  IT WAS REPORTED TO B. BRAUN MEDICAL INC. THAT AN INFUSOMAT SPACE INTRAVENOUS (IV) PUMP SET (MATERIAL 363904, LOT UNKNOWN) WAS BEING USED TO ADMINISTER 4 GRAMS (G) MAGNESIUM AT A RATE OF APPROXIMATELY 50 MILLILITERS PER HOUR (ML/HR) ON (B)(6) 2024. ACCORDING TO THE COMPLAINANT, THE PUMP INITIALLY ALARMED FOR AN UPSTREAM OCCLUSION. THE PRIME FUNCTION WAS USED TO REMOVE AIR FROM THE LINE AND THE INFUSION WAS RESTARTED. HOWEVER, AN AIR IN LINE ALARM OCCURRED. THE PRIME FUNCTION WAS USED ONCE AGAIN TO SUCCESSFULLY PRIME THE LINE, BUT THE AIR-IN-LINE ALARM CONTINUED TO OCCUR. AT THIS TIME, THE DOOR WAS OPENED, THE TUBING WAS REMOVED, INSPECTED, AND TAPPED, TO OBSERVE AND CONFIRM THAT NO AIR WAS PRESENT IN THE LINES. THE TUBING WAS RELOADED, AND THE INFUSION WAS RESTARTED, BUT THE ALARM REOCCURRED PROMPTING THE USE OF A NEW PUMP SET. REPORTEDLY, THE CHEMOTHERAPY HAD TO EVENTUALLY BE RUN VIA GRAVITY. THE COMPLAINT DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20705579 ↗