Infusomat® 362420Recalls & reported problems
B. Braun Medical Inc. · SPACE PUMP SET 15 DROP W/2 SAFEDAY · Class 2
All models of Infusomat (54)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
3 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This B. Braun Space Pump Set is an IV administration line with two Safeday ports, used to pump fluids and chemotherapy. The 29 reports mostly describe air-in-line alarms with no air actually present, and leaking at the vent cap or bottom port during chemo infusions, with no deaths and no injuries. Three recalls are open, covering medication backflow between piggyback and primary containers and tubing that triggers false air alarms; the most recent began in October 2025.
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
- 29
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 3
Summary
The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 04046955592715), received between May 11, 2021 and Feb 4, 2026 — classified as 29 malfunctions.
The most frequently reported specific device problem is “Air/Gas in Device” (14 reports).
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. 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
- 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 · Recall details · 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-2382-2024 · Root cause: Process control · Recall details · 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 · Recall details · FDA record ↗
Most reported problems
Device problems
- Air/Gas in Device14
- Leak/Splash11
- Device Alarm System4
- Improper Flow or Infusion1
Patient problems
- No Clinical Signs, Symptoms or Conditions29
Recent adverse event reports
The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 4, 2026Leak/Splash
AS REPORTED BY THE USER FACILITY: DURING CHEMOTHERAPY SET WAS REPORTED TO BE LEAKING FROM THE VENT CAP. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24259315 ↗MalfunctionJan 30, 2026Leak/Splash
AS REPORTED BY THE USER FACILITY: DURING CHEMOTHERAPY, SET WAS REPORTED TO BE LEAKING FROM THE VENT CAP. NO PATIENT HARM AND NO STAFF HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24222443 ↗MalfunctionJan 29, 2026Leak/Splash
AS REPORTED BY THE USER FACILITY: DURING CHEMOTHERAPY SET WAS REPORTED TO BE LEAKING FROM THE VENT CAP. NO PATIENT HARM AND NO STAFF HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24209876 ↗MalfunctionJan 13, 2026Leak/Splash
AS REPORTED BY THE USER FACILITY: DURING CHEMOTHERAPY SET WAS REPORTED TO BE LEAKING FROM THE VENT CAP. NO PATIENT HARM AND NO STAFF HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24054094 ↗MalfunctionMay 12, 2025Air/Gas in Device; Air/Gas in Device
AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THERE WAS DIFFICULTIES WITH AIR-IN-LINE ALARMS. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22005490 ↗MalfunctionMar 4, 2025Air/Gas in Device; Air/Gas in Device
AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION: AIR IN LINE ALARM WITH NO VISIBLE AIR. DETAILED INQUIRY DESCRIPTION KEPT GETTING AIR IN LINE ALARMS WHEN THERE WAS NO AIR. PUMP WORKED FINE WITH DIFFERENT TUBING. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21516112 ↗MalfunctionJan 22, 2024Device Alarm System; Leak/Splash; Device Alarm System; Leak/Splash
AS REPORTED BY THE USER FACILITY: THE BOTTOM PORT OF A SET OF LINES STARTED LEAKING DURING CHEMO TREATMENT. WITH ANOTHER SET OF LINES, THE TUBING AT THE BOTTOM HALF COMPLETELY FELL OFF. WE ALSO GET A LOT OF FALSE AIR BUBBLE ALARMS AND HAVE ATTEMPTED TO SWITCH OUT PUMPS TO NO AVAIL. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18551694 ↗MalfunctionJan 11, 2024Air/Gas in Device; Air/Gas in Device
AS REPORTED BY THE USER FACILITY: EVENT 3: ACCOUNT HAS REPORTED 'MULTIPLE' OCCURRENCES OF AIR-IN-LINE ALARMS. BRIEF INQUIRY DESCRIPTION: CONTINUOUS AIR IN LINE ALARMS. DETAILED INQUIRY DESCRIPTION: CONTINUOUS AIR IN LINE ALARMS REQUIRING A CHANGE OUT OF THE TUBING TO A NEW PRIMARY SET. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18494779 ↗MalfunctionJan 11, 2024Air/Gas in Device; Air/Gas in Device
AS REPORTED BY THE USER FACILITY: EVENT 1: ACCOUNT HAS REPORTED 'MULTIPLE' OCCURRENCES OF AIR-IN-LINE ALARMS. BRIEF INQUIRY DESCRIPTION: CONTINUOUS AIR IN LINE ALARMS. DETAILED INQUIRY DESCRIPTION: CONTINUOUS AIR IN LINE ALARMS REQUIRING A CHANGE OUT OF THE TUBING TO A NEW PRIMARY SET. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18494777 ↗MalfunctionJan 11, 2024Air/Gas in Device; Air/Gas in Device
AS REPORTED BY THE USER FACILITY: EVENT 2: ACCOUNT HAS REPORTED 'MULTIPLE' OCCURRENCES OF AIR-IN-LINE ALARMS. BRIEF INQUIRY DESCRIPTION: CONTINUOUS AIR IN LINE ALARMS. DETAILED INQUIRY DESCRIPTION: CONTINUOUS AIR IN LINE ALARMS REQUIRING A CHANGE OUT OF THE TUBING TO A NEW PRIMARY SET. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18494776 ↗MalfunctionDec 3, 2023Device Alarm System; Device Alarm System
AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION: INFUSOMAT GIVING AIL ALARMS DURING INFUSION. DETAILED INQUIRY DESCRIPTION: INFUSOMAT GIVING AIL ALARMS DURING INFUSION. NUMEROUS SETS TRIGGERING AIL ALARMS ON PUMPS WHEN NO AIR BUBBLES ARE PRESENT. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18253619 ↗MalfunctionNov 15, 2023Device Alarm System; Device Alarm System
AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION: AIL PRESENTING WHEN NO AIR IS PRESENT. DETAILED INQUIRY DESCRIPTION: SEVERAL PUMPS ARE ALERTING AIL WHEN NO AIR IS PRESENT. ALARMS ARE NOT SPECIFIC TO ONE DRUG OR ONE PUMP. STAFF IS ABLE TO CLEAR SOME ALARMS BUT NOT ALL. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18144935 ↗MalfunctionNov 7, 2023Air/Gas in Device; Air/Gas in Device
AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION: TUBING CAUSING AIR IN LINE ALARMS. DETAILED INQUIRY DESCRIPTION: TUBING CAUSING AIR IN LINE AND UPSTREAM OCCLUSION ALARMS REQUIRE THE NURSES TO SEND THE DRUGS BACK TO PHARMACY TO SWITCH THEM OUT BECAUSE THEY ARE CHEMO REGIMENS. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18085761 ↗MalfunctionSep 25, 2023Device Alarm System; Device Alarm System
AS REPORTED BY THE USER FACILITY: TUBING IN SPACE PUMP READING AIR. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17814922 ↗MalfunctionSep 25, 2023Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION: TUBING CAME OFF OF Y SITE. DETAILED INQUIRY DESCRIPTION: TUBING CAME OFF OF Y SITE HAD TO DISPOSE OF AS CHEMO LEAKED ALL OVER THE FLOOR. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17814918 ↗MalfunctionSep 18, 2023Air/Gas in Device; Air/Gas in Device
AS REPORTED BY THE USER FACILITY: REGISTERED NURSE REPORTED THAT THE CUSTOMER FACILITY IS HAVING AN ONGOING ISSUE WITH THE SPACE PUMP SET 15 DROP W/2 SAFEDAY - SPECIFICALLY WITH THE IVIG IN GLASS BOTTLES. THE INFUSION STARTS OUT FINE ON THE PUMP BUT AS THE MEDICATION IS BEING INFUSED, THE PUMP WILL BEGIN TO HAVE FREQUENT IN AIR IN LINE ALARMS AND THE MEDICAL STAFF IS ABLE TO SEE BUBBLES IN THE TUBING. THE VENT TO THE TUBING IS OPEN - THE USER INQUIRED IF THERE IS ANOTHER PIECE TO USE WHEN SPIKING THE BOTTLE TO PREVENT AIR BUBBLES. IVIG (INTRAVENOUS IMMUNOGLOBULIN) IS KIND OF A STICKY FLUID SO IF ANTIBOIOTICS ARE BIENG GIVEN IT IS NOT THE SAME ISSUE - IT SEEMS TO BE HAPPENING WITH MORE WITH THIS MEDICATION. TO CLARIFY: THE CUSTOMER REPORTED THAT AIR IN LINES AND BUBBLES ARE MORE FREQUENT WHEN THEY ARE ADMINISTERING THE IVIG (INTRAVENOUS IMMUNOGLOBULIN). AS THE MEDICINE IN MORE STICKY IT SEEMS TO BE THE CAUSE OF MORE FREQUENT AIR IN LINE EVENTS. THEY DO NOT SEE THIS AS MUCH WHEN ADMINISTERING ANTIBIOTICS. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17770404 ↗MalfunctionJul 18, 2023Air/Gas in Device; Air/Gas in Device
AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: AIR BUBBLE ALARM WHEN INFUSING KYPROLIS. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17344092 ↗MalfunctionJul 14, 2023Air/Gas in Device; Air/Gas in Device
AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: REPEATING ACCUMULATED AIR ALARM WHILE INFUSING CISPLATIN. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17324969 ↗MalfunctionJul 14, 2023Air/Gas in Device; Air/Gas in Device
AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: REPEATING ACCUMULATED AIR ALARM WHILE INFUSING CISPLATIN. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17324957 ↗MalfunctionJul 14, 2023Air/Gas in Device; Air/Gas in Device
AS REPORTED BY THE USER FACILITY: EVENT 2: DETAILED INQUIRY DESCRIPTION: REPEATED ACCUMULATED AIR ALARM DURING ERBITUX INFUSION- LINE WAS PRIMED, NO AIR IN LINE. AFTER STARTING THERAPY BUBBLES APPEARED IN LINE. ALARM REPEATED. NEW LINE WAS ADDED AND PUMP REPEATED ALARM. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17324751 ↗MalfunctionJul 14, 2023Air/Gas in Device; Air/Gas in Device
AS REPORTED BY THE USER FACILITY: EVENT 1: DETAILED INQUIRY DESCRIPTION: REPEATED ACCUMULATED AIR ALARM DURING ERBITUX INFUSION- LINE WAS PRIMED, NO AIR IN LINE. AFTER STARTING THERAPY BUBBLES APPEARED IN LINE. ALARM REPEATED. NEW LINE WAS ADDED AND PUMP REPEATED ALARM. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17324743 ↗MalfunctionJul 14, 2023Air/Gas in Device; Air/Gas in Device
AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: REPEATED ACCUMULATED AIR ALARM WHEN INFUSING IVIG. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17324618 ↗MalfunctionJul 12, 2023Air/Gas in Device; Air/Gas in Device
AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: AIR BUBBLES ALARM DURING SALINE INFUSION- LINE WAS PRIMED WITH NO AIR IN LINE. ALARMS SOUNDED AND SMALL BUBBLE HAD ACCUMULATED IN LINE. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17307634 ↗MalfunctionJan 3, 2023Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: THE CONNECTION SITE IS COMING APART DURING CHEMO TREATMENT. TWO POSSIBLE LOT NUMBER PROVIDED: LOT NUMBER 0061849999 - EXPIRY DATE 09/26/2025; PRODUCTION DATE 09/26/2022. LOT NUMBER 0061847222 - EXPIRY DATE 08/30/2025; PRODUCTION DATE 08/30/2022.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16087996 ↗MalfunctionAug 31, 2022Leak/Splash; Leak/Splash
AS REPORTED BY THE FACILITY: CHEMO SPILL DUE TO TUBING COMING APART. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15327823 ↗
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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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