IV Administration Set 480239Recalls & reported problems
B. Braun Medical Inc. · PUMP SET, 15DR, 3 CARESITE, 127 IN. · Class 2
All models of IV Administration Set (153)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This B. Braun pump set is used with infusion pumps to deliver IV fluids and medications. All 67 reports describe the cassette portion leaking or splashing, which can interrupt or under-deliver medication and raise the risk of bloodstream infection. No deaths or injuries are reported. One recall, started in August 2021 and since closed, covered this same leakage problem.
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
- 67
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 67 adverse event reports that list this exact device (DI 04046955137015), received between Oct 11, 2021 and Feb 21, 2022 — classified as 67 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (67 reports).
1 FDA recall record name this device's identifier.
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
- Aug 10, 2021Terminated
Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and bloodstream infections.
Z-2555-2021 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Leak/Splash67
Patient problems
- No Clinical Signs, Symptoms or Conditions67
Recent adverse event reports
The 25 most recent of 67 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 21, 2022Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: EVENT 13: IT WAS REPORTED THAT THE CASSETTE LEAKED. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13573394 ↗MalfunctionFeb 21, 2022Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: EVENT 12: IT WAS REPORTED THAT THE CASSETTE LEAKED. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13573393 ↗MalfunctionFeb 21, 2022Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: EVENT 10: IT WAS REPORTED THAT THE CASSETTE LEAKED. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13573392 ↗MalfunctionFeb 21, 2022Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: EVENT 14: IT WAS REPORTED THAT THE CASSETTE LEAKED. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13573391 ↗MalfunctionFeb 21, 2022Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: EVENT 11: IT WAS REPORTED THAT THE CASSETTE LEAKED. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13573390 ↗MalfunctionFeb 21, 2022Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: EVENT 9: IT WAS REPORTED THAT THE CASSETTE LEAKED. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13573389 ↗MalfunctionFeb 21, 2022Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: EVENT 20: IT WAS REPORTED THAT THE CASSETTE LEAKED. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13573388 ↗MalfunctionFeb 21, 2022Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: EVENT 18: IT WAS REPORTED THAT THE CASSETTE LEAKED. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13573387 ↗MalfunctionFeb 21, 2022Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: EVENT 19: IT WAS REPORTED THAT THE CASSETTE LEAKED. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13573386 ↗MalfunctionFeb 21, 2022Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: EVENT 21: IT WAS REPORTED THAT THE CASSETTE LEAKED. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13573385 ↗MalfunctionFeb 21, 2022Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: EVENT 17: IT WAS REPORTED THAT THE CASSETTE LEAKED. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13573384 ↗MalfunctionFeb 21, 2022Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: EVENT 16: IT WAS REPORTED THAT THE CASSETTE LEAKED. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13573383 ↗MalfunctionFeb 21, 2022Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: EVENT 15: IT WAS REPORTED THAT THE CASSETTE LEAKED. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13573382 ↗MalfunctionFeb 21, 2022Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: EVENT 26: IT WAS REPORTED THAT THE CASSETTE LEAKED. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13573381 ↗MalfunctionFeb 21, 2022Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: EVENT 25: IT WAS REPORTED THAT THE CASSETTE LEAKED. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13573380 ↗MalfunctionFeb 21, 2022Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: EVENT 27: IT WAS REPORTED THAT THE CASSETTE LEAKED. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13573379 ↗MalfunctionFeb 21, 2022Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: EVENT 29: IT WAS REPORTED THAT THE CASSETTE LEAKED. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13573378 ↗MalfunctionFeb 21, 2022Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: EVENT 24: IT WAS REPORTED THAT THE CASSETTE LEAKED. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13573377 ↗MalfunctionFeb 21, 2022Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: EVENT 22: IT WAS REPORTED THAT THE CASSETTE LEAKED. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13573376 ↗MalfunctionFeb 21, 2022Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: EVENT 23: IT WAS REPORTED THAT THE CASSETTE LEAKED. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13573375 ↗MalfunctionFeb 21, 2022Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: EVENT 33: IT WAS REPORTED THAT THE CASSETTE LEAKED. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13573374 ↗MalfunctionFeb 21, 2022Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: EVENT 31: IT WAS REPORTED THAT THE CASSETTE LEAKED. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13573373 ↗MalfunctionFeb 21, 2022Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: EVENT 28: IT WAS REPORTED THAT THE CASSETTE LEAKED. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13573372 ↗MalfunctionFeb 21, 2022Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: EVENT 34: IT WAS REPORTED THAT THE CASSETTE LEAKED. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13573371 ↗MalfunctionFeb 21, 2022Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: EVENT 32: IT WAS REPORTED THAT THE CASSETTE LEAKED. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13573370 ↗
Other Set, administration, intravascular devices
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- Autosoft90™ 1002817Unomedical A/S · Set, Administration, Intravascular1 recall11,907 reports
- Minimed™ Quick-set™ MMT-399AUnomedical A/S · Set, Administration, Intravascular9 deaths8,669 reports
- Medtronic Extended MMT-431AUnomedical A/S · Set, Administration, Intravascular3 deaths8,574 reports
- MiniMed™ Mio™ Advance MMT-242AUnomedical A/S · Set, Administration, Intravascular15 deaths8,164 reports
- CADD 21-7302-24Icu Medical, Inc. · Set, administration, intravascular4 recalls1 death4,657 reports
- Autosoft XC 1001681Unomedical A/S · Set, Administration, Intravascular1 death4,216 reports
- Minimed™ Quick-set™ MMT-397AUnomedical A/S · Set, Administration, Intravascular19 deaths4,134 reports
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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