MedSystem III, SmartSite 28493ERecalls & reported problems
BD Switzerland Sàrl · Infusion Set, 2 Check Valves, 3 Needle-Free Valves, Vented/Nonvented, 292 cm (115 in) · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10885403274916), received between Feb 17, 2021 and Aug 5, 2021 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (4 reports).
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 18, 2026.
Most reported problems
Device problems
- Leak/Splash4
- Complete Blockage1
- Free or Unrestricted Flow1
- Material Deformation1
- Restricted Flow rate1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 5, 2021Free or Unrestricted Flow; Material Deformation; Free or Unrestricted Flow; Material Deformation
IT WAS REPORTED THAT MSIII 20D DEHP 3SS 2CV HAD AIR IN LINE AND WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT SOME SETS DO NOT FIT IN THE PUMP. IT WAS REPORTED THAT THERE HAVE BEEN MANY AIR IN LINE ALARMS FOR THESE SETS. VERBATIM: THE ISSUE WITH THE SET SEEMS TO BE HAPPENING ACROSS ALL FOUR BASES AND STARTED A MONTH, IF NOT A LITTLE FURTHER BACK. SOME SETS DON'T FIT INTO THE PUMP. THE CASSETTE SEEMS SLIGHTLY TO LARGE AND NEED TO BE FORCED INTO THE PUMP AND OTHERS WOULD NOT COME OUT REQUIRING THE PUMP TO BE TAKEN APART. TOO MANY AIR IN LINE ALARMS ARE ALSO BEING REPORTED BACK TO THESE SETS. 95% OF THE TIME THEY ARE USABLE BUT THE 5% NEED TO BE THROWN OUT AND REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12283786 ↗MalfunctionAug 5, 2021Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE MSIII W/CV 3VLV PORTS 1 WAY FV EXPERIENCED DEFECTIVE TUBING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ALARIS PUMP HAS BEEN SERVICED BUT STILL GETTING AN ERROR CODE STATING: "THE TUBING COLLAR IS NOT PROPERLY SEATED."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12282293 ↗MalfunctionAug 5, 2021Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE MSIII W/CV 3VLV PORTS 1 WAY FV EXPERIENCED DEFECTIVE TUBING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ALARIS PUMP HAS BEEN SERVICED BUT STILL GETTING AN ERROR CODE STATING: ¿ THE TUBING COLLAR IS NOT PROPERLY SEATED.¿
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12282288 ↗MalfunctionAug 5, 2021Leak/Splash; Leak/Splash
IT WAS REPORTED THAT 2 MSIII W/CV 3VLV PORTS 1 WAY FV EXPERIENCED DEFECTIVE TUBING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ALARIS PUMP HAS BEEN SERVICED BUT STILL GETTING AN ERROR CODE STATING: ¿ THE TUBING COLLAR IS NOT PROPERLY SEATED.¿
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12282284 ↗MalfunctionAug 5, 2021Leak/Splash; Leak/Splash
IT WAS REPORTED THAT 3 MSIII W/CV 3VLV PORTS 1 WAY FV EXPERIENCED DEFECTIVE TUBING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ALARIS PUMP HAS BEEN SERVICED BUT STILL GETTING AN ERROR CODE STATING: ¿ THE TUBING COLLAR IS NOT PROPERLY SEATED.¿
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12282134 ↗MalfunctionFeb 17, 2021Complete Blockage; Restricted Flow rate; Complete Blockage; Restricted Flow rate
IT WAS REPORTED THAT MSIII 20D DEHP 3SS 2CV HAD TUBING ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL#: 28493E, BATCH/LOT#: 20075121. IT WAS REPORTED THAT THERE HAS BEEN AN INCREASE IN CARTRIDGE ALARMS ON THE PUMPS AND CASSETTE JAMS IN WHICH BIOMED FEELS THAT IT MAY BE AN ISSUE WITH THE TUBING.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 11340565 ↗
Other Set, administration, intravascular devices
- Autosoft XC 1001680Unomedical A/S · Set, Administration, Intravascular1 death16,105 reports
- 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
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page