MedSystem III, SmartSite 28117ERecalls & reported problems
BD Switzerland Sàrl · Infusion Half Set, Smallbore Tubing, Needle-Free Valve 216 cm (85 in) · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10885403274893), received between Jun 3, 2019 and Aug 5, 2021 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (3 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/Splash3
- Complete Blockage1
- Fluid/Blood Leak1
- Restricted Flow rate1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 5, 2021Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE MSIII HALF DEHP SS TUBING WAS DEFECTIVE AND NOT PROPERLY SEATED DURING USE. THIS OCCURRED ONCE EACH IN LOTS 20076951 AND AN UNSPECIFIED LOT. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 3 RELATED INCIDENTS. 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 12283405 ↗MalfunctionAug 5, 2021Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE MSIII HALF DEHP SS TUBING WAS DEFECTIVE AND NOT PROPERLY SEATED DURING USE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 3 RELATED INCIDENTS. 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 12283330 ↗MalfunctionAug 5, 2021Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE MSIII HALF DEHP SS TUBING WAS DEFECTIVE AND NOT PROPERLY SEATED DURING USE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 3RD OF 3 RELATED INCIDENTS. 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 12283179 ↗MalfunctionFeb 18, 2021Complete Blockage; Restricted Flow rate; Complete Blockage; Restricted Flow rate
IT WAS REPORTED THAT THE 86" HALF SET W/1 VLV PORT WAS CLOGGED/BLOCKED/OCCLUDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER MATERIAL #: 28117E BATCH/LOT #: 20076813 WE HAVE SEEN A SIGNIFICANT INCREASE IN CARTRIDGE ALARMS ON THE PUMPS. CASSETTE JAMS ETC. BIOMED FEELS THAT IT MAY BE AN ISSUE WITH THE TUBING.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 11341427 ↗MalfunctionJun 3, 2019Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT A LEAK WAS NOTICED AT THE CONNECTION BETWEEN THE EXTENSION SET AND A PORT NEEDLE. THE USER REMOVED THE SET AND ATTACHED A NEW EXTENSION SET FROM THE SAME LOT WITH NO FURTHER LEAK ISSUES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8663015 ↗
Other Set, administration, intravascular devices
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- 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.
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