Alaris 2203-0500Recalls & reported problems
BD Switzerland Sàrl · Pump Infusion Set, 15 Micron Filter, Amber Tubing 278 cm (110 in) · Class 2
All models of Alaris (85)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613203019200), received between Jul 22, 2020 and Jun 1, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (2 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.
Reports received per month
Recalls naming this device
- Aug 19, 2026Class IOpen, Classified
Due to discrepancies in specific attributes in the performance data for infusion sets, which may lead to inappropriate pump performance.
Z-3080-2026 · Root cause: Device Design · Recall details · FDA record ↗
Most reported problems
Device problems
- Leak/Splash2
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 1, 2026Leak/Splash
IT WAS REPORTED THAT THE BD ALARIS PUMP MODULE INFUSION SET HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I WAS ABLE TO TRACE THE SAMPLE PRODUCT I GOT BACK TO AN SLR, AND WE HAD AN OCCURRENCE OF THIS PRODUCT LEAKING. THIS WAS FOR PRODUCT #2203-0500 (NO DOCUMENTED LOT# OR PACKAGING SAVED). DESCRIPTION OF ISSUE BELOW, NO NOTED PATIENT HARM. "TPN TUBING WAS "LEAKING." SHE NOTICED A WETNESS ON THE FLOOR AND ON THE TUBING, SHE ALSO NOTED THAT THERE WASN'T A FILTER."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25350468 ↗MalfunctionJul 22, 2020Leak/Splash; Leak/Splash
IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF ALARIS PUMP MODULE AMBER INFUSION SETS EXPERIENCED COMPONENT SEPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER STATED THE PRODUCT ¿BROKE INTO 2 PIECES WHILE FLUID WAS RUNNING THROUGH IT¿. DOE IS (B)(6) 2020, AND WAS STATED THE INCIDENT HAPPENED DURING USE. CUSTOMER HAD NO FURTHER INFORMATION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10311940 ↗
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- 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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