Alaris 2202-0500Recalls & reported problems
BD Switzerland Sàrl · Pump Infusion Set, 1.2 Micron Filter 308 cm (121 in) · Class 2
All models of Alaris (85)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613203021357), received between Aug 26, 2020 and Aug 26, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Complete Blockage” (1 report).
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
- Complete Blockage1
- Illegible Information1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 26, 2020Complete Blockage; Illegible Information; Complete Blockage; Illegible Information
IT WAS REPORTED THAT AS LVP 20D DEHP 1.2M HAD FLOW ISSUES BECAUSE THE WRONG FILTER WAS USED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 2202-0500. BATCH(LOT) NO: UNKNOWN. IT WAS REPORTED THAT THE WRONG FILTER WAS OBTAINED AND THE MEDICATION WAS NOT APPROPRIATELY INFUSING THROUGH THE LINE, DUE TO 0.2 MICRON AND 1.2 MICRON FILTERS ARE SIMILARLY PACKAGED. ADDITIONAL INFORMATION (CUSTOMER RESPONSE) (B)(6) 2020: WE ARE THE REPORTING PROGRAM, NOT THE HOSPITAL. PLEASE DESCRIBE THE ERROR OR POTENTIAL ERROR: AMPHOTERICIN B LIPOSOMAL INFUSION REQUIRES A 1.2 MICRON IN-LINE FILTER FOR APPROPRIATE AND SAFE ADMINISTRATION. AT TIME OF ADMINISTRATION, THE NURSE CARING FOR THE PATIENT OBTAINED A 0.2 MICRON IN-LINE FILTER AND BEGAN THE AMPHOTERICIN B LIPOSOMAL INFUSION. UPON FURTHER INVESTIGATION, IT WAS DISCOVERED THAT THE WRONG FILTER WAS OBTAINED AND THE MEDICATION WAS NOT APPROPRIATELY INFUSING THROUGH THE LINE. FURTHERMORE, THE UNIT PHARMACIST AND NURSE IDENTIFIED THAT THE BD ALARIS PUMP INFUSION SET 0.2 MICRON AND BD ALARIS PUMP INFUSION SET 1.2 MICRON FILTER PACKAGING LOOK IDENTICAL, RESULTING IN THE NURSE OBTAINING THE INCORRECT FILTER. ALTHOUGH THIS SCENARI
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10457099 ↗
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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
- 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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