Alaris C70101Recalls & reported problems
BD Switzerland Sàrl · Secondary Set, 15 Micron Filter, Vented/Nonvented 91 cm (36 in) · Class 2
All models of Alaris (85)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885403235733), received between Aug 15, 2019 and Jan 10, 2020 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Component Missing” (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 16, 2026.
Most reported problems
Device problems
- Component Missing1
- Fluid/Blood Leak1
- Insufficient Flow or Under Infusion1
- Obstruction of Flow1
Patient problems
- No Consequences Or Impact To Patient1
- No Patient Involvement1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 10, 2020Fluid/Blood Leak; Component Missing; Fluid/Blood Leak; Component Missing
IT WAS REPORTED THAT A CHEMICAL SPILL OCCURRED DURING SETUP AS THE VENT CAP ASSEMBLY WAS MISSING FROM THE TUBING. WHILE PREPARING NAB-PACLITAXEL WHICH IS CYTOTOXIC (A CHEMOTHERAPY MEDICATION). AS PER INSTRUCTIONS FROM (B)(6), THE PHARMACIST PRIMED THE TUBING WITH NORMAL SALINE, ATTACH THE TUBING TO AN EMPTY VIAFLEX BAG, THEN ADDED THE NABPACLITAXEL TO THE BAG. WHEN THE LINE WAS PRIMED THE BAG WAS HANGING SO THEY DIDN¿T NOTICE THE VENT CAP WAS MISSING. IT WASN¿T UNTIL THE NABPACLITAXEL WAS ADDED THAT FLUID STARTED LEAKING FROM THE TUBING. THIS HAPPENED IN THE BIOLOGICAL SAFETY CABINET. THIS WAS TREATED AS A CHEMICAL SPILL AND CLEANED IT UP WITH NO ISSUE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 9577783 ↗MalfunctionAug 15, 2019Insufficient Flow or Under Infusion; Obstruction of Flow; Insufficient Flow or Under Infusion; Obstruction of Flow
IT WAS REPORTED THAT WHILE ADMINISTERING ALBUM VIA A SECONDARY SET TO A PATIENT, THE TUBING WOULD NOT FLOW (PRIME). WHEN THE NURSE FINALLY GOT THE TUBING TO PRIME, IT STILL WOULD NOT DRIP FROM THE LINE ON THE PUMP OR FREE FLOW WITH THE CLAMP OPEN. THE NURSE FINALLY CLAMPED THE PRIMARY TUBING TO INITIATE FLOW FROM THE SECONDARY TUBING. A HALF HOUR INFUSION TURNED INTO AN HOUR AND A HALF. THERE WAS NO HARM TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8899351 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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