ambIT 220140Recalls & reported problems
Summit Medical Products, Inc. · Cassette - Filter, Spike · Class 2
Data updated Oct 13, 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 00857595005046), received between Aug 15, 2019 and Oct 15, 2020 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Contamination /Decontamination Problem” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Contamination /Decontamination Problem1
- Device Contamination with Chemical or Other Material1
- Excess Flow or Over-Infusion1
Patient problems
- No Consequences Or Impact To Patient2
- 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.
MalfunctionOct 15, 2020Excess Flow or Over-Infusion; Excess Flow or Over-Infusion
IT WAS REPORTED THAT A PUMP CONNECTED TO A PATIENT FOR CHEMOTHERAPY PURPOSES FLOWED TOO FAST. THE MEDICATION IN THE PUMP WAS TRABECTEDIN. PER ADDITIONAL INFORMATION RECEIVED 29 SEP 2020, THERE WAS NO INJURY TO THE PATIENT AFTER THE FAST FLOW INCIDENT. THE MEDICATION SHOULD HAVE INFUSED OVER 16 HOURS, BUT INSTEAD THE BAG WAS EMPTY AT AROUND 6 HOURS. PER ADDITIONAL INFORMATION RECEIVED 2 OCT 2020, THE CUSTOMER BELIEVES IT IS A FAULTY CASSETTE, NOT THE PUMP, WHICH CAUSED THE FAST FLOW. THE CUSTOMER SWITCHED TO A DIFFERENT LOT OF CASSETTES AND NO FURTHER INCIDENTS HAVE OCCURRED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10683309 ↗MalfunctionAug 15, 2019Contamination /Decontamination Problem; Device Contamination with Chemical or Other Material; Contamination /Decontamination Problem; Device Contamination with Chemical or Other Material
THE DISTRIBUTOR STATED WHILE PREPPING THE CASSETTE TUBING LINE, FOREIGN MATERIAL WAS NOTICED IN THE DOWNSTREAM AREA, BY THE LUER. THIS WAS NOTICED PRIOR TO BEING USED ON A PATIENT. ALSO, ANOTHER CASSETTE STILL IN A SEALED POUCH APPEARED TO HAVE THE SAME FOREIGN MATERIAL IN THE TUBE-SET.
Patient problems: No Consequences Or Impact To Patient; No Patient Involvement
MAUDE report 8896556 ↗
Other Pump, Infusion devices
- Alaris 8100Carefusion 303, Inc. · Pump, infusion2 recalls2 deaths650,218 reports
- Alaris 8100Carefusion 303, Inc. · Pump, infusion4 recalls78 deaths344,514 reports
- Alaris 8015Carefusion 303, Inc. · Pump, infusion2 recalls45 deaths148,093 reports
- BD® Alaris™ Pump Module, Model 8100Carefusion 303, Inc. · Pump, infusion5 recalls30 deaths51,256 reports
- Alaris 8110Carefusion 303, Inc. · Pump, infusion2 recalls4 deaths21,956 reports
- Alaris 8110Carefusion 303, Inc. · Pump, infusion2 recalls2 deaths15,547 reports
- Alaris 8015Carefusion 303, Inc. · Pump, infusion3 recalls6 deaths13,022 reports
- CADD 21-6500-51Icu Medical, Inc. · Pump, infusion2 deaths8,231 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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