Outlook® 621-100ESRecalls & reported problems
B. Braun Medical Inc. · Large Volume Infusion Pump System · Class 2
All models of Outlook (25)
Data updated Oct 16, 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 04046964186516), received between Apr 20, 2018 and Apr 20, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Thermal Decomposition of Device” (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
- Thermal Decomposition of Device1
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.
MalfunctionApr 20, 2018Thermal Decomposition of Device; Thermal Decomposition of Device
AS REPORTED BY THE USER FACILITY: WHILE INFUSING, THE PUMP WAS FOUND TO HAVE SMOKE COMING FROM THE PUMP ITSELF AND IT WAS HOT TO THE TOUCH. THE INFUSION WAS STOPPED. IT WAS INDICATED THERE WAS A SMALL AMOUNT OF SMOKE OBSERVED AT THE BACK OF THE PUMP WITH A BURNT ELECTRICAL ODOR. VANCOMYCIN 1 GRAM RECONSTITUTED IN 250ML OF 0.9% SODIUM CHLORIDE WAS INFUSING AT THE TIME. THE VOLUME TO BE INFUSED WAS 250ML AT A RATE OF 167ML/HR. THERE WAS NO INJURY TO THE PATIENT
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7447683 ↗
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 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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