Outlook® 490580Recalls & reported problems
B. Braun Medical Inc. · OUTLOOK PUMP SET, 15 DR, 134 IN. · Class 2
- 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 04046955287598), received between Aug 21, 2019 and Aug 21, 2019 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (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
- Fluid/Blood Leak1
- Improper Flow or Infusion1
Patient problems
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 21, 2019Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT THE TUBING BROKE AT THE ANTI-REFLUX VALVE. IT PRIMED AND BROKE WHEN THE INFUSION WAS STARTED. BLOOD BACKED UP AND CONTAMINATED THE BED AND THE PATIENT. NO INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8917070 ↗MalfunctionAug 21, 2019Improper Flow or Infusion; Improper Flow or Infusion
AS REPORTED BY THE USER FACILITY: CUSTOMER STATED THAT EVEN IF THE ROLLER CLAMP IS CLOSED, THE SET CONTINUES TO DRIP. NO INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8917069 ↗
Other Stopcock, i.V. Set devices
- Connecta, Luer-Lok 394910BD Switzerland Sàrl · Stopcock, i.V. Set3 recalls8 reports
- Outlook® 490361B. Braun Medical Inc. · Stopcock, i.V. Set3 recalls0 reports
- Blood Administration Set 490530B. Braun Medical Inc. · Stopcock, i.V. Set2 recalls11 reports
- Medex MX9341LIcu Medical, Inc. · Stopcock, i.V. Set63 reports
- ICU Medical AC135Icu Medical, Inc. · Stopcock, i.V. Set1 recall10 reports
- IV Administration Set 490067B. Braun Medical Inc. · Stopcock, i.V. Set1 recall9 reports
- ICU Medical MC330174Icu Medical, Inc. · Stopcock, i.V. Set1 recall4 reports
- ICU Medical Z2587Icu Medical, Inc. · Stopcock, i.V. Set1 recall3 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.