Safsite® 473063Recalls & reported problems
B. Braun Medical Inc. · MFE2007S FLTR MICRO VOL 7-IN · Class 2
All models of Safsite (7)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04022495770271), received between Jan 4, 2017 and Jan 4, 2017 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Increased Sensitivity” (7 reports).
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
- Increased Sensitivity7
Patient problems
- No Consequences Or Impact To Patient7
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 4, 2017Increased Sensitivity; Increased Sensitivity
AS REPORTED BY USER FACILITY: EVENT 4: HAVING ISSUE WITH PUMP HIGH PRESSURE ALARMS WITH THE FILTER, CAUSING THE NEED FOR CENTRAL LINE REPLACEMENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6222908 ↗MalfunctionJan 4, 2017Increased Sensitivity; Increased Sensitivity
AS REPORTED BY USER FACILITY: EVENT 7: HAVING ISSUE WITH PUMP HIGH PRESSURE ALARMS WITH THE FILTER, CAUSING THE NEED FOR CENTRAL LINE REPLACEMENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6222880 ↗MalfunctionJan 4, 2017Increased Sensitivity; Increased Sensitivity
AS REPORTED BY USER FACILITY: EVENT 6: HAVING ISSUE WITH PUMP HIGH PRESSURE ALARMS WITH THE FILTER, CAUSING THE NEED FOR CENTRAL LINE REPLACEMENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6222877 ↗MalfunctionJan 4, 2017Increased Sensitivity; Increased Sensitivity
AS REPORTED BY USER FACILITY: EVENT 5: HAVING ISSUE WITH PUMP HIGH PRESSURE ALARMS WITH THE FILTER, CAUSING THE NEED FOR CENTRAL LINE REPLACEMENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6222874 ↗MalfunctionJan 4, 2017Increased Sensitivity; Increased Sensitivity
AS REPORTED BY USER FACILITY: EVENT 3: HAVING ISSUE WITH PUMP HIGH PRESSURE ALARMS WITH THE FILTER, CAUSING THE NEED FOR CENTRAL LINE REPLACEMENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6222855 ↗MalfunctionJan 4, 2017Increased Sensitivity; Increased Sensitivity
AS REPORTED BY USER FACILITY: EVENT 2: HAVING ISSUE WITH PUMP HIGH PRESSURE ALARMS WITH THE FILTER, CAUSING THE NEED FOR CENTRAL LINE REPLACEMENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6222841 ↗MalfunctionJan 4, 2017Increased Sensitivity; Increased Sensitivity
AS REPORTED BY USER FACILITY: EVENT 1: HAVING ISSUE WITH PUMP HIGH PRESSURE ALARMS WITH THE FILTER, CAUSING THE NEED FOR CENTRAL LINE REPLACEMENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6222837 ↗
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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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