Outlook® 470024Recalls & reported problems
B. Braun Medical Inc. · ET82HP OUTLOOK PUMP EXTENSION SET · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04046964297410), received between Nov 18, 2016 and Nov 18, 2016 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Device Operates Differently Than Expected” (3 reports).
1 FDA recall record name this device's identifier.
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.
Recalls naming this device
- Aug 10, 2021Terminated
Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and bloodstream infections.
Z-2550-2021 · Root cause: Under Investigation by firm · FDA record ↗
Most reported problems
Device problems
- Device Operates Differently Than Expected3
Patient problems
- No Consequences Or Impact To Patient3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 18, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected
AS REPORTED BY THE USER FACILITY: EVENT # 2: REPORTS THE NICU IS EXPERIENCING ERROR ALARMS AND EMPTY BAG ALARMS WITH THEIR CUSTOM OUTLOOK LIPID SYRINGE HALF SET. THE PUMP WILL RUN OK FOR AN HOUR OR TWO AND THEN START ALARMING. THIS CAUSES NICU BABIES TO GET BOLUSES OF LIPIDS BECAUSE THE PUMP HAS TO BE RESTARTED AFTER THE NURSE TROUBLESHOOTS THE CASSETTE ISSUE. THE NURSES ARE CLAMPING THE SET AND OPENING THE DOOR ON THE PUMP TO TROUBLESHOOT, AND THIS IS CAUSING SMALL AMOUNTS OF LIPIDS TO INFUSE INTO PATIENTS. THE NURSES ARE NOT DISCONNECTING THE IV SET FROM THE PATIENT BEFORE OPENING THE DOOR TO THE PUMP. THERE WERE NO PATIENT INJURIES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6112856 ↗MalfunctionNov 18, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected
AS REPORTED BY THE USER FACILITY: EVENT # 3: REPORTS THE NICU IS EXPERIENCING ERROR ALARMS AND EMPTY BAG ALARMS WITH THEIR CUSTOM OUTLOOK LIPID SYRINGE HALF SET. THE PUMP WILL RUN OK FOR AN HOUR OR TWO AND THEN START ALARMING. THIS CAUSES NICU BABIES TO GET BOLUSES OF LIPIDS BECAUSE THE PUMP HAS TO BE RESTARTED AFTER THE NURSE TROUBLESHOOTS THE CASSETTE ISSUE. THE NURSES ARE CLAMPING THE SET AND OPENING THE DOOR ON THE PUMP TO TROUBLESHOOT, AND THIS IS CAUSING SMALL AMOUNTS OF LIPIDS TO INFUSE INTO PATIENTS. THE NURSES ARE NOT DISCONNECTING THE IV SET FROM THE PATIENT BEFORE OPENING THE DOOR TO THE PUMP. THERE WERE NO PATIENT INJURIES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6112850 ↗MalfunctionNov 18, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected
AS REPORTED BY THE USER FACILITY: EVENT # 1: REPORTS THE NICU IS EXPERIENCING ERROR ALARMS AND EMPTY BAG ALARMS WITH THEIR CUSTOM OUTLOOK LIPID SYRINGE HALF SET. THE PUMP WILL RUN OK FOR AN HOUR OR TWO AND THEN START ALARMING. THIS CAUSES NICU BABIES TO GET BOLUSES OF LIPIDS BECAUSE THE PUMP HAS TO BE RESTARTED AFTER THE NURSE TROUBLESHOOTS THE CASSETTE ISSUE. THE NURSES ARE CLAMPING THE SET AND OPENING THE DOOR ON THE PUMP TO TROUBLESHOOT, AND THIS IS CAUSING SMALL AMOUNTS OF LIPIDS TO INFUSE INTO PATIENTS. THE NURSES ARE NOT DISCONNECTING THE IV SET FROM THE PATIENT BEFORE OPENING THE DOOR TO THE PUMP. THERE WERE NO PATIENT INJURIES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6112849 ↗
Other Set, administration, intravascular devices
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- Minimed™ Quick-set™ MMT-399AUnomedical A/S · Set, Administration, Intravascular9 deaths8,669 reports
- Medtronic Extended MMT-431AUnomedical A/S · Set, Administration, Intravascular3 deaths8,574 reports
- MiniMed™ Mio™ Advance MMT-242AUnomedical A/S · Set, Administration, Intravascular15 deaths8,164 reports
- CADD 21-7302-24Icu Medical, Inc. · Set, administration, intravascular4 recalls1 death4,657 reports
- Autosoft XC 1001681Unomedical A/S · Set, Administration, Intravascular1 death4,216 reports
- Minimed™ Quick-set™ MMT-397AUnomedical A/S · Set, Administration, Intravascular19 deaths4,134 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 · each recall links to the FDA recall notice
- 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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