Outlook® 354216Recalls & reported problems
B. Braun Medical Inc. · 10 drops/mL, Priming volume: 46mL, length, 130in · Class 2
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 04046964182273), received between Nov 29, 2016 and Mar 15, 2022 — classified as 10 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (6 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-2548-2021 · Root cause: Under Investigation by firm · FDA record ↗
Most reported problems
Device problems
- Leak/Splash6
- Fluid/Blood Leak3
- Device Operates Differently Than Expected1
Patient problems
- No Clinical Signs, Symptoms or Conditions7
- No Consequences Or Impact To Patient2
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 15, 2022Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION: BLOOD TUBING LEAKED INTO PUMP AFTER TRANSFUSION. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13774659 ↗MalfunctionSep 17, 2021Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT THE BLOOD SET LEAKED BLOOD DURING USE. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12490744 ↗MalfunctionSep 2, 2021Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: THE NURSING UNITS CONFIRMED THAT THEY HAVE EXPERIENCED LEAKING FROM THE CASSETTE. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12419057 ↗MalfunctionSep 2, 2021Leak/Splash; Leak/Splash
AS REPORTED VIA MEDWATCH MW5102935: "BLOOD LEAKED FROM THE TUBING AT THE ROUND AREA OF THE CASSETTE." NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12419053 ↗MalfunctionAug 16, 2021Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT THE RN TOOK DOWN BLOOD TUBING AND WHEN PUMP CHAMBER OPENED, BLOOD WAS NOTED TO HAVE LEAKED FROM TUBING CARTRIDGE IN PUMP. SMALL AMOUNT NOTED. PATIENT COMPLETED BLOOD TRANSFUSION AND FLUSH. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12323882 ↗MalfunctionAug 12, 2021Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT THE SET LEAKED. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12315648 ↗MalfunctionJun 21, 2021Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: END USER REPORTS, "WE CURRENTLY USE REF NUMBER- 354216 THE Y TYPE TUBING. THERE WAS AN ISSUE WITH GIVING BLOOD LAST WEEK WHEN THE TUBING STARTED LEAKING NEAR THE CASSETTE PART OF THE TUBING." NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12037016 ↗MalfunctionMar 11, 2020Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT WHEN THE BLOOD WAS HUNG AND RUNNING ON PATIENT THE END USER REALIZED MIDWAY THROUGH THE INFUSION BLOOD WAS LEAKING OUT OF THE BOTTOM OF THE BLOOD CHAMBER. NO INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9817494 ↗MalfunctionMay 18, 2018Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: CUSTOMER REPORTS THAT UPON COMPLETION OF A BLOOD TRANSFUSION, BLOOD DROPS WERE NOTED ON THE OUTLOOK INFUSION PUMP AND ON THE FLOOR. THE CLINICIAN THEN NOTICED A CRACK IN THE TUBING. THE CRACK WAS LOCATED NEAR THE TOP CLAMP OF THE IV SET. IT WAS STATED THAT THERE WAS NO AFFECT TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7525262 ↗MalfunctionNov 29, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected
AS REPORTED BY USER FACILITY: REPORTS TUBING LEAKING RESULTING IN OUTLOOK PUMP HAVING BLOOD THROUGHOUT THE INTERNAL PUMPING AREA. NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6133504 ↗
Other Set, administration, intravascular devices
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- Autosoft90™ 1002817Unomedical A/S · Set, Administration, Intravascular1 recall11,907 reports
- 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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.