Outlook® 354213Recalls & reported problems
B. Braun Medical Inc. · Outlook® Pump Set with 3 CARESITE® Needle-Free Injection Sites · Class 2
2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This B. Braun Outlook pump set is tubing used to deliver fluids and medicines through an IV pump. The 47 reports describe leaking and tubing breaking apart at connections, with no deaths and no injuries mentioned. There are 3 recalls that name this device, including 2 open recalls about medicine flowing back into the wrong IV bag and trouble priming the set, and a closed recall about leaking in the cassette part.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 47
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 3
Summary
The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 04046964182211), received between Oct 3, 2017 and Mar 18, 2024 — classified as 47 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (30 reports).
3 FDA recall records name this device's identifier, 2 still open.
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.
Reports received per month
Recalls naming this device
- Oct 29, 2025Open, Classified
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Z-0707-2026 · Root cause: Process control · FDA record ↗
- Jun 17, 2024Open, Classified
Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of adverse drug reaction and/or product malfunction with loss of medication/blood.
Z-2377-2024 · Root cause: Process control · FDA record ↗
- 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-2545-2021 · Root cause: Under Investigation by firm · FDA record ↗
Most reported problems
Device problems
- Leak/Splash30
- Fluid/Blood Leak15
- Contamination /Decontamination Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions33
- No Consequences Or Impact To Patient6
- No Known Impact Or Consequence To Patient4
- Chemical Exposure3
- Blood Loss1
Recent adverse event reports
The 25 most recent of 47 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 18, 2024Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION: OUTLOOK TUBING LEAKING. DETAILED INQUIRY DESCRIPTION: OUTLOOK TUBING LEAKING BY MAGNET. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18921913 ↗MalfunctionJun 15, 2022Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY. EVENT 1: FLUID WAS DRIPPING FROM THE FIRST PORT CLOSEST TO THE SPIKE. NURSE REMOVED THE BAG FROM THE ROOM AND WHEN INSPECTED THE TUBING THE TUBING BROKE APART AT THE CONNECTION. THIS IS 2ND SET THAT HAD SAME PROBLEM IN EXACT SAME LOCATION. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14691637 ↗MalfunctionJun 15, 2022Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: EVENT 2: FLUID WAS DRIPPING FROM THE FIRST PORT CLOSEST TO THE SPIKE. NURSE REMOVED THE BAG FROM THE ROOM AND WHEN INSPECTED THE TUBING THE TUBING BROKE APART AT THE CONNECTION. THIS IS 2ND SET THAT HAD SAME PROBLEM IN EXACT SAME LOCATION. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14691559 ↗MalfunctionMay 18, 2022Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: EVENT 2: DETAILED INQUIRY DESCRIPTION: OUTLOOK PUMP SET TUBING SEPARATED AT UPPER Y SITE WHILE NURSE WAS HANGING CHEMO TO ATTACH TO MED PORT. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14427524 ↗MalfunctionMay 18, 2022Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: EVENT 1: DETAILED INQUIRY DESCRIPTION: OUTLOOK PUMP SET TUBING SEPARATED AT UPPER Y SITE WHILE NURSE WAS HANGING CHEMO TO ATTACH TO MED PORT. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14427414 ↗MalfunctionMay 17, 2022Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION: CHEMO LEAK USING ONGUARD SYSTEM. DETAILED INQUIRY DESCRIPTION: IFOSFAMIDE WAS INITIATED ON A PATIENT THAT HAD A V1921 LINE. NURSE WAS PREVIOUSLY RUNNING MESNA AND SHE USED Y SITE OF EXTENSION 354213. SHE STOPPED MESNA AND CONNECTED IFOSFOMIDE USING ONGUARD LUER ADAPTER 412114. NURSES SUSPECT THE PROBLEM IS MESNA CAUSING PRECIPITATION AT PORT EITHER IN EXTENSION LINE OR ONGUARD ADAPTOR. IN THE PAST THEY NOTICED THAT AFTER DISCONNECTING LINES WITH MESNA IF THEY WANTED TO REINITIATE INFUSION WITH MESNA THEY WILL HAVE SOME PRECIPITATES THAT WILL NOT ALLOW INFUSION AND THEREFORE RESULTED IN LEAKS AT PORT. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14414406 ↗MalfunctionApr 13, 2022Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: EVENT 3: BRIEF INQUIRY DESCRIPTION OUTLOOK PUMP SETS LEAKING. NO INJURY REPORTED BUT CHEMOTHERAPY LEAKED ON THE PATIENTS SKIN AND CLOTHES.
Patient problems: Chemical Exposure
MAUDE report 14102039 ↗MalfunctionApr 13, 2022Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: EVENT 1: BRIEF INQUIRY DESCRIPTION OUTLOOK PUMP SETS LEAKING. NO INJURY REPORTED.
Patient problems: Chemical Exposure
MAUDE report 14102038 ↗MalfunctionApr 13, 2022Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: EVENT 2: BRIEF INQUIRY DESCRIPTION. OUTLOOK PUMP SETS LEAKING. NO INJURY REPORTED BUT CHEMOTHERAPY LEAKED ON THE PATIENTS SKIN AND CLOTHES.
Patient problems: Chemical Exposure
MAUDE report 14102035 ↗MalfunctionDec 3, 2021Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT THE CASSETTE LEAKED. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12930285 ↗MalfunctionNov 15, 2021Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: EVENT 1: AN UNANNOUNCED SAMPLE WAS RECEIVED FOR LOT # 0061777155. THE ORIGINAL REPORT INDICATED THAT THE CASSETTE LEAKED ON THE PUMP SET. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12811057 ↗MalfunctionNov 15, 2021Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: EVENT 2: AN UNANNOUNCED SAMPLE WAS RECEIVED FOR LOT # 0061777155. THE ORIGINAL REPORT INDICATED THAT THE CASSETTE LEAKED ON THE PUMP SET. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12811054 ↗MalfunctionNov 15, 2021Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: EVENT 2: AN UNANNOUNCED SAMPLE WAS RECEIVED FOR LOT # 0061795338. THE ORIGINAL REPORT INDICATED THAT THE CASSETTE LEAKED ON THE PUMP SET. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12811051 ↗MalfunctionNov 15, 2021Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: EVENT 1: AN UNANNOUNCED SAMPLE WAS RECEIVED FOR LOT # 0061795338. THE ORIGINAL REPORT INDICATED THAT THE CASSETTE LEAKED ON THE PUMP SET. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12811049 ↗MalfunctionNov 9, 2021Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT THE CASSETTE LEAKED DURING CHEMO USE. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12778410 ↗MalfunctionNov 1, 2021Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: EVENT 2: IT WAS REPORTED THAT DUE TO A PUDDLE LEAKAGE OF LACTATED RINGER WAS DISCOVERED. NURSE WATCHED AND NOTICED THAT THE SOLUTION LEAKING WAS COMING FROM THE PORT. IT ONLY LEAKED WHEN PCA TUBING WAS CONNECTED/ENGAGED IN THE PORT. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12728864 ↗MalfunctionNov 1, 2021Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: EVENT 1: IT WAS REPORTED THAT DUE TO A PUDDLE LEAKAGE OF LACTATED RINGER WAS DISCOVERED. NURSE WATCHED AND NOTICED THAT THE SOLUTION LEAKING WAS COMING FROM THE PORT. IT ONLY LEAKED WHEN PCA TUBING WAS CONNECTED/ENGAGED IN THE PORT. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12728863 ↗MalfunctionOct 19, 2021Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT THE CASSETTE LEAKED. DETAILED INQUIRY DESCRIPTION A NURSE WENT TO SET UP AND PRIME IV TUBING FOR PATIENT IV ADMINISTRATION, AS SHE WAS PRIMING SHE NOTICED THE TUBING WAS LEAKING QUITE EXTENSIVELY. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12658003 ↗MalfunctionOct 11, 2021Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT THE CASSETTE LEAKED. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12605911 ↗MalfunctionOct 11, 2021Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT THE CASSETTE LEAKED. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12605906 ↗MalfunctionOct 11, 2021Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT THE CASSETTE LEAKED. THE SEQUENCE WAS ASSESSED AND IDENTIFIED AS NOT BEING THE DOT SEQUENCE ORIGINALLY NOTED IN INITIAL RECALL (4/2). THE LEAK WAS IDENTIFIED AS COMING FROM, WHERE THE RED ARROW IS POINTING BELOW. IT APPEARED AS A SMALL PUNCTURE OR INCISION AND THUS MY TEAM ASSUMED IT OCCURRED DURING TIME OF PLACEMENT IN PUMP. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12605899 ↗MalfunctionSep 27, 2021Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: EVENT 2: IT WAS REPORTED THAT LEAKAGE OCCURRED DURING PRIMING. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12532817 ↗MalfunctionSep 27, 2021Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: EVENT 1: IT WAS REPORTED THAT LEAKAGE OCCURRED DURING PRIMING. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12532816 ↗MalfunctionSep 15, 2021Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: "MISSING PART ON THE PLACE WHERE THE STAFF MEMBER PLACES THE TUBING INTO THE PUMP CAUSING THE FLUID IN THE TUBING TO COME OUT." NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12473330 ↗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 12419055 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.