Outlook® 354212Recalls & reported problems
B. Braun Medical Inc. · Outlook® Pump Set with 2 CARESITE® Needle-Free Injection Sites · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
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 a tubing set with two needleless injection ports for delivering IV fluids and medicines. The 35 reports mostly describe cracking or holes in the tubing and ports that let IV fluid or blood leak out, with no deaths or injuries. Three recalls name this device: 2 open ones, from October 2025 and June 2024, concern medication from a secondary IV container flowing back into the primary container and the set failing to prime; a third, from August 2021, is closed.
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
- 35
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 3
Summary
The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 04046964293832), received between Nov 23, 2016 and Jun 15, 2022 — classified as 35 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (16 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.
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-0709-2026 · 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-2376-2024 · 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-2544-2021 · Root cause: Under Investigation by firm · FDA record ↗
Most reported problems
Device problems
- Fluid/Blood Leak16
- Leak/Splash16
- Contamination /Decontamination Problem1
- Device Contamination with Chemical or Other Material1
- Device Operates Differently Than Expected1
Patient problems
- No Clinical Signs, Symptoms or Conditions26
- No Consequences Or Impact To Patient6
- No Known Impact Or Consequence To Patient2
- Exposure to Body Fluids1
Recent adverse event reports
The 25 most recent of 35 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 15, 2022Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: EVENT 1: 2 INSTANCES THIS PAST WEEK WHERE SIMILAR ISSUES OCCURRED WITH THE PRIMARY IV SETS. THE PROXIMAL IV PUSH PORTS ARE CRACKING AND CAUSING IV FLUIDS TO LEAK AT THE SITE FROM THAT PORT. I DO NOT HAVE THE ORIGINAL PACKAGING, AS THE ISSUE WAS IDENTIFIED AFTER THE TUBING WAS IN USE. FOR THESE 2 OCCURRENCES, THE BLOOD DID NOT BACK UP INTO THE TUBING. AND THE CRACK IS VISIBLE TO THE NAKED EYE WITH CLOSE VISUALIZATION. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14691562 ↗MalfunctionJun 15, 2022Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: EVENT 2: 2 INSTANCES THIS PAST WEEK WHERE SIMILAR ISSUES OCCURRED WITH THE PRIMARY IV SETS. THE PROXIMAL IV PUSH PORTS ARE CRACKING AND CAUSING IV FLUIDS TO LEAK AT THE SITE FROM THAT PORT. I DO NOT HAVE THE ORIGINAL PACKAGING, AS THE ISSUE WAS IDENTIFIED AFTER THE TUBING WAS IN USE. FOR THESE 2 OCCURRENCES, THE BLOOD DID NOT BACK UP INTO THE TUBING. AND THE CRACK IS VISIBLE TO THE NAKED EYE WITH CLOSE VISUALIZATION. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14691561 ↗MalfunctionJun 12, 2022Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT THERE WAS A TINY HOLE NEAR THE CARTRIDGE AREA OF THE PUMP THAT CAUSED A LEAK. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14672297 ↗MalfunctionJun 9, 2022Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: IV PAIN MEDS TO SECONDARY PORT(CLOSEST TO PT). HEARD A CRACK AND NOTICED PORT WAS LEAKING. WHEN IV MED WAS UNSCREWED THE PORT DIDN'T LEAK. CHECKED BY SCREWING EMPTY SYRINGE TO IT AND IT STARTED LEAKING AGAIN. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14649111 ↗MalfunctionDec 27, 2021Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT THE IV PUMP TUBING IS LEAKING BY THE CASSETTE. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13090730 ↗MalfunctionOct 19, 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 12658005 ↗MalfunctionOct 19, 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 12658004 ↗MalfunctionOct 19, 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 12658000 ↗MalfunctionOct 19, 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 12657999 ↗MalfunctionOct 11, 2021Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT WHEN BLOOD WAS BEING INFUSED THROUGH THE OUTLOOK IV PUMP SET 354212 THE CASSETTE LEAKED. BLOOD SPLATTERED ON NURSES CLOTHES BUT DID NOT ON THE PATIENT. NO INJURY REPORTED.
Patient problems: Exposure to Body Fluids
MAUDE report 12605894 ↗MalfunctionAug 12, 2021Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: EVENT 2: IT WAS REPORTED THAT DURING PRIMING WITH SODIUM CHLORIDE THE SET LEAKED. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12315690 ↗MalfunctionAug 12, 2021Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: EVENT 1: IT WAS REPORTED THAT DURING PRIMING WITH SODIUM CHLORIDE THE SET LEAKED. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12315675 ↗MalfunctionAug 12, 2021Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: EVENT 1: IT WAS REPORTED THAT DURING PRIMING WITH SODIUM CHLORIDE THE SET LEAKED. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12315674 ↗MalfunctionAug 12, 2021Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: EVENT 3: IT WAS REPORTED THAT DURING PRIMING WITH SODIUM CHLORIDE THE SET LEAKED. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12315652 ↗MalfunctionAug 12, 2021Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: EVENT 2: IT WAS REPORTED THAT DURING PRIMING WITH SODIUM CHLORIDE THE SET LEAKED. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12315642 ↗MalfunctionAug 12, 2021Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: EVENT 4: IT WAS REPORTED THAT DURING PRIMING WITH SODIUM CHLORIDE THE SET LEAKED. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12315640 ↗MalfunctionAug 10, 2021Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT THE SET LEAKED AT THE CASSETTE. NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12300086 ↗MalfunctionAug 10, 2021Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT THE SET LEAKED AT THE CASSETTE. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12300075 ↗MalfunctionAug 10, 2021Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT THE SET LEAKED AT THE CASSETTE. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12300069 ↗MalfunctionJul 15, 2021Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT THE SET LEAKED CHEMOTHERAPY. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12172291 ↗MalfunctionJun 17, 2021Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 2: END USER REPORTS, "WE HAD TWO BLOOD INFUSIONS THAT LEAKED BLOOD FROM THE CASSETTE WHEN THE TUBING WAS REMOVED FROM THE PUMP." NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12018297 ↗MalfunctionJun 17, 2021Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: END USER REPORTS, CASSETTE OF OUTLOOK IV PUMP SET IS LEAKING (B)(4). DETAILED INQUIRY DESCRIPTION: CASSETTE IS LEAKING IN OUTLOOK IV PUMP SET (B)(4), DURING ADMINISTRATION OF BLOOD/CHEMO. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12018293 ↗MalfunctionJun 17, 2021Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 1: END USER REPORTS, "WE HAD TWO CHEMO LEAKAGES, ONE WAS WHEN THE TUBING WAS BEING PRIMED IN PHARMACY AND THE OTHER WAS WHEN IT WAS BEING REMOVED FROM THE IV PUMP. NONE OF THE LEAKAGES ADVERSELY IMPACTED THE PATIENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12018292 ↗MalfunctionJun 17, 2021Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 1: END USER REPORTS, "WE HAD TWO BLOOD INFUSIONS THAT LEAKED BLOOD FROM THE CASSETTE WHEN THE TUBING WAS REMOVED FROM THE PUMP." NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12018291 ↗MalfunctionJun 17, 2021Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 2: END USER REPORTS, "WE HAD TWO CHEMO LEAKAGES, ONE WAS WHEN THE TUBING WAS BEING PRIMED IN PHARMACY AND THE OTHER WAS WHEN IT WAS BEING REMOVED FROM THE IV PUMP. NONE OF THE LEAKAGES ADVERSELY IMPACTED THE PATIENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12018290 ↗
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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 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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