Blood Administration Set 477005Recalls & reported problems
B. Braun Medical Inc. · Y-TYPE BLOOD, OUTLOOK PUMP SET, CARESITE · Class 2
All models of Blood Administration Set (24)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This B. Braun Outlook Y-type blood pump set has 40 adverse event reports, all malfunctions, with no deaths and no injuries. Reports describe tubing or filter parts leaking or breaking during use, sometimes with blood loss but no reported injury. There are 2 recalls, both now closed: one starting August 2021 for leakage in the cassette, and one starting November 2019 for leakage at the blood-filter joint.
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
- 40
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 04046955202799), received between May 1, 2019 and Feb 3, 2022 — classified as 40 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (32 reports).
2 FDA recall records 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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-2553-2021 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Nov 20, 2019Terminated
Potential for leakage at the joint between the blood filters and tubing
Z-0935-2020 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
Most reported problems
Device problems
- Fluid/Blood Leak32
- Leak/Splash8
Patient problems
- No Clinical Signs, Symptoms or Conditions20
- No Known Impact Or Consequence To Patient18
- Hemorrhage/Blood Loss/Bleeding1
- No Patient Involvement1
Recent adverse event reports
The 25 most recent of 40 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 3, 2022Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT THE TUBING LEAKED FROM THE CASSETTE. NO INJURY REPORTED. RESPONSE FROM CUSTOMER; NO BLOOD WAS LOST FOLLOWING EVENT, AND THE PATIENT WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13445986 ↗MalfunctionDec 27, 2021Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT THE FILTER BROKE OFF WHILE IN USE. MINIMAL BLOOD LOSS. THE BREAK WAS FOUND WHEN THE PATIENT'S BLOOD PRESSURE CUFF WAS IN USE AND BLOOD BEGAN BACKING UP IN THE TUBING. THE TUBING WAS CLAMPED IMMEDIATELY. NO INJURY REPORTED.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 13090733 ↗MalfunctionDec 27, 2021Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT THE FILTER BROKE OFF OF TUBING WHILE RN WAS HYDRATING THE PATIENT WITH IV FLUIDS FOR AN EPIDURAL. ABOUT 100 MLS OF LACTATED RINGERS WAS LOST. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13090728 ↗MalfunctionDec 15, 2021Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION: FLUID LEAKING OUT OF DISC PIECE; DISC PIECE SNAPPED OFF. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13010202 ↗MalfunctionSep 2, 2021Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: "OUTLOOK CASSETTE LEAKING". NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12419050 ↗MalfunctionAug 12, 2021Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT THE TUBING LEAKED AT PUMP SEGMENT. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12315635 ↗MalfunctionAug 11, 2021Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT THE TUBING LEAKED BLOOD DURING USE. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12306404 ↗MalfunctionAug 10, 2021Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT THE TUBING LEAKED BLOOD DURING USE. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12304004 ↗MalfunctionJul 28, 2021Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT THE BLOOD SET CASSETTE BROKE AND LEAKED. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12237627 ↗MalfunctionJul 28, 2021Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT THE BLOOD SET LEAKED. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12237625 ↗MalfunctionJul 15, 2021Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 2: IT WAS REPORTED THAT THE BLOOD SET LEAKED. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12172289 ↗MalfunctionJul 15, 2021Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 1: IT WAS REPORTED THAT THE BLOOD SET LEAKED. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12172288 ↗MalfunctionJul 15, 2021Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT THE BLOOD SET LEAKED. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12172287 ↗MalfunctionJul 15, 2021Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT THE BLOOD SET LEAKED. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12172283 ↗MalfunctionJun 23, 2021Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT THE BLOOD SET LEAKED. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12053916 ↗MalfunctionJun 21, 2021Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT THE TUBING LEAKS AT THE CONNECTION PORT SITE. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12036921 ↗MalfunctionNov 9, 2020Fluid/Blood Leak; Fluid/Blood Leak
LEAKAGE OF THE BLOOD SET DEVICE WAS IDENTIFIED: AS REPORTED BY THE USER FACILITY: "THE TUBING IS LEAKING IV FLUID FROM WHERE THE Y MEETS THE FILTER CHAMBER AT THE TOP."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10810497 ↗MalfunctionNov 9, 2020Fluid/Blood Leak; Fluid/Blood Leak
EVENT 4: LEAKAGE OF THE BLOOD SET DEVICE WAS IDENTIFIED: AS REPORTED BY THE USER FACILITY: "THE TUBING IS LEAKING IV FLUID FROM WHERE THE Y MEETS THE FILTER CHAMBER AT THE TOP."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10810482 ↗MalfunctionNov 9, 2020Fluid/Blood Leak; Fluid/Blood Leak
EVENT 3: LEAKAGE OF THE BLOOD SET DEVICE WAS IDENTIFIED: AS REPORTED BY THE USER FACILITY: "THE TUBING IS LEAKING IV FLUID FROM WHERE THE Y MEETS THE FILTER CHAMBER AT THE TOP."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10810464 ↗MalfunctionNov 9, 2020Fluid/Blood Leak; Fluid/Blood Leak
EVENT 1: LEAKAGE OF THE BLOOD SET DEVICE WAS IDENTIFIED: AS REPORTED BY THE USER FACILITY: "THE TUBING IS LEAKING IV FLUID FROM WHERE THE Y MEETS THE FILTER CHAMBER AT THE TOP."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10810459 ↗MalfunctionNov 9, 2020Fluid/Blood Leak; Fluid/Blood Leak
EVENT 2: LEAKAGE OF THE BLOOD SET DEVICE WAS IDENTIFIED: AS REPORTED BY THE USER FACILITY: "THE TUBING IS LEAKING IV FLUID FROM WHERE THE Y MEETS THE FILTER CHAMBER AT THE TOP."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10810421 ↗MalfunctionJun 9, 2020Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT THE SET LEAKED. NO INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10132699 ↗MalfunctionFeb 20, 2020Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 2: DURING INFUSION OF LACTATED RINGERS, THE NURSE NOTED FLUID WAS LEAKING AT THE POINT WHERE THE Y TUBING ENTERS THE BLOOD FILTER. THE INFUSION WAS STOPPED AND THE TUBING WAS CHANGED. NO INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9731952 ↗MalfunctionFeb 20, 2020Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 1: DURING INFUSION OF LACTATED RINGERS, THE NURSE NOTED FLUID WAS LEAKING AT THE POINT WHERE THE Y TUBING ENTERS THE BLOOD FILTER. THE INFUSION WAS STOPPED AND THE TUBING WAS CHANGED. NO INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9731949 ↗MalfunctionJan 29, 2020Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT THE BLOOD SET LEAKED DURING USE. NO INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9645287 ↗
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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 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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