Medex MX448HFBRecalls & reported problems
Icu Medical, Inc. · Class 2
Quick summary
This ICU Medical Medex MX448HFB is a lipid/TPN filter used with infusion lines to let fat and nutrition fluids pass through an IV or PICC line. The 27 reports mostly describe leaking at the connections where the filter meets IV tubing, along with flow that stops or gets blocked. Three reports involve injuries and none describe deaths. There are no recalls naming this device, and no reports were filed in the past 12 months.
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
- 27
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10351688507457), received between Apr 20, 2017 and May 22, 2025 — classified as 3 injuries, 24 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (14 reports).
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
Most reported problems
Device problems
- Fluid/Blood Leak14
- Leak/Splash4
- Obstruction of Flow4
- Complete Blockage2
- Disconnection2
- No Flow2
- Air/Gas in Device1
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions15
- No Consequences Or Impact To Patient9
- Insufficient Information3
Recent adverse event reports
The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 22, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT LIPIDS STARTED LEAKING WHERE THE REGULAR IV TUBING MEETS THE LIPID FILTER ON A PCVC LINE. ALSO, THE LIPIDS LEAKED AT CONNECTION BETWEEN REGULAR BAXTER IV TUBING AND MEDEX MICRON LIPID FILTER. THERE WERE UNKNOWN PATIENT HARMS OR ADVERSE EVENTS REPORTED AS A RESULT OF THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22070349 ↗MalfunctionMar 25, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE LIPID FILTER WAS LEAKING WHILE CONNECTED TO PICC LINE. THIS WAS NOT A LABORATORY DEVICE OR LABORATORY TEST. ADVERSE PATIENT EFFECTS ARE UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21694148 ↗MalfunctionFeb 18, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT LIPIDS LEAKING AT CONNECTION BETWEEN REGULAR BAXTER IV TUBING AND MEDEX MICRON LIPID FILTER. THERE WERE UNKNOWN PATIENT HARM OR ADVERSE EVENTS REPORTED AS A RESULT OF THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21401046 ↗MalfunctionFeb 18, 2025Complete Blockage; Air/Gas in Device; Complete Blockage; Air/Gas in Device
IT WAS REPORTED THAT UPON VISUAL INSPECTION THE FILTER APPEARED ABNORMAL WHICH APPEARED TO HAVE LOTS OF AIR IN IT. LIPIDS IN TUBING DID NOT APPEAR TO BE MOVING PAST BIFUSE THAT THEY WERE ATTACHED TO WITH TPN EVEN AFTER CLAMPING TPN. THERE WERE NO PATIENT HARM OR ADVERSE EVENTS REPORTED AS A RESULT OF THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21397910 ↗MalfunctionFeb 18, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT LIPIDS STARTED LEAKING WHERE THE REGULAR IV TUBING MEETS THE LIPID FILTER ON A PCVC LINE. THERE WERE UNKNOWN PATIENT HARMS OR ADVERSE EVENTS REPORTED AS A RESULT OF THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21393840 ↗MalfunctionFeb 11, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE LIPID FILTER WAS LEAKING WHILE CONNECTED TO PICC LINE. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21357188 ↗MalfunctionJan 5, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT UPON VISUAL INSPECTION DURING FIRST CARE TIME, YELLOW FLUID NOTED ON THE SHEETS UNDERNEATH THE TRI-FUSE AREA. PROVIDER NOTIFIED ABOUT LEAKING TUBING/CONNECTION. PADS PLACED UNDER LINES, FLUID APPARENTLY LEAKING FROM CONNECTION BETWEEN TPN FILTER AND ANTI-SIPHON VALVE. TPN/IL TAKEN DOWN AND NEW CLEAR FLUID HUNG. THERE WAS PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.
Patient problems: Insufficient Information
MAUDE report 18457460 ↗MalfunctionNov 1, 2023Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture
IT WAS REPORTED THAT DURING USE FLUID WAS LEAKING FROM THE CONNECTION BETWEEN TOTAL PARENTERAL NUTRITION FILTER AND ANTI-SIPHON VALVE. TOTAL PARENTERAL NUTRITION PER "INTERLEUKIN" TAKEN DOWN AND NEW CLEAR FLUID HUNG. NO ADVERSE PATIENT EFFECTS WERE REPORTED BY THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18049674 ↗MalfunctionMay 30, 2023Complete Blockage; Obstruction of Flow; Complete Blockage; Obstruction of Flow
IT WAS REPORTED THAT THE LIPID LINE KEPT BEEPING OCCLUDED. ATTEMPTED TO FLUSH THE LIPIDS FROM TWO DIFFERENT PORT SITES, BUT IT JUST KEPT BACKING UP INTO THE RUBBER PART OF THE TUBING INTO A "BIG BUBBLE". CHANGED TO A NEW EXTENSION SET WITH A FILTER. NO ADVERSE PATIENT EFFECTS WERE REPORTED BY THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17019234 ↗MalfunctionMay 4, 2023Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED THAT DURING INFUSION THE IV PUMP WAS ALARMING OCCLUSION. CLAMPS WERE OPEN, LINE PATENT, AND NO KINKS. UPON DISCONNECTING THE LINE THERE WAS "NO FLOW". THE CUSTOMER CHANGED THE FILTER, AND THE LINE BEGAN TO FLOW FREELY. THE CUSTOMER NOTED THAT THE REPORTED DEVICE WAS A SUBSTITUTE PRODUCT, AND IT WAS "SLIGHTLY SMALLER" THAN THEIR USUAL FILTER AND HAVE SINCE SWITCHED BACK TO THEIR ORIGINAL FILTER. NO ADVERSE PATIENT EFFECTS WERE REPORTED BY THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16872409 ↗MalfunctionMay 4, 2023Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED THAT DURING INFUSION THE IV PUMP WAS ALARMING OCCLUSION. CLAMPS WERE OPEN, LINE PATENT, AND NO KINKS. UPON DISCONNECTING THE LINE THERE WAS "NO FLOW". THE CUSTOMER CHANGED THE FILTER, AND THE LINE BEGAN TO FLOW FREELY. THE CUSTOMER NOTED THAT THE REPORTED DEVICE WAS A SUBSTITUTE PRODUCT, AND IT WAS "SLIGHTLY SMALLER" THAN THEIR USUAL FILTER AND HAVE SINCE SWITCHED BACK TO THEIR ORIGINAL FILTER. NO ADVERSE PATIENT EFFECTS WERE REPORTED BY THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16868974 ↗MalfunctionJan 17, 2023Break; Fluid/Blood Leak; Improper Flow or Infusion; Break; Fluid/Blood Leak; Improper Flow or Infusion
IT WAS REPORTED THAT THE PATIENT WAS CONNECTED TO 1L BOLUS OF NORMAL SALINE IN HALLWAY BED ACROSS FROM NURSE'S STATION. WHILE INFUSING, DEFECTIVE IV TUBING BROKE IN HALF ABOUT 5 INCHES FROM HUB CONNECTION TO THE PATIENT. FLUID LEAKED OUT ONTO FLOOR AND BLOOD INTO TUBING STILL CONNECTED TO PATIENT. BREAK WAS NOTICED IMMEDIATELY AND TUBING WAS DISCONNECTED. FLUIDS CLEANED UP AND PROPERLY AND DISPOSED OF. NO HARM TO PATIENT, IV CATHETER UNDAMAGED AND REMAINED INTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16186544 ↗MalfunctionAug 4, 2022Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE DEVICE WAS LEAKING FLUID. LIPID FILTER TO HAVE A SMALL DROP OF LIPIDS LEAKING FROM CONNECTION SITE. NO PATIENT INJURY WAS REPORTED.
Patient problems: Insufficient Information
MAUDE report 15166377 ↗MalfunctionAug 4, 2022Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE DEVICE WAS LEAKING FLUID. LIPID FILTER TO HAVE A SMALL DROP OF LIPIDS LEAKING FROM CONNECTION SITE. NO PATIENT INJURY WAS REPORTED.
Patient problems: Insufficient Information
MAUDE report 15166313 ↗MalfunctionApr 1, 2022Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED ON MEDWATCH (B)(4) IV LIPID FILTER NOT ALLOWING LIPIDS TO PASS THROUGH FROM IV TUBING INTO THE FILTER. CHANGED FILTER WITH DIFFERENT LOT NUMBER, AND STILL DID NOT WORK. NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13977981 ↗MalfunctionMar 4, 2022No Flow; No Flow
IT WAS REPORTED THAT THE IV FLUID IS NOT RUNNING THROUGH THE ADMINISTRATION SET. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13672452 ↗MalfunctionMar 4, 2022No Flow; No Flow
IT WAS REPORTED THAT THE IV FLUID IS NOT RUNNING THROUGH THE ADMINISTRATION SET. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13670244 ↗MalfunctionJun 1, 2021Fluid/Blood Leak; Insufficient Flow or Under Infusion; Fluid/Blood Leak; Insufficient Flow or Under Infusion
INFORMATION RECEIVED A SMITHS MEDICAL INFUSION EXTENSION SETS AND DISPOSABLES/MEDEX EXTENSION SETS SINGLE LINE HAD LEAKING OF MEDICATION. REPORTED BY PATIENTS FATHER AT 0955 , HE CALLED THIS RN TO BEDSIDE TO NOTIFY HER THAT PATIENT IS LEAKING FROM SMOFLIPID LINE. UPON ASSESSMENT, IT APPEARED THAT LIPIDS WERE BACKFLOWING INTO LINE, THEREFORE CAUSING PRESSURE TO BUILD. RN ASSISTED THIS RN IN CHANGING OUT THE FILTER. SMOFLIPIDS WERE INFUSING WELL AFTER CHANGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11916581 ↗MalfunctionAug 9, 2017Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE FILTER OF A MEDEX¿ ULTRA¿ SMALL BORE EXTENSION SET WAS LEAKING. IT WAS NOTED THAT THE PATIENT'S BED WAS WET AROUND TWELVE HOURS AFTER INFUSION WAS STARTED. THERE WAS NO LEAKAGE NOTED FROM ANY OF THE CONNECTIONS. UPON INSPECTION, THE LIPID FILTER WAS CLOGGED WITH BLOOD. THE WET ON THE BED LOOK MORE LIKE TOTAL PARENTERAL NUTRITION (TPN). IT APPEARS THAT THE FILTER WAS LEAKING SOMEWHERE, CAUSING THE TPN AND BLOOD TO BACK UP. NONE OF THE PUMPS ALARMED. NO INJURY WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6776959 ↗MalfunctionAug 9, 2017Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE FILTER OF A MEDEX¿ ULTRA¿ SMALL BORE EXTENSION SET WAS LEAKING. IT WAS NOTED THAT THE PATIENT'S BED WAS WET AROUND TWELVE HOURS AFTER INFUSION WAS STARTED. THERE WAS NO LEAKAGE NOTED FROM ANY OF THE CONNECTIONS. UPON INSPECTION, THE LIPID FILTER WAS CLOGGED WITH BLOOD. THE WET ON THE BED LOOK MORE LIKE TOTAL PARENTERAL NUTRITION (TPN). IT APPEARS THAT THE FILTER WAS LEAKING SOMEWHERE, CAUSING THE TPN AND BLOOD TO BACK UP. NONE OF THE PUMPS ALARMED. NO INJURY WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6776949 ↗MalfunctionAug 9, 2017Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE FILTER OF A MEDEX ULTRA SMALL BORE EXTENSION SET WAS LEAKING. IT WAS NOTED THAT THE PATIENT'S BED WAS WET AROUND TWELVE HOURS AFTER INFUSION WAS STARTED. THERE WAS NO LEAKAGE NOTED FROM ANY OF THE CONNECTIONS. UPON INSPECTION, THE LIPID FILTER WAS CLOGGED WITH BLOOD. THE WET ON THE BED LOOK MORE LIKE TOTAL PARENTERAL NUTRITION (TPN). IT APPEARS THAT THE FILTER WAS LEAKING SOMEWHERE, CAUSING THE TPN AND BLOOD TO BACK UP. NONE OF THE PUMPS ALARMED. NO INJURY WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6776942 ↗MalfunctionMay 8, 2017Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT A MEDEX¿ ULTRA¿ SMALL BORE EXTENSION SET WAS LEAKING FROM THE SEAM OF THE FEMALE PART OF THE FILTER. THE LEAK OCCURRED AFTER THE DEVICE HAD BEEN IN USE FOR FIVE TO SEVEN HOURS. THE FILTER WAS REMOVED AND REPLACED. DEX WAS OBTAINED TO CHECK BLOOD SUGAR. THE PATIENT WAS MONITORED FOR SIGNS OF SEPSIS. NO INJURY WAS REPORTED. SEE MFR: 3012307300-2017-01018 AND 3012307300-2017-01044.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6552446 ↗MalfunctionMay 8, 2017Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT A MEDEX¿ ULTRA¿ SMALL BORE EXTENSION SET WAS LEAKING FROM THE SEAM OF THE FEMALE PART OF THE FILTER. THE LEAK OCCURRED AFTER THE DEVICE HAD BEEN IN USE FOR FIVE TO SEVEN HOURS. THE FILTER WAS REMOVED AND REPLACED. DEX WAS OBTAINED TO CHECK BLOOD SUGAR. THE PATIENT WAS MONITORED FOR SIGNS OF SEPSIS. NO INJURY WAS REPORTED. SEE MFR: 3012307300-2017-01016 AND 3012307300-2017-01017.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6552437 ↗MalfunctionMay 8, 2017Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT A MEDEX¿ ULTRA¿ SMALL BORE EXTENSION SET WAS LEAKING FROM THE SEAM OF THE FEMALE PART OF THE FILTER. THE LEAK OCCURRED AFTER THE DEVICE HAD BEEN IN USE FOR FIVE TO SEVEN HOURS. THE FILTER WAS REMOVED AND REPLACED. DEX WAS OBTAINED TO CHECK BLOOD SUGAR. THE PATIENT WAS MONITORED FOR SIGNS OF SEPSIS. NO INJURY WAS REPORTED. SEE MFR: 3012307300-2017-01017 AND 3012307300-2017-01044.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6552434 ↗InjuryApr 20, 2017Disconnection; Disconnection
IT WAS REPORTED THAT THE MEDEX¿ ULTRA¿ SMALL BORE EXTENSION SET FILTER DISCONNECTED FROM THE PATIENT IMMEDIATELY UPON USE. IT WAS REPORTED THAT MEDICAL INTERVENTION WAS REQUIRED, BUT IT WAS UNCLEAR WHAT THE INTERVENTION WAS. NO PATIENT INJURY WAS REPORTED. SEE MFR: 3012307300-2017-00868 AND 3012307300-2017-00870.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6508915 ↗
Other Filter, infusion line devices
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- INTERLINK 1C8740Baxter International Inc. · Filter, infusion line10 reports
- NA 2N3342Baxter International Inc. · Filter, infusion line8 reports
- FLUID SYSTEMS ACCESSORIES 2N3368Baxter Healthcare Corporation · Filter, infusion line5 reports
- Medex FS113Icu Medical, Inc. · Filter, infusion line3 reports
- NA 2N3347Baxter International Inc. · Filter, infusion line2 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.