EXACTAMIX H938742Recalls & reported problems

Summary

The FDA's MAUDE database contains 93 adverse event reports that list this exact device (DI 00085412477268), received between Jan 31, 2018 and Jan 14, 2025 — classified as 93 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (88 reports).

37 other recalls cover devices cleared under the same FDA submission (K900585); they may or may not involve this specific model.

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.

Most reported problems

Recent adverse event reports

The 25 most recent of 93 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 14, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN EXACTAMIX 4000 ML EVA (ETHYLENE-VINYL ACETATE) TPN (TOTAL PARENTERAL NUTRITION) BAG LEAKED ON THE SIDE OF THE BAG. THIS OCCURRED PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21149076 ↗
• MalfunctionOct 9, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN EXACTAMIX 4000 ML EVA TPN BAG LEAKED AT THE BOTTOM CORNER. IT WAS DISCOVERED IT IMMEDIATELY AFTER COMPOUNDING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20409306 ↗
• MalfunctionOct 4, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN EXACTAMIX 4000ML EVA (ETHYLENE VINYL ACETATE) TPN (TOTAL PARENTERAL NUTRITION) WAS LEAKING FROM AN UNSPECIFIED LOCATION. THE LEAK WAS DISCOVERED PRIOR TO LEAVING THE PHARMACY BEFORE PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20372808 ↗
• MalfunctionMay 22, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN EXACTAMIX 4000 ML EVA TPN BAG LEAKED AT THE UPPER RIGHT CORNER. THIS WAS OBSERVED BEFORE PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19378795 ↗
• MalfunctionFeb 13, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT TWO (2) EXACTAMIX 4000 ML EVA (ETHYLENE-VINYL ACETATE) TPN (TOTAL PARENTERAL NUTRITION) BAGS LEAKED AT THE MIDDLE/MEMBRANE PORT. THIS WAS OBSERVED AFTER COMPOUNDING, PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18696526 ↗
• MalfunctionFeb 1, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT FOUR (4) EXACTAMIX 4000 ML EVA (ETHYLENE VINYL ACETATE) TPN (TOTAL PARENTERAL NUTRITION) BAGS LEAKED FROM THE MIDDLE PORT. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18625875 ↗
• MalfunctionOct 4, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED AN EXACTAMIX 4000 ML EVA TPN BAG LEAKED. THE LEAK WAS DESCRIBED AS ¿SWEATING¿; HOWEVER, THE USER COULD NOT IDENTIFY THE EXACT LOCATION OF THE LEAK. THE EVENT OCCURRED WHEN THE BAG WAS REMOVED FROM THE REFRIGERATOR PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17873994 ↗
• MalfunctionSep 29, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A 4000ML EVA (ETHYL VINYL ACETATE) TPN (TOTAL PARENTERAL NUTRITION) BAG LEAKED TPN FROM THE BOTTOM SEAM. THIS WAS DISCOVERED DURING PATIENT USE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17848188 ↗
• MalfunctionSep 13, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A 4000ML EVA (ETHYL VINYL ACETATE) TPN (TOTAL PARENTERAL NUTRITION) BAG LEAKED FROM THE MIDDLE PORT. THIS WAS DISCOVERED DURING AN UNSPECIFIED PROCESS STEP. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17739898 ↗
• MalfunctionSep 12, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A 4000ML EVA (ETHYL VINYL ACETATE) TPN (TOTAL PARENTERAL NUTRITION) BAG WAS LEAKING. THIS ISSUE WAS IDENTIFIED DURING PATIENT INFUSION. THE BAG WAS REMOVED AND A NEW BAG WAS USED. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17733371 ↗
• MalfunctionAug 21, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A 4000ML EVA (ETHYL VINYL ACETATE) TPN (TOTAL PARENTERAL NUTRITION) BAG LEAKED FROM THE SPIKE PORT. THIS LEAK WAS "IN THE AREA THAT THE CAP WOULD'VE BROKEN OFF AT". THE ISSUE WAS OBSERVED AFTER THE BAG WAS COMPLETELY COMPOUNDED, BEFORE PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17586379 ↗
• MalfunctionJul 17, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT FOUR (4) 4000ML EVA (ETHYL VINYL ACETATE) TPN (TOTAL PARENTERAL NUTRITION) BAGS WERE LEAKING FROM THE MIDDLE PORT. THE ISSUE WAS IDENTIFIED AFTER MIXING THE TPN PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17334901 ↗
• MalfunctionApr 22, 2022Precipitate in Device or Device Ingredient; Precipitate in Device or Device Ingredient

  IT WAS REPORTED THAT THE SOLUTION IN A 4000ML EVA (ETHYL VINYL ACETATE) TPN (TOTAL PARENTERAL NUTRITION) BAG WAS CLOUDY WITH WHITE PRECIPITATE. THE CLOUDY SOLUTION WAS OBSERVED DURING THE PHARMACIST CHECK AFTER PREPARATION PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14189560 ↗
• MalfunctionOct 26, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A 4000 ML EVA (ETHYL VINYL ACETATE) TPN (TOTAL PARENTERAL NUTRITION) BAG LEAKED. FROM THE WELD. THE LEAK WAS DISCOVERED AFTER PACKING PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12698181 ↗
• MalfunctionSep 15, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A 4000 ML EVA (ETHYL VINYL ACETATE) TPN (TOTAL PARENTERAL NUTRITION) BAG WAS LEAKING FROM THE TOP SEAM. THE LEAK WAS DISCOVERED PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12475243 ↗
• MalfunctionSep 15, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A 4000ML EVA (ETHYL VINYL ACETATE) TPN (TOTAL PARENTERAL NUTRITION) BAG WAS LEAKING FROM THE TOP SEAM. THE LEAK WAS DISCOVERED PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12475198 ↗
• MalfunctionFeb 26, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THREE (3) 4000ML EVA (ETHYL VINYL ACETATE) TPN (TOTAL PARENTERAL NUTRITION) BAGS WERE LEAKING FROM UNSPECIFIED LOCATIONS. THE LEAKS WERE DISCOVERED DURING SETUP AND PREPARATION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11386860 ↗
• MalfunctionDec 10, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A 4000ML EVA (ETHYL VINYL ACETATE) TPN (TOTAL PARENTERAL NUTRITION) BAG LEAKED FROM THE UNSPECIFIED LOCATION. THE LEAK WAS DISCOVERED DURING PATIENT USE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10985954 ↗
• MalfunctionDec 8, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A 4000ML EVA (ETHYL VINYL ACETATE) TPN (TOTAL PARENTERAL NUTRITION) BAG WAS LEAKING FROM AN UNSPECIFIED LOCATION. THE LEAK WAS DISCOVERED PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 10971157 ↗
• MalfunctionNov 23, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A 4000ML EVA (ETHYL VINYL ACETATE) TPN (TOTAL PARENTERAL NUTRITION) BAG WAS LEAKING AT THE MIDDLE PORT. THE LEAK WAS DISCOVERED AFTER THE BAG WAS FILLED AND HUNG WITH THE PORT FACING DOWN, PRIOR TO PATIENT USE. THE BAG WAS FILLED WITH AN UNSPECIFIED SOLUTION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 10885470 ↗
• MalfunctionNov 20, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT TWENTY-SIX (26) UNITS OF 4000ML EVA (ETHYL VINYL ACETATE) TPN (TOTAL PARENTERAL NUTRITION) BAGS WERE LEAKING COMING AT THE PORT. THE LEAKS WERE DISCOVERED DURING SETUP AND PREPARATION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 10880215 ↗
• MalfunctionNov 20, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A 4000ML EVA (ETHYL VINYL ACETATE) TPN (TOTAL PARENTERAL NUTRITION) BAG LEAKED FORM AN UNSPECIFIED LOCATION. THIS WAS FURTHER DESCRIBED AS ¿THERE APPEARED TO BE NO ISSUES AT THE TIME OF DELIVERY AND THE BAG WAS HUNG AND ADMINISTERED TO THE PATIENT. THE FOLLOWING MORNING WHEN THE NURSE WAS CHECKING ON THE PATIENT, THEY NOTICED THAT SOME OF THE BAG CONTENTS HAD LEAKED INTO THE OVERPOUCH¿. THIS WAS IDENTIFIED DURING A PATIENT INFUSION. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE..

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10879913 ↗
• MalfunctionNov 3, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A 4000ML EVA (ETHYL VINYL ACETATE) TPN (TOTAL PARENTERAL NUTRITION) BAG WAS LEAKING FROM AN UNSPECIFIED LOCATION. THE LEAK WAS DISCOVERED DURING AN UNSPECIFIED PROCESS STEP. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10780268 ↗
• MalfunctionOct 12, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A 4000ML EVA (ETHYL VINYL ACETATE) TPN (TOTAL PARENTERAL NUTRITION) BAG WAS DEFECTIVE. THE DEFECT WAS FURTHER DESCRIBED AS LEAK COMING FROM AN UNKNOWN LOCATION. THIS ISSUE WAS IDENTIFIED DURING SETUP, AND PREPARATION PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 10662858 ↗
• MalfunctionSep 25, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A 4000ML EVA (ETHYL VINYL ACETATE) TPN (TOTAL PARENTERAL NUTRITION) BAG WAS LEAKING FROM AN UNSPECIFIED LOCATION. THE LEAK WAS DISCOVERED AT THE INPATIENT PHARMACY AFTER BEING COMPOUNDED. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 10590294 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K900585. One submission often covers many models, so check the product and lot details in each record.

• Z-0167-2020 · Sep 18, 2019 · Terminated
  EXACTAMIX Empty EVA (Ethylene Vinyl Acetate) TPN Bag with the following product code and sizes: 1. H938737, 250mL; 2. H938738, 500mL; 3. H938739, 1000mL; 4. H938740, 2000
• Z-0367-2019 · Sep 12, 2018 · Terminated
  EXACTAMIX Empty EVA Bags - 3000 mL Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a patient through an intravascular administr
• Z-0366-2019 · Sep 12, 2018 · Terminated
  EXACTAMIX Empty EVA Bags - 2000 mL Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a patient through an intravascular administr
• Z-0365-2019 · Sep 12, 2018 · Terminated
  EXACTAMIX Empty EVA Bags - 1000 mL Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a patient through an intravascular administr
• Z-0364-2019 · Sep 12, 2018 · Terminated
  EXACTAMIX Empty EVA Bags - 500 mL - Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a patient through an intravascular administ
• Z-0363-2019 · Sep 12, 2018 · Terminated
  EXACTAMIX Empty EVA Bags - 250 mL Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a patient through an intravascular administra
• Z-0007-2017 · Aug 24, 2016 · Terminated
  0.2 Micron Filter, 50 mm Product Usage: The 0.2 Micron Filter is a bacteria and particulate filter for aqueous solutions. It attaches to a standard Baxter Pharmacy Pump Tube Set.
• Z-2165-2013 · Aug 22, 2013 · Terminated
  Baxa Vial Adapter, 14mm - Luer Lock, Order No. REF: 90, Quantity: 50 each, Single Use. Product Code H93890. Used as a needleless access device for reconstitution and drug transfer
• Z-1966-2011 · Mar 8, 2011 · Terminated
  ExactaMix EVA Container, 2000mL, REF: 740, Sterile R, Baxa Corporation, Englewood, CO 80112. A plastic container used to hold large-volume sterile solutions to be administered to
• Z-1963-2011 · Mar 8, 2011 · Terminated
  ExactaMix EVA Container, 250mL, REF: 737, Sterile R, Baxa Corporation, Englewood, CO 80112. A plastic container used to hold large-volume sterile solutions to be administered to
• Z-1964-2011 · Mar 8, 2011 · Terminated
  ExactaMix EVA Container, 500mL, REF: 738, Sterile R, Baxa Corporation, Englewood, CO 80112. A plastic container used to hold large-volume sterile solutions to be administered to
• Z-1967-2011 · Mar 8, 2011 · Terminated
  ExactaMix EVA Container, 3000mL, REF: 741, Sterile R, Baxa Corporation, Englewood, CO 80112. A plastic container used to hold large-volume sterile solutions to be administered to
• Z-1962-2011 · Mar 8, 2011 · Terminated
  ExactaMix EVA Container, Calibration Bag, REF: 735, Sterile R, Baxa Corporation, Englewood, CO 80112. A plastic container used to hold large-volume sterile solutions to be adminis
• Z-1965-2011 · Mar 8, 2011 · Terminated
  ExactaMix EVA Container, 1000mL, REF: 739, Sterile R, Baxa Corporation, Englewood, CO 80112. A plastic container used to hold large-volume sterile solutions to be administered to
• Z-2145-2010 · May 26, 2010 · Terminated
  Exacta-Mix Calibration Bag, Sterile R, non-pyrogenic fluid path, 250 mL Reorder No. H938 371 3, Manufactured for Baxa Corporation.

…and 22 more.