EXACTAMIX H938743Recalls & reported problems

Summary

The FDA's MAUDE database contains 87 adverse event reports that list this exact device (DI 00085412477275), received between Mar 11, 2019 and Jan 2, 2025 — classified as 87 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (87 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 87 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 2, 2025Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  IT WAS REPORTED THAT THE SHAPE OF THE PORT OF AN UNSPECIFIED QUANTITY OF EXACTAMIX 5000 ML EVA (ETHYLENE VINYL ACETATE) TPN (TOTAL PARENTERAL NUTRITION) BAGS MADE IT DIFFICULT TO SPIKE COMPLETELY INTO THE PORT, LEADING TO 'NVN' LEAKS DUE TO INCOMPLETE INSERTION. THE LEAKS WERE OBSERVED 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 21057062 ↗
• MalfunctionJul 24, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN EXACTAMIX 5000 ML EVA TPN BAG LEAKED DURING COMPOUNDING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19817592 ↗
• MalfunctionJun 28, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT TEN (10) EXACTAMIX 5000 ML EVA (ETHYLENE VINYL ACETATE) TPN (TOTAL PARENTERAL NUTRITION) BAGS LEAKED FROM THE MIDDLE/ BROWN PORT PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19633129 ↗
• MalfunctionMar 25, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN EXACTAMIX 5000 ML EVA (ETHYLENE-VINYL ACETATE) TPN (TOTAL PARENTERAL NUTRITION) BAG LEAKED FROM "THE MIDDLE PORT ". THIS WAS OBSERVED AFTER THE BAG WAS FILLED WITH A DRUG. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18968242 ↗
• MalfunctionDec 8, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED A EXACTAMIX 5000 ML EVA TPN BAG LEAKED. THE LEAK ORIGINATED FROM THE MIDDLE PORT ¿INTO THE CAP AREA¿. THE LEAK WAS CONTAINED WITHIN THE CAP AND DID NOT HAVE EXPOSURE TO THE OUTSIDE ENVIRONMENT. THE LEAK WAS IDENTIFIED PRIOR TO LEAVING THE COMPOUNDING FACILITY. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18291319 ↗
• MalfunctionSep 7, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A 5000ML EVA (ETHYL VINYL ACETATE) TPN (TOTAL PARENTERAL NUTRITION) BAG WAS LEAKING FROM THE ADMINISTRATION PORT SEAM. THIS ISSUE WAS FURTHER DESCRIBED AS, ¿LEAK CAME FROM MIDDLE, ORANGE PORT SEAM¿. THE LEAK WAS IDENTIFIED DURING SETUP/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 17699713 ↗
• MalfunctionAug 24, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A 5000ML EVA (ETHYL VINYL ACETATE) TPN (TOTAL PARENTERAL NUTRITION) BAG LEAKED. THIS WAS IDENTIFIED DURING COMPOUNDING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17612652 ↗
• MalfunctionJul 26, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A 5000ML EVA (ETHYL VINYL ACETATE) TPN (TOTAL PARENTERAL NUTRITION) BAG WAS LEAKING FROM THE MIDDLE ORANGE PORT. THE LEAK WAS DISCOVERED DURING AN UNSPECIFIED PROCESS STEP. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17397149 ↗
• MalfunctionJul 6, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT TWO (2) 5000ML EVA (ETHYL VINYL ACETATE) TPN (TOTAL PARENTERAL NUTRITION) BAGS LEAKED OUT OF THE MIDDLE ORANGE PORT. THIS WAS IDENTIFIED DURING FILLING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17267472 ↗
• MalfunctionMar 23, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A 5000ML EVA (ETHYL VINYL ACETATE) TPN (TOTAL PARENTERAL NUTRITION) BAG LEAKED AT THE SPIKE PORT. THIS OCCURRED WHEN THE BAG WAS FILLED VIA THE ADD PORT WITH A NEEDLE. THE SPIKE PORT WAS NOT IN USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16600719 ↗
• MalfunctionMar 23, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A 5000ML EVA (ETHYL VINYL ACETATE) TPN (TOTAL PARENTERAL NUTRITION) WAS LEAKING FROM THE SPIKE PORT. THIS OCCURRED WHEN THE BAG WAS BEING FILLED VIA THE ADD PORT WITH A NEEDLE. THE SPIKE PORT WAS NOT IN USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16600575 ↗
• MalfunctionMar 13, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A 5000ML EVA (ETHYL VINYL ACETATE) TPN (TOTAL PARENTERAL NUTRITION) BAG LEAKED AT THE SPIKE PORT. THIS OCCURRED WHEN THE BAG WAS BEING FILLED VIA THE ADMINISTRATION PORT WITH A NEEDLE, THE SPIKE PORT WAS NOT IN USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16531028 ↗
• MalfunctionFeb 25, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A 5000ML EVA (ETHYL VINYL ACETATE) TPN (TOTAL PARENTERAL NUTRITION) BAG LEAKED FROM THE SPIKE PORT. THE ISSUE WAS IDENTIFIED DURING MEDIA FILL TESTING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13606990 ↗
• MalfunctionFeb 25, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A 5000ML EVA (ETHYL VINYL ACETATE) TPN (TOTAL PARENTERAL NUTRITION) BAG WAS LEAKING FROM THE SPIKE PORT. THE LEAK WAS DISCOVERED DURING MEDIA FILL TESTING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13604519 ↗
• MalfunctionFeb 25, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A 5000ML EVA (ETHYL VINYL ACETATE) TPN (TOTAL PARENTERAL NUTRITION) BAG WAS LEAKING FROM THE SPIKE PORT. THE LEAK WAS DISCOVERED DURING ¿MEDIA FILL QUALS¿. 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 13602681 ↗
• MalfunctionJan 10, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A 5000ML EVA (ETHYL VINYL ACETATE) TPN (TOTAL PARENTERAL NUTRITION) LEAKED BETWEEN WHERE THE GLUE IS BETWEEN THE BAG AND THE PORT. THIS WAS OBSERVED DURING PREPARATION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13212090 ↗
• MalfunctionNov 1, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A 5000ML EVA (ETHYL VINYL ACETATE) TPN (TOTAL PARENTERAL NUTRITION) BAG WAS LEAKING. THIS WAS FURTHER DESCRIBED AS ¿ONCE THE TECHNICIAN STARTED FILLING FROM THE BULK BAG INTO THE SMALLER IV (INTRAVENOUS) BAGS, THEY NOTICED THAT THE 5000ML EVA BAG WAS LEAKING IN THE AREA WHERE BAXTER HEALTHCARE NAME AND ADDRESS IS STAMPED ON THE BAG.¿ THIS WAS IDENTIFIED DURING FILLING PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12729678 ↗
• MalfunctionApr 14, 2021Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  IT WAS REPORTED 2 5000ML EVA (ETHYL VINYL ACETATE) TPN (TOTAL PARENTERAL NUTRITION) BAGS LEAKED. THE EVENT WAS FURTHER DESCRIBED AS THE "MIDDLE PORT FELL OUT AND ALL DRUG COMPONENTS LEAKED OUT ONTO" THE AIR FLOW HOOD. THE EVENT OCCURRED DURING PRODUCT PREPARATION; WHICH IS PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11668066 ↗
• MalfunctionMar 16, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A 5000ML EVA (ETHYL VINYL ACETATE) TPN (TOTAL PARENTERAL NUTRITION) BAG LEAKED FROM THE ADDITIVE PORT DURING FILLING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11494452 ↗
• MalfunctionMar 11, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A 5000ML EVA (ETHYL VINYL ACETATE) TPN (TOTAL PARENTERAL NUTRITION) BAG LEAKED FROM ADDITIVE PORT. THERE WERE NO SIGNS OF PHYSICAL DISTRESS TO THE PRODUCT OR SHIPPING MATERIALS. THIS WAS IDENTIFIED DURING FILLING OF THE BAG. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11466997 ↗
• MalfunctionMar 9, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A 5000ML EVA (ETHYL VINYL ACETATE) TPN (TOTAL PARENTERAL NUTRITION) BAG LEAKED FROM THE ADDITIVE PORT. THIS WAS IDENTIFIED DURING FILLING OF THE BAG, PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11449515 ↗
• MalfunctionFeb 1, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF 5000ML EVA (ETHYL VINYL ACETATE) TPN (TOTAL PARENTERAL NUTRITION) BAGS LEAKED WHERE THE BAGS WERE SEALED IN BETWEEN THE THREE PORTS. THE LEAKS WERE DISCOVERED DURING SETUP AND PREPARATION AFTER COMPOUNDING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 11261237 ↗
• MalfunctionFeb 1, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF 5000ML EVA (ETHYL VINYL ACETATE) TPN (TOTAL PARENTERAL NUTRITION) BAGS LEAKED WHERE THE BAGS WERE SEALED IN BETWEEN THE THREE PORTS. THE LEAKS WERE DISCOVERED DURING SETUP AND PREPARATION AFTER COMPOUNDING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 11261234 ↗
• MalfunctionDec 15, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A 5000ML EVA (ETHYL VINYL ACETATE) TPN (TOTAL PARENTERAL NUTRITION) BAG LEAKED FROM THE MIDDLE PORT (ALSO REPORTED AS "BETWEEN THE SPIKE PORT TUBE AND THE SPIKE PORT BONDING AREA"). THE LEAK WAS DISCOVERED DURING SETUP AND PREPARATION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 11006704 ↗
• MalfunctionNov 19, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT ONE (1) 5000 ML EVA (ETHYL VINYL ACETATE) TPN (TOTAL PARENTERAL NUTRITION) BAG WAS LEAKING FROM ¿WHERE THE MIDDLE PORT IS SEALED INTO THE BAG¿. THE LEAK WAS DISCOVERED DURING COMPOUNDING, PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 10870103 ↗

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. H9387
• 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-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-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-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-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-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-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-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-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-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.