EXACTAMIX H938905Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 00085412477473), received between Oct 29, 2018 and Aug 7, 2026 — classified as 31 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (19 reports).

9 other recalls cover devices cleared under the same FDA submission (K960581); 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 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 7, 2026Defective Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50175187 ↗
• MalfunctionAug 12, 2025Leak/Splash; Mechanical Problem; Leak/Splash; Mechanical Problem

  A CUSTOMER REPORTED THAT ONE PARENTERAL NUTRITION BAG WAS LEAKING DURING STORAGE AT THE PATIENT'S HOME PRIOR TO USE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION AS A RESULT OF THIS EVENT. NO PRODUCT SAMPLE OR PHOTOS OF THE SAMPLE ARE AVAILABLE FOR INVESTIGATION. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22788446 ↗
• MalfunctionJan 23, 2025Leak/Splash; Mechanical Problem; Leak/Splash; Mechanical Problem

  A CUSTOMER REPORTED, "1 COMPOUNDED PARENTERAL NUTRITION BAG WAS LEAKING. CUSTOMER REPORTED THE ORIGIN OF LEAK WAS A "SMALL SPLIT IN IT AT THE VERY TOP". THE TEAR WAS IN THE CENTRAL SECTION OF THE SMOF CHAMBER JUST ABOVE THE STICKER. THERE WAS NO TEAR NOTICED ON THE OUTER BAG. THIS WAS DISCOVERED WHEN THE NURSES WERE PREPARING IT THE PREVIOUS AFTERNOON. NO BATCH NUMBER WAS RECORDED AND THE BAG WAS NOT KEPT OR PHOTOGRAPHED." THE CUSTOMER CONFIRMED THERE WAS NO SKIN CONTACT WITH ANY SPILLED CONTENTS AND NO INJURY OR MEDICAL INTERVENTION AS A RESULT OF THIS EVENT. THE CUSTOMER STATED THAT THE OVERPOUCH AND EXTERNAL PACKAGING CARTON DID NOT APPEAR TO BE DAMAGED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21219289 ↗
• MalfunctionNov 20, 2024Fluid/Blood Leak; Leak/Splash; Mechanical Problem; Fluid/Blood Leak; Leak/Splash; Mechanical Problem

  CUSTOMER REPORTED ONE UNIT OF A COMPOUNDED PARENTERAL NUTRITION BAG WAS FOUND TO BE LEAKING AT A PATIENT'S HOME PRIOR TO USE. THE PATIENT REPORTED AS THEY WERE SETTING UP, THE PRODUCT WAS NOTICED TO BE LEAKING FROM THE TUBING AT THE BOTTOM OF THE BAG, WHICH IS WRAPPED IN A SILVER COVER. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION AS A RESULT OF THIS EVENT. THE ACTUAL SAMPLE WAS DISCARDED BY THE CUSTOMER; HOWEVER, PHOTOGRAPHS WERE PROVIDED FOR THE INVESTIGATION AND NO VISIBLE SIGNS OF LEAKAGE (HOLES, DROPLETS, OR WETNESS) WERE DETECTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20736791 ↗
• MalfunctionJun 20, 2024Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED THAT ONE SAMPLE OF TOTAL PARENTERAL NUTRITION (TPN) BAG PRODUCT 63630 WAS IDENTIFIED WITH A LEAK PRIOR TO USE BY THE END USER. THE CUSTOMER REPORTED THAT THE BAG LEAK WAS NOT CONTAINED TO THE OVERPOUCH AND BAG CONTENTS SPILLED ON TO A CONTACT SURFACE. THE PATIENT REPORTED SKIN CONTACT WITH THE SOLUTION. NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT WAS UNABLE TO DETERMINE THE SOURCE OF THE LEAK. NO PHOTOS, SAMPLE, OR LOT NUMBER OF THE IMPACTED SAMPLE WERE AVAILABLE FOR REVIEW. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19579492 ↗
• MalfunctionMay 21, 2024Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED THAT ONE SAMPLE OF TOTAL PARENTERAL NUTRITION (TPN) BAG PRODUCT 63630 WAS IDENTIFIED WITH A LEAK PRIOR TO USE BY THE END USER. THE CUSTOMER REPORTED THAT THE BAG WAS IDENTIFIED AS LEAKING WITHIN THE OVERPOUCH PACKAGING AND DISCARDED WITH NO SAMPLE EVALUATION OR IMAGES PROVIDED. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION AS A RESULT OF THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19365831 ↗
• MalfunctionFeb 16, 2024Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED 1 COMPOUNDED PARENTERAL NUTRITION BAG WAS LEAKING IDENTIFIED PRIOR TO THE USE OF THE PRODUCT. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS PROVIDED BY THE CUSTOMER THAT THE PRODUCT SAMPLE HAD BEEN DISCARDED AND THAT THE LEAK HAD NOT BEEN DISCOVERED UNTIL THE CUSTOMER HAD "OPENED EVERYTHING UP AS PER THE USUAL PROCEDURE". CONFIRMATION WAS RECEIVED THAT THERE WAS NO SKIN CONTACT OF BAG CONTENTS WITH THE END USER. IN RELATION TO THE LEAK LOCATION, THE CUSTOMER STATED IT APPEARED THE LEAK WAS COMING FROM THE SEAM OF THE PRODUCT. CUSTOMER CONFIRMED THERE WAS NO IDENTIFIABLE DAMAGE TO PRODUCT PACKAGING OR THE CARTON THE PRODUCT WAS RECEIVED IN. THE PRODUCT SAMPLE AND PHOTOS OF THE PRODUCT SAMPLE WERE NOT AVAILABLE FOR REVIEW. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18721566 ↗
• MalfunctionJan 15, 2024Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED 1 COMPOUNDED SOLUTION BAG WAS LEAKING AT THE PATIENT'S HOME PRIOR TO USE. CUSTOMER STATED " I AM NOT EXACTLY SURE WHERE IT IS COMING FROM AND IT IS NOT A BIG LEAK BUT IT SEEMS TO BE A SMALL DRIP FROM THE BOTTOM SOMEWHERE". THE PRODUCT SAMPLE WAS NOT AVAILABLE FOR EVALUATION. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION AS A RESULT OF THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18514362 ↗
• MalfunctionOct 24, 2023Fluid/Blood Leak; Leak/Splash; Mechanical Problem; Fluid/Blood Leak; Leak/Splash; Mechanical Problem

  CUSTOMER REPORTED THAT A PATIENT IDENTIFIED A LEAK IN ONE BAG AT THEIR HOME DURING THE PATIENT'S TPN INFUSION. CUSTOMER FURTHER RESPONDED THAT THE INFUSION HAD GONE SEVERAL HOURS WITHOUT ISSUE UNTIL THE PATIENT FELL ASLEEP DURING THE INFUSION AND WOKE UP WITH LEAKED TPN ON THE PATIENT AND SURROUNDING AREA. THERE WERE NO LEAKS APPARENT WHEN THE ROD WAS REMOVED PRIOR TO BEGINNING THE INFUSION. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION AS A RESULT OF THIS EVENT. THE SAMPLE WAS NOT RETURNED FOR EVALUATION. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17997015 ↗
• MalfunctionJun 23, 2023Fluid/Blood Leak; Fluid/Blood Leak

  UPDATE: IN THE ORIGINAL 1937141-2023-00018 SUBMISSION, THE BOX "CONGENITAL ANOMALY/BIRTH DEFECT" WAS INADVERTENTLY CHECKED. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS REPORT. ORIGINAL PROBLEM DESCRIPTION: RECEIVED REPORT OF LIPID MIGRATION IN DUAL CHAMBER BAG AFTER TRANSPORT TO LOCATION OF END USE. ISSUE WAS DISCOVERED DURING INSPECTION OF BAG PRIOR TO SETTING UP FOR ADMINISTRATION. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION AS A RESULT OF THIS EVENT. THE ACTUAL SAMPLES WERE DISCARDED BY THE CUSTOMER. NO PHOTOGRAPHS HAVE BEEN PROVIDED FOR INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17194901 ↗
• MalfunctionMar 30, 2023Fluid/Blood Leak; Fluid/Blood Leak

  CUSTOMER REPORTED THAT A PATIENT IDENTIFIED A LEAK IN TWO PARENTERAL NUTRITION BAGS AT THEIR HOME PRIOR TO USE . THE CUSTOMER FURTHER REPORTED "PATIENT REPORTED THEY NOTICED THAT 2 BAGS WERE LEAKING; HOWEVER COULD NOT IDENTIFY THE LOCATION OF THE LEAKS. PATIENT HAD ALREADY DISPOSED OF THE BAGS AND COULD NOT RETRIEVE THEM FOR A PHOTO." THE CUSTOMER WAS UNABLE TO OBTAIN INFORMATION FROM THE PATIENT REGARDING IF ANY SKIN CONTACT WITH THE SPILLED SOLUTION HAD OCCURRED NOR IF ANY DAMAGE WAS OBSERVED TO THE PRODUCT PACKAGING. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION AS A RESULT OF THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16644166 ↗
• MalfunctionMar 21, 2023Fluid/Blood Leak; Fluid/Blood Leak

  CUSTOMER REPORTED THAT A PATIENT IDENTIFIED A LEAK IN ONE TOTAL PARENTERAL NUTRITION BAG AT THEIR HOME PRIOR TO USE. THE CUSTOMER FURTHER REPORTED "PATIENT COULD NOT IDENTIFY WHERE THE LEAK WAS COMING FROM AND WAS NOT SURE IF THERE WAS ANY DAMAGE TO THE BAG OR CARTON." AS THE SAMPLE WAS DISCARDED AND NO PHOTOGRAPHS ARE AVAILABLE, COMPOUNDING BATCH DETAILS REMAIN UNKNOWN. THE CUSTOMER REPORTED "THE SPILL WAS CONTAINED IN THE OVERPOUCH, THERE WAS NO SKIN CONTACT WITH ANY SPILLED SOLUTION". THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION AS A RESULT OF THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16582123 ↗
• MalfunctionMar 17, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A 3000 ML DUAL-CHAMBER EVA (ETHYL VINYL ACETATE) BAG LEAKED FROM AN UNSPECIFIED LOCATION. THIS WAS IDENTIFIED BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16567906 ↗
• MalfunctionOct 31, 2022Fluid/Blood Leak; Fluid/Blood Leak

  CUSTOMER REPORTED ONE UNIT OF A COMPOUNDED PARENTERAL NUTRITION (PN) BAG THAT WAS FOUND TO BE LEAKING AT A PATIENT'S HOME PRIOR TO USE. THE PATIENT REPORTED "THE BAG I OPENED LAST NIGHT AND NOTICED SOME PN FLUID IN THE OVER POUCH WHEN I CUT IT OPEN- MAYBE AROUND 20 MLS? IT POURED OUT ONTO THE BENCH AFTER I CUT THE OVER POUCH OPEN. I CAN'T SEEM TO FIND AN OBVIOUS LEAK ON THE PN BAG BUT THE MIXING PORT IS SATURATED ALONG WITH THE OUTSIDE OF THE PN BAG. IMAGES ARE OF THE NEXT MORNING SO UNABLE TO PROVIDE PICTURES OF THE FLUID SPILL AS THIS WAS CLEANED UP." THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION AS A RESULT OF THIS EVENT. THE PATIENT CONFIRMED THERE WAS SKIN CONTACT WITH THE SPILLED PN SOLUTION. CUSTOMER CONFIRMED THEY IMMEDIATELY WASHED THEIR HANDS WITH SOAP AND WATER. THE CUSTOMER STATED THEY DID NOT OBSERVE ANY DAMAGE TO THE PRODUCT OVERPOUCH, DELIVERY BOX OR OTHER ITEMS WITHIN THE BOX. THE CUSTOMER STATED "WAS ONLY A LITTLE FLUID THAT HAD LEAKED ONTO THE OUTSIDE OF ANOTHER BAG, BUT THIS WAS A VERY SMALL AMOUNT (MAINLY DROPLETS) AND I WIPED IT CLEAN WITH A LARGE ALCOHOL WIPE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15698405 ↗
• MalfunctionOct 21, 2022Premature Activation; Premature Activation

  IT WAS REPORTED THAT "THEY ARE HAVING ISSUES WITH A PATIENT'S DUAL CHAMBER BAG IN SHIPMENT. LOOKS LIKE MIDDLE IS ACTIVATING SOMEHOW. JUST STARTED. IT WAS FINE AND NOW IT ISN'T. SAME PERSON IS PACKING. PHOTO SAMPLE IS NOT AVAILABLE. THE EVENT OCCURRED WAS NOT SPECIFIED. THE OCCURRENCE OF THE EVENT WAS BEFORE USE. NO PATIENT INVOLVEMENT." THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION AS A RESULT OF THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15650319 ↗
• MalfunctionSep 7, 2022Fluid/Blood Leak; Fluid/Blood Leak

  CUSTOMER ADVISED THE PARENTS OF A HOME PATIENT REPORTED ONE COMPOUNDED PARENTERAL NUTRITION BAG LEAKING APPROXIMATELY 2 HOURS INTO THE INFUSION. THE END USER REPORTED THE BAG LEAKED ON THE SIDE WHERE THE TWO EDGES OF THE BAG JOIN. THE PATIENT WAS AT HOME IN BED DURING THE INFUSION AND THERE WAS NO SKIN CONTACT WITH THE PARENTERAL NUTRITION SOLUTION. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION AS A RESULT OF THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15374403 ↗
• MalfunctionDec 28, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT ONE UNIT OF AN EXACTAMIX DUAL CHAMBER BAG WAS FOUND TO BE LEAKING DURING THE FILLING PROCESS AT THE PHARMACY. THE CUSTOMER STATED THAT WHEN THE ASSISTANT INFUSED LIPIDS INTO THE SMALL CHAMBER OF THE BAG, THEY NOTICED A TEAR WHICH BEGAN TO LEAK. THE CUSTOMER STATED THE TEAR WAS UNDER WHERE THE CHAMBERS WERE SEPARATED. THE LEAK WAS IDENTIFIED PRIOR TO PATIENT USE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION AS A RESULT OF THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13095084 ↗
• MalfunctionDec 1, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT TWO UNITS OF AN EXACTAMIX DUAL CHAMBER BAG WERE FOUND TO BE LEAKING. THE LEAK WAS IDENTIFIED PRIOR TO REMOVAL OF THE ROD AND CHANNEL SEPARATING THE CHAMBERS. THE LEAK WAS IDENTIFIED PRIOR TO PATIENT USE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION AS A RESULT OF THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12908360 ↗
• MalfunctionOct 20, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A SINGLE UNIT OF AN EXACTAMIX DUAL CHAMBER BAG WAS FOUND TO BE LEAKING JUST ABOVE THE SPIKING AREA. THE LEAK WAS IDENTIFIED AT THE HOSPITAL PRIOR TO PATIENT USE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION AS A RESULT OF THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12666957 ↗
• MalfunctionSep 16, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A SINGLE UNIT OF AN EXACTAMIX DUAL CHAMBER BAG WAS FOUND TO BE LEAKING VIA A TEAR. THE LEAK WAS IDENTIFIED PRIOR TO USE AT A PATIENT'S HOME. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION AS A RESULT OF THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 12485049 ↗
• MalfunctionJul 15, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A SINGLE UNIT OF AN EXACTAMIX 3000 ML DUAL CHAMBER EVA BAG WAS FOUND TO BE LEAKING DURING ADMINISTRATION AT THE PATIENT'S HOME. IT WAS REPORTED THAT THE OUTSIDE OF THE BLADDER BAG WAS WET WITH A WHITE LIQUID AND UPON CLOSER INSPECTION A TINY HOLE WAS NOTED UNDERNEATH THE PN NUTRIENT LABEL. THE LEAK WAS IDENTIFIED AFTER 170 ML OF THE SOLUTION HAD BEEN ADMINISTERED. ADMINISTRATION WAS THEN CEASED. IT WAS REPORTED THAT THE PATIENT HAS BEEN MONITORED BY MOM AND NO ADVERSE EFFECT WAS NOTICED. IT WAS ALSO REPORTED THAT THERE WAS NO SKIN CONTACT WITH THE SPILLED PN SOLUTION. THE ACTUAL SAMPLE WAS DISCARDED BY THE CUSTOMER AND NO PHOTOGRAPHS ARE AVAILABLE. IT WAS REPORTED THAT THE SILVER OVERPOUCH AND LABEL WERE NOT DAMAGED. THE CUSTOMER CONFIRMED THEY USED THEIR USUAL METHOD OF OPENING THE BAG OVERPOUCH, CAREFULLY USING SCISSORS. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12174149 ↗
• MalfunctionJun 15, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A SINGLE UNIT OF AN EXACTAMIX 3000 ML DUAL CHAMBER EVA BAG WAS FOUND TO BE LEAKING UPON ARRIVAL AT A PATIENT'S HOME. THE LEAK WAS IDENTIFIED PRIOR TO USE AND THE ACTUAL SAMPLE WAS DISCARDED BY THE CUSTOMER. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION AS A RESULT OF THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11998708 ↗
• MalfunctionJun 11, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PATIENT'S MOTHER CALLED THE HOSPITAL TO REPORT THAT PARENTERAL NUTRITION SOLUTION WAS LEAKING BETWEEN THE CHAMBERS OF AN EXACTAMIX 3000 ML DUAL CHAMBER EVA BAG. THIS WAS IDENTIFIED AT THE PATIENT'S HOME PRIOR TO USE. IT WAS FURTHER REPORTED THAT THE PATIENT NOTICED THE LEAK BEFORE ACTIVATING THE DUAL CHAMBER BAG AND THAT THE LIPID FROM THE TOP CHAMBER WAS LEAKING INTO THE BOTTOM CHAMBER. IT IS UNCLEAR IF THE BAG WAS PARTIALLY ACTIVATED ALREADY, OR IF THERE WAS AN ISSUE WITH THE SEAL BETWEEN THE TWO CHAMBERS. AS THE LEAK WAS BETWEEN THE CHAMBERS, NO PARENTERAL NUTRITION SOLUTION SPILLED FROM THE BAG TO THE OUTSIDE ENVIRONMENT. THERE WAS NO MENTION OF THE CONDITION OF THE DIVIDING ROD OR WHETHER IT WAS PLACED CORRECTLY. AFTER NOTICING THE LEAK, THE PATIENT ACTIVATED THE BAG AND THEN DISCARDED IT. NO PHOTOGRAPHS HAVE BEEN PROVIDED. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION AS A RESULT OF THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11982825 ↗
• MalfunctionMay 28, 2021Pumping Problem; Pumping Problem

  IT WAS REPORTED THAT ONE UNIT OF BODYGUARD 323 COLOUR VISION PD WAS OBSERVED TO HAVE UNDERINFUSED TPN CONTAINED WITHIN AN EXACTAMIX 3000ML DUAL CHAMBER EVA BAG. IT WAS FURTHER REPORTED THAT THE PATIENT PUMP WAS PROGRAMMED TO DELIVER 2345 ML OVER 14 HOURS WITH 1 HOUR UP TIME AND 1 HOUR DOWN TIME. THE TOTAL BAG VOLUME WAS STATED AS 2530 ML. AT THE END OF INFUSION PATIENT TPN BAG HAD AN OBSERVED OVERAGE APPROXIMATELY 800 ML AS OPPOSED TO THE EXPECTED 200 ML. IT WAS REPORTED THAT THE PATIENT'S FATHER MENTIONED THAT THE PUMP DID ALARM WITH UP/AIR OCCLUSION AT APPROXIMATELY 12 AM WHEN THEY REMOVED THE LINE TO RECTIFY THE AIR IN LINE ALARM, THEY NOTICED THAT THE LINE HAD A KINK WHERE THE PUMPING MECHANISM SEGMENT WAS LOCATED. WHEN THE LINE WAS REINSERTED THE PUMP CONTINUED TO FUNCTION WITH ONLY ONE SUBSEQUENT ALARM AT 2:45 AM. THIS ALARM WAS ALSO RECTIFIED AND THE PUMP CONTINUED UNINTERRUPTED UNTIL THE END OF INFUSION. IT WAS REPORTED THAT A PUMP SWAP OUT WAS REQUIRED. THERE WAS PATIENT INVOLVEMENT AS THIS WAS NOTICED DURING PATIENT INFUSION BUT THERE WAS NO HARM NOTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 11901877 ↗
• MalfunctionSep 21, 2020Break; Difficult to Open or Close; Break; Difficult to Open or Close

  IT WAS REPORTED THAT THERE WAS DIFFICULTY IN CLOSING THE CLAMPS OF AN UNSPECIFIED QUANTITY OF EXACTAMIX 3000 ML DUA L-CHAMBER EVA BAGS. IT WAS FURTHER REPORTED THAT WHEN CLOSING THE CLAMPS, PIECES OF PLASTIC BREAK OFF INSIDE THE HOOD. THIS ISSUE WAS IDENTIFIED DURING SETUP PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 10563379 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K960581. One submission often covers many models, so check the product and lot details in each record.

• Z-0002-2020 · Sep 21, 2018 · Open, Classified
  SECURE EVA - DUAL CHAMBER CONTAINER With Screw Connectors, 3000mL, (legless) REF 66630 - Product Usage: For use in an intravenous admixture program. The empty container will be fil
• Z-0001-2020 · Sep 21, 2018 · Open, Classified
  SECURE EVA - DUAL CHAMBER CONTAINER With Screw Connectors, 1500mL, (legless) REF 66615 - Product Usage: For use in an intravenous admixture program. The empty container will be fil
• Z-0005-2020 · Sep 21, 2018 · Open, Classified
  SECURE EVA - DUAL CHAMBER CONTAINER with Manifold, 3000mL, REF 66631 (Canadian distribution) - Product Usage: For use in an intravenous admixture program. The empty container will
• Z-0003-2020 · Sep 21, 2018 · Open, Classified
  SECURE EVA - DUAL CHAMBER CONTAINER With Screw Connectors, 4000mL, (legless) REF 66640 - Product Usage: For use in an intravenous admixture program. The empty container will be fil
• Z-0004-2020 · Sep 21, 2018 · Open, Classified
  SECURE EVA - DUAL CHAMBER CONTAINER with Manifold, 1500mL, REF 66616 (Canadian distribution) - Product Usage: For use in an intravenous admixture program. The empty container will
• Z-0007-2020 · Sep 21, 2018 · Open, Classified
  ExactaMix, Model: H938901, EMPTY EVA DUAL CHAMBER CONTAINER With Screw Connectors, 500 ml/ 2500 ml, Baxter - Product Usage: For use in an intravenous admixture program. The empty
• Z-0006-2020 · Sep 21, 2018 · Open, Classified
  SECURE EVA - DUAL CHAMBER CONTAINER with Manifold, 4000mL, REF 66641 (Canadian distribution) - Product Usage: For use in an intravenous admixture program. The empty container will
• Z-0008-2020 · Sep 21, 2018 · Open, Classified
  ExactaMix, Model: H938905, EMPTY EVA DUAL CHAMBER CONTAINER With Screw Connectors, 250 ml/ 1250 ml, Baxter - Product Usage: For use in an intravenous admixture program. The empty
• Z-2263-2016 · Jun 23, 2016 · Terminated
  Dual Chamber Container fill with gravity/attached transfer sets, 250 mL / 1250 mL, 300 mL / 1700 mL, 500 mL / 2500 mL, 500 mL / 3500 mL