MaxZero MZ9325Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10885403427244), received between Jan 10, 2019 and Dec 3, 2025 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Obstruction of Flow” (5 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. 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 3, 2025Failure to Infuse; Failure to Infuse

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23710758 ↗
• MalfunctionDec 3, 2025Failure to Infuse; Failure to Infuse

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23710750 ↗
• MalfunctionApr 28, 2025Crack; Crack

  IT WAS REPORTED THAT BD EXTENSION SET BROKE THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT THE SPIN COLLAR CRACKED OFF HUB OF EXTENSION SET WHEN NURSE CHECKED INFUSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21918527 ↗
• MalfunctionMar 23, 2020Fluid/Blood Leak; Fluid/Blood Leak

  CUSTOMER ADVOCACY RECEIVED A COPY OF THE CUSTOMER'S MEDWATCH REPORT FROM THE FDA WHICH STATES, "CAREFUSION MICROBORE TRI-FUSE EXTENSION SET WITH FILTER NOTED TO BE LEAKING." AN INCOMPLETE DATE OF EVENT OF (B)(6) 2019 WAS PROVIDED.

  Patient problems: No Information

  MAUDE report 9868131 ↗
• MalfunctionJan 21, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING AN INFUSION IN THE SPECIALTY CARE NURSERY; A NEW TRIFUSE WAS SET UP AT 2200 AND A LEAK WAS IDENTIFIED IN THE ISOLETTE AT 0445. THE NURSE FLUSHED THE TRIFUSE WITH A NORMAL SALINE SYRINGE TO FIND A HOLE IN THE LIPID FILTER WHILE ADMINISTERING A TPN/LIPIDS 20% INFUSION WITH VTBI OF 8ML FOR A DURATION OF 6HR. THE TRIFUSE WAS ATTACHED TO A PREMATURE INFANT, BIRTH WEIGHT 12500-1499 GRAMS, WITH 32 COMPLETED WEEKS OF GESTATION. THIS WAS DISCOVERED AFTER NOTICING THE BED UNDER THE INFANT WAS WET. THE INFANT WAS NOT RECEIVING LIPIDS AS INTENDED, THEREFORE; THE TRIFUSE WAS REMOVED AND A NEW TRIFUSE PLACED. ALTHOUGH IT WAS NOTED THAT THERE WAS A DELAY IN TREATMENT, IT WAS ALSO CONFIRMED DURING FOLLOW UP, THAT THERE WAS NO PATIENT HARM OR IMPACT AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9613352 ↗
• MalfunctionOct 24, 2019Obstruction of Flow; Obstruction of Flow

  THE CUSTOMER REPORTED THAT THE MAXZERO TRI-FUSE TUBING SET OCCLUDES DURING A LIPID INFUSION WHILE IN USE IN THE SPECIAL CARE NURSERY. THE RN HAS TO "BREAK THE LINE" IN ORDER TO CONTINUE THE INFUSION. THE CUSTOMER FURTHER STATED THAT THERE WERE NO ADVERSE EFFECTS CAUSED TO THE PATIENT FROM THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9234811 ↗
• MalfunctionOct 24, 2019Obstruction of Flow; Obstruction of Flow

  THE CUSTOMER REPORTED THAT THE MAXZERO TRI-FUSE TUBING SET OCCLUDES DURING A LIPID INFUSION WHILE IN USE IN THE SPECIAL CARE NURSERY. THE NURSE DESCRIBES THE TUBING SET-UP AS FOLLOWS; THE BD ALARIS PUMP INFUSION BURETTE SET, ATTACH A MAXZERO TO THE TUBING SET, SPIKE THE FLUID WITH IV TUBING SET, PRIME TUBING WITH FLUIDS THOUGH MAXZERO, PRIME LIPID PORT WITH LIPIDS, PRIME MEDICATION PORT WITH NORMAL SALINE, PLACE THE TUBING SET INTO THE ALARIS PUMP AND CONNECT TO THE PATIENT'S CENTRAL LINE. WHEN THE TUBING SET OCCLUDES, THE RN HAS TO "BREAK THE LINE" IN ORDER TO CONTINUE THE INFUSION, WHICH THE CUSTOMER FURTHER STATED THAT THIS INCREASES THE RISK FOR INFECTION TO THE INFANT PATIENT. THE CUSTOMER FURTHER STATED THAT THERE WERE NO ADVERSE EFFECTS CAUSED TO THE INFANT PATIENT FROM THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9234809 ↗
• MalfunctionOct 24, 2019Obstruction of Flow; Obstruction of Flow

  THE CUSTOMER REPORTED THAT THE MAXZERO TRI-FUSE TUBING SET OCCLUDES DURING A LIPID INFUSION WHILE IN USE IN THE SPECIAL CARE NURSERY. THE RN HAS TO "BREAK THE LINE" IN ORDER TO CONTINUE THE INFUSION. THE CUSTOMER FURTHER STATED THAT THERE WERE NO ADVERSE EFFECTS CAUSED TO THE PATIENT FROM THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9234748 ↗
• MalfunctionOct 24, 2019Obstruction of Flow; Obstruction of Flow

  THE CUSTOMER REPORTED THAT THE MAXZERO TRI-FUSE TUBING SET OCCLUDES DURING A LIPID INFUSION WHILE IN USE IN THE SPECIAL CARE NURSERY. THE RN HAS TO "BREAK THE LINE" IN ORDER TO CONTINUE THE INFUSION. THE CUSTOMER FURTHER STATED THAT THERE WERE NO ADVERSE EFFECTS CAUSED TO THE PATIENT FROM THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9234745 ↗
• MalfunctionOct 24, 2019Obstruction of Flow; Obstruction of Flow

  THE CUSTOMER REPORTED THAT THE MAXZERO TRI-FUSE TUBING SET OCCLUDES DURING A LIPID INFUSION WHILE IN USE IN THE SPECIAL CARE NURSERY. THE RN HAS TO "BREAK THE LINE" IN ORDER TO CONTINUE THE INFUSION. THE CUSTOMER FURTHER STATED THAT THERE WERE NO ADVERSE EFFECTS CAUSED TO THE PATIENT FROM THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9234641 ↗
• MalfunctionJan 10, 2019Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE USER NOTED THAT THE BABY'S BLANKET WAS DAMP. THE RN PLACED A GAUZE UNDERNEATH THE UVC (PATIENT UMBILICAL VENOUS CATHETER) TRI-PORT AND FOUND IT TO BE LEAKING. UPON CLOSER OBSERVATION, THE "LIPID LINE" EXTENSION SET WAS NOTED TO BE CRACKED AND LEAKING AT THE BASE OF THE FILTER. THE USER HAD TO DISCONTINUED THE LIPID INFUSION AND CHANGED OUT THE LINES. THE EVENT OCCURRED IN THE NICU.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8236198 ↗