MaxGuard ME2064Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10885403236280), received between Jul 12, 2019 and Apr 7, 2020 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Break” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 7, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED AN UNSPECIFIED TUBING ISSUE THAT IS POSSIBLY RELATED TO THE PREVIOUS EVENTS OF LEAKS, CRACKS OR CRUMBLING OF THE FIXED COLLAR ON THE DISTAL END OF EXTENSION SET ME2017. THE TUBING WAS RECEIVED WITH A LABEL "AMIO" WRITTEN ON IT. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION WAS NOT PROVIDED.

  Patient problems: No Information

  MAUDE report 9932861 ↗
• MalfunctionJul 12, 2019Break; No Flow; Break; No Flow

  IT WAS REPORTED THAT THE NURSE HAD TO CHANGE OUT THE NEWER EXTENSION SET WITH THE 0.2MICRON FILTER 3 SEPARATE TIMES DUE TO THE DEVICE ALARMING "PATIENT SIDE OCCLUSION". THE NURSE CHECKED THE PATIENT'S IV SITE FOR PATENCY WHICH HAD GOOD BLOOD RETURN. THE NURSE EVENTUALLY SWITCHED TO ONE OF THE PREVIOUSLY USED EXTENSION SET MATERIAL NUMBERS AND ADDED A FILTER TO HAVE THE INFUSION COMPLETE WITHOUT FURTHER COMPLICATIONS. THE NURSE NOTED THAT THE PREVIOUS EXTENSION SET THAT THEY USED WAS 2ML, WHEREAS THIS EXTENSION SET IS FOR ONLY 0.6ML. IT IS ALSO NOTED ON THE ATTACHED PICTURE THAT THE MALE LUER APPEARS TO BE BROKEN OR INAPPROPRIATELY SEPARATED. IT IS NOTED THAT THE PRODUCT HAS A SPIN COLLAR MALE LUER.

  Patient problems: No Information

  MAUDE report 8787046 ↗
• MalfunctionJul 12, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE TUBING SET LEAKED AROUND THE FILTER AFTER A PRN MEDICATION WAS ADMINISTERED VIA THE MEDICATION LINE LOCATED IN THE PATIENT'S LEFT LEG.

  Patient problems: No Information

  MAUDE report 8787045 ↗
• MalfunctionJul 12, 2019Break; No Flow; Break; No Flow

  IT WAS REPORTED THAT THE NURSE HAD TO CHANGE OUT THE NEWER EXTENSION SET WITH THE 0.2MICRON FILTER 3 SEPARATE TIMES DUE TO THE DEVICE ALARMING "PATIENT SIDE OCCLUSION". THE NURSE CHECKED THE PATIENT'S IV SITE FOR PATENCY WHICH HAD GOOD BLOOD RETURN. THE NURSE EVENTUALLY SWITCHED TO ONE OF THE PREVIOUSLY USED EXTENSION SET MATERIAL NUMBERS AND ADDED A FILTER TO HAVE THE INFUSION COMPLETE WITHOUT FURTHER COMPLICATIONS. THE NURSE NOTED THAT THE PREVIOUS EXTENSION SET THAT THEY USED WAS 2ML, WHEREAS THIS EXTENSION SET IS FOR ONLY 0.6ML. IT IS ALSO NOTED ON THE ATTACHED PICTURE THAT THE MALE LUER APPEARS TO BE BROKEN OR INAPPROPRIATELY SEPARATED. IT IS NOTED THAT THE PRODUCT HAS A SPIN COLLAR MALE LUER.

  Patient problems: No Information

  MAUDE report 8787044 ↗
• MalfunctionJul 12, 2019Break; Break

  IT WAS REPORTED THAT THE TUBING SET "BROKE" WHILE IN USE ON AN INFANT PATIENT. PER THE CUSTOMER, THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Information

  MAUDE report 8787043 ↗
• MalfunctionJul 12, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE TUBING SET FILTER LEAKED INTO THE INFANT PATIENT'S BED AFTER MULTIPLE MEDICATIONS WERE ADMINISTERED VIA THE PATIENT'S BROVIAC CENTRAL LINE LOCATED IN THE PATIENT'S LEFT FEMORAL.

  Patient problems: No Information

  MAUDE report 8786993 ↗
• MalfunctionJul 12, 2019Backflow; Fluid/Blood Leak; Backflow; Fluid/Blood Leak

  IT WAS REPORTED THAT THE RN ADMINISTERED MULTIPLE MEDICATIONS AT APPROXIMATELY 8:00 PM VIA THE INFANT PATIENTS BROVIAC CENTRAL LINE LOCATED IN THE PATIENT'S LEFT FEMORAL ARTERY. SHORTLY AFTER, THE PATIENT'S FATHER REPORTED THAT THE PATIENTS BED WAS SET. UPON ASSESSMENT, THE RN FOUND THAT THE PATIENT'S BLOOD BACKED UP INTO THE TUBING THAT HAD SEPARATED AND LEAKED FROM THE PRESSURE SENSING DISC.

  Patient problems: No Information

  MAUDE report 8786949 ↗
• MalfunctionJul 12, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT WHILE THE RN WAS ADMINISTERING PHENOBARBITAL AND ATIVAN WITH A 10CC SYRINGE, THE RN NOTICED A SMALL WET SPOT ON THE PATIENT'S BED. THE RN MADE A10CC SALINE FLUSH AND WHILE ADMINISTERING THE FLUSH OBSERVED THE SALINE LEAKING FROM THE TUBING SET FILTER. THE TUBING SET WAS REPLACED AND THE RN REPORTED THAT SHE WAS UNSURE AS TO HOW MUCH PHENOBARBITAL OR ATIVAN WAS ADMINISTERED TO THE INFANT PATIENT AND WOULD MONITOR THE PATIENT FOR POSSIBLE INCREASED AGITATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8786901 ↗
• MalfunctionJul 12, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE NURSE ADMINISTERED THE 0900 UNSPECIFIED MEDICATION WHILE USING A 1ML SYRINGE VIA THE PATIENT'S CENTRAL LINE LOCATED IN THE PATIENT'S RIGHT FEMORAL ARTERY. ONCE THE MEDICATION WAS ADMINISTERED, THE NURSE FLUSHED THE LINE WITH NORMAL SALINE WHILE USING A 5ML SYRINGE. AT APPROXIMATELY 10:50AM, THE INFANT PATIENT'S MOTHER CALLED THE NURSE INTO THE PATIENT'S ROOM STATING THAT THERE WAS BLOOD BACKING UP INTO THE PATIENT'S LINE. THE NURSE FLUSHED THE LINE WITH NORMAL SALINE 2ML WHILE USING A 10ML SYRINGE WHEN IT WAS NOTICED THAT THE TUBING SET FILTER LEAKED. THE TUBING SET WAS REPLACED. IT WAS FURTHER REPORTED THAT THERE WERE NO ADVERSE EFFECTS CAUSED TO THE INFANT FROM THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8786897 ↗
• MalfunctionJul 12, 2019Break; No Flow; Break; No Flow

  IT WAS REPORTED THAT THE NURSE HAD TO CHANGE OUT THE NEWER EXTENSION SET WITH THE 0.2MICRON FILTER 3 SEPARATE TIMES DUE TO THE DEVICE ALARMING "PATIENT SIDE OCCLUSION". THE NURSE CHECKED THE PATIENT'S IV SITE FOR PATENCY WHICH HAD GOOD BLOOD RETURN. THE NURSE EVENTUALLY SWITCHED TO ONE OF THE PREVIOUSLY USED EXTENSION SET MATERIAL NUMBERS AND ADDED A FILTER TO HAVE THE INFUSION COMPLETE WITHOUT FURTHER COMPLICATIONS. THE NURSE NOTED THAT THE PREVIOUS EXTENSION SET THAT THEY USED WAS 2ML, WHEREAS THIS EXTENSION SET IS FOR ONLY 0.6ML. IT IS ALSO NOTED ON THE ATTACHED PICTURE THAT THE MALE LUER APPEARS TO BE BROKEN OR INAPPROPRIATELY SEPARATED. IT IS NOTED THAT THE PRODUCT HAS A SPIN COLLAR MALE LUER.

  Patient problems: No Information

  MAUDE report 8786779 ↗
• MalfunctionJul 12, 2019Inaccurate Flow Rate; Improper Flow or Infusion; Infusion or Flow Problem; Inaccurate Flow Rate; Improper Flow or Infusion; Infusion or Flow Problem

  IT WAS REPORTED THAT THE HYDROCORTISONE INFUSION WAS INFUSING INTERMITTENTLY VIA THE INFANT PATIENT'S BROVIAC CENTRAL LINE LOCATED IN THE PATIENTS LEFT FEMORAL ARTERY.

  Patient problems: No Information

  MAUDE report 8786708 ↗
• MalfunctionJul 12, 2019Improper Flow or Infusion; Infusion or Flow Problem; Improper Flow or Infusion; Infusion or Flow Problem

  IT WAS REPORTED THAT THE UNSPECIFIED MEDICATION INFUSION WAS INFUSING INTERMITTENTLY VIA THE INFANT PATIENT'S RIGHT FEMORAL CENTRAL VENOUS LINE.

  Patient problems: No Consequences Or Impact To Patient; No Information

  MAUDE report 8786707 ↗
• MalfunctionJul 12, 2019Break; Break

  IT WAS REPORTED THAT THE INFANT PATIENT HAD A DOUBLE LUMEN PICC LINE THAT WAS LOCATED IN THE LEFT FEMORAL ARTERY. THE PICC'S FIRST LUMEN HAD THE FOLLOWING INFUSIONS; MILRINONE INFUSING AT A RATE OF 1.8ML/HOUR, DOPAMINE AT A RATE OF 2ML/HOUR, VERSED AT A RATE OF 0.4ML/HOUR, MORPHINE AT A RATE OF 0.5ML/HOUR AND CIS AT A RATE OF 1.4ML/HOUR INFUSING. THE SECOND PICC LINE LUMEN HAD AN EXTENSION TUBING SET ATTACHED TO A HEPARIN LOCKED BI-FUSE TUBING SET. THIS MEDICATION LINE WAS USED TO ADMINISTER THE SCHEDULED 8:00 PM MEDICATIONS OF LASIX AND PHENOBARBITAL WHEN THE FILTER BROKE.

  Patient problems: No Information

  MAUDE report 8786633 ↗