MaxGuard ME1247Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10885403274305), received between Jun 4, 2020 and Dec 23, 2020 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 23, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE 7-IN STD BORE BI-FURCATED EXT SET EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: ME1247, BATCH NO: UNKNOWN. PRODUCT LEAKING AT Y- SITE CONNECTION WHILE INFUSING CYTOTOXIC MEDICATION. REPLACING SPLITTER RESOLVED THE PROBLEM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11068734 ↗
• MalfunctionJun 22, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE 7-IN STD BORE BI-FURCATED EXT SET LEAKED DURING A CHEMOTHERAPY CYCLOPHOSPHAMIDE INFUSION. ABSORBENT PADS WERE PLACED UNDER THE EXTENSION SET, AND THE TREATMENT WAS DELAYED FOR "ABOUT TWENTY MINUTES" AS A RESULT, BUT THERE WAS NO IMPACT TO THE PATIENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT A SMALL AMOUNT OF LEAKAGE WAS SEEN AT THE ENGAGEMENT OF BIFUSE EXTENSION SET DURING AN INFUSION OF CHEMOTHERAPY CYCLOPHOSPHAMIDE THROUGH SECONDARY SET. THE MEDICATION WAS BEING ADMINISTERED USING A NON-BD INFUSION PUMP. IT WAS NOTED THAT THE RN HAD TO PUT ABSORBENT PADS UNDERNEATH THE EXTENSION SET DUE TO THE CLINICIAN¿S PREVIOUS EXPERIENCE OF LEAKS REGARDING THE SAME TUBING. THE CERTIFIED NURSE EDUCATOR (CNE) ATTEMPTED TO REPLICATE THE LEAK, BUT UNABLE TO DO SO AND INSTEAD, RECOMMENDED THAT IN FUTURE, TO USE THE SETS WITH CAUTION AND TO HAVE AN ABSORBENT PAD UNDERNEATH, IN CASE OF LEAKS. THE TREATMENT WAS DELAYED FOR ABOUT TWENTY MINUTES TO ALLOW FOR EVENT REPORTING TO CNE, DOCUMENTATION, AND REPLACEMENT OF THE TUBING. THERE WAS NO PATIENT IMPACT. THE EVENT OCCURRED AT THE ONCOLOGY UNIT."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10179644 ↗
• MalfunctionJun 4, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THAT A SMALL AMOUNT OF LEAKAGE WAS SEEN AT THE ENGAGEMENT OF BIFUSE EXTENSION SET DURING AN INFUSION OF CHEMOTHERAPY CYCLOPHOSPHAMIDE THROUGH SECONDARY SET. THE MEDICATION WAS BEING ADMINISTERED USING A NON-BD INFUSION PUMP. IT WAS NOTED THAT THE RN HAD TO PUT ABSORBENT PADS UNDERNEATH THE EXTENSION SET DUE TO THE CLINICIAN¿S PREVIOUS EXPERIENCE OF LEAKS REGARDING THE SAME TUBING. THE CERTIFIED NURSE EDUCATOR (CNE) ATTEMPTED TO REPLICATE THE LEAK, BUT UNABLE TO DO SO AND INSTEAD, RECOMMENDED THAT IN FUTURE, TO USE THE SETS WITH CAUTION AND TO HAVE AN ABSORBENT PAD UNDERNEATH, IN CASE OF LEAKS. THE TREATMENT WAS DELAYED FOR ABOUT TWENTY MINUTES TO ALLOW FOR EVENT REPORTING TO CNE, DOCUMENTATION, AND REPLACEMENT OF THE TUBING. THERE WAS NO PATIENT IMPACT. THE EVENT OCCURRED AT THE ONCOLOGY UNIT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10120750 ↗