SafeDAY™ 352904Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 04046964181993), received between Dec 2, 2016 and Feb 11, 2021 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (9 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 11, 2021Infusion or Flow Problem; Infusion or Flow Problem

  EVENT 2: AS REPORTED BY THE USER FACILITY: A SET WAS LEAKING WHILE THE ROLLER CLAMP AND SLIDE CLAMP ABOVE THE FILTER WERE CLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11314311 ↗
• MalfunctionFeb 11, 2021Infusion or Flow Problem; Infusion or Flow Problem

  EVENT 1: AS REPORTED BY THE USER FACILITY: A SET WAS LEAKING WHILE THE ROLLER CLAMP AND SLIDE CLAMP ABOVE THE FILTER WERE CLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11314307 ↗
• MalfunctionDec 16, 2020Free or Unrestricted Flow; Infusion or Flow Problem; Free or Unrestricted Flow; Infusion or Flow Problem

  EVENT 3: AS REPORTED BY THE USER FACILITY: "WE HAVE NOTICED THAT THE FILTERED TUBING WE HAVE BEEN USING IS LEAKING AT THE END PORT BETWEEN TWO OF THE PLASTIC PIECES. THIS IS HAPPENING EVEN WHEN THE ROLLER CLAMP AND THE SLIDE CLAMP ARE CLOSED. EVEN WHEN BOTH CLAMPS ARE CLOSED, THE TUBING STILL LEAKS, AND IF THE END OF THE TUBING IS RAISED ABOVE THE BAG, AIR FLOWS INTO THE END OF THE TUBING."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11021289 ↗
• MalfunctionDec 16, 2020Free or Unrestricted Flow; Infusion or Flow Problem; Free or Unrestricted Flow; Infusion or Flow Problem

  EVENT 2: AS REPORTED BY THE USER FACILITY: "WE HAVE NOTICED THAT THE FILTERED TUBING WE HAVE BEEN USING IS LEAKING AT THE END PORT BETWEEN TWO OF THE PLASTIC PIECES. THIS IS HAPPENING EVEN WHEN THE ROLLER CLAMP AND THE SLIDE CLAMP ARE CLOSED. EVEN WHEN BOTH CLAMPS ARE CLOSED, THE TUBING STILL LEAKS, AND IF THE END OF THE TUBING IS RAISED ABOVE THE BAG, AIR FLOWS INTO THE END OF THE TUBING."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11021288 ↗
• MalfunctionDec 16, 2020Free or Unrestricted Flow; Infusion or Flow Problem; Free or Unrestricted Flow; Infusion or Flow Problem

  EVENT 1: AS REPORTED BY THE USER FACILITY: "WE HAVE NOTICED THAT THE FILTERED TUBING WE HAVE BEEN USING IS LEAKING AT THE END PORT BETWEEN TWO OF THE PLASTIC PIECES. THIS IS HAPPENING EVEN WHEN THE ROLLER CLAMP AND THE SLIDE CLAMP ARE CLOSED. EVEN WHEN BOTH CLAMPS ARE CLOSED, THE TUBING STILL LEAKS, AND IF THE END OF THE TUBING IS RAISED ABOVE THE BAG, AIR FLOWS INTO THE END OF THE TUBING."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11021285 ↗
• MalfunctionOct 30, 2018Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT DURING CHEMOTHERAPY OF IMFINZI, NURSE OPENED VENT, VENT DETACHED FROM SET AND DRUG SPILLED OUT OF THE AIR VENT. ALL INVOLVED WHERE WEARING PPE AND NO EXPOSURE TO PATIENT OR STAFF. NO INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8019167 ↗
• MalfunctionAug 16, 2018Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED BY THE USER FACILITY: EVENT 1: DURING CHEMOTHERAPY WITH DOCETAXEL, THE IV SET CAME APART WHICH THEN RESULTED IN A LEAK WHICH REQUIRED A CHEMO KIT TO BE USED. NO INJURIES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7791877 ↗
• MalfunctionAug 16, 2018Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED BY THE USER FACILITY: EVENT 2: DURING CHEMOTHERAPY WITH KEYTRUDA, THE VENT POPPED OFF AND THE MEDICATION LEAKED VIA THE VENT REQUIRING A CHEMO KIT TO BE USED. NO INJURIES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7791873 ↗
• MalfunctionJul 19, 2018Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED BY THE USER FACILITY: EVENT 2: ISSUE: CUSTOMER IS FINDING HOLES IN THE TUBING CAUSING CHEMO LEAKS. CUSTOMER EXPLAINED THEY PRIME UNDER THE HOOD AND HAVE NOT FOUND THE ISSUE THERE. UPON TAKING THE CHEMOTHERAPY TO THE PATIENT, A LEAK IS NOTED CAUSING A CHEMO SPILL. THEY EXAMINED THE SETS AND NOTED HOLES IN THE TUBING LIKE THE TUBING WAS NOT FORMED CORRECTLY. THE CHEMOTHERAPY SPILLED ON FLOOR WITH NO CONTACT TO ANYONE NOT PROTECTED, BUT DID REQUIRE SPILL KITS FOR CLEANUP. NO INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7704643 ↗
• MalfunctionJul 19, 2018Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED BY THE USER FACILITY: EVENT 1: ISSUE: CUSTOMER IS FINDING HOLES IN THE TUBING CAUSING CHEMO LEAKS. CUSTOMER EXPLAINED THEY PRIME UNDER THE HOOD AND HAVE NOT FOUND THE ISSUE THERE. UPON TAKING THE CHEMOTHERAPY TO THE PATIENT, A LEAK IS NOTED CAUSING A CHEMO SPILL. THEY EXAMINED THE SETS AND NOTED HOLES IN THE TUBING LIKE THE TUBING WAS NOT FORMED CORRECTLY. THE CHEMOTHERAPY SPILLED ON FLOOR WITH NO CONTACT TO ANYONE NOT PROTECTED, BUT DID REQUIRE SPILL KITS FOR CLEANUP. NO INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7704637 ↗
• MalfunctionJul 19, 2018Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED BY THE USER FACILITY: EVENT 3: ISSUE: CUSTOMER IS FINDING HOLES IN THE TUBING CAUSING CHEMO LEAKS. CUSTOMER EXPLAINED THEY PRIME UNDER THE HOOD AND HAVE NOT FOUND THE ISSUE THERE. UPON TAKING THE CHEMOTHERAPY TO THE PATIENT, A LEAK IS NOTED CAUSING A CHEMO SPILL. THEY EXAMINED THE SETS AND NOTED HOLES IN THE TUBING LIKE THE TUBING WAS NOT FORMED CORRECTLY. THE CHEMOTHERAPY SPILLED ON FLOOR WITH NO CONTACT TO ANYONE NOT PROTECTED, BUT DID REQUIRE SPILL KITS FOR CLEANUP. NO INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7704636 ↗
• MalfunctionJul 19, 2018Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED BY THE USER FACILITY: EVENT 4: ISSUE: CUSTOMER IS FINDING HOLES IN THE TUBING CAUSING CHEMO LEAKS. CUSTOMER EXPLAINED THEY PRIME UNDER THE HOOD AND HAVE NOT FOUND THE ISSUE THERE. UPON TAKING THE CHEMOTHERAPY TO THE PATIENT, A LEAK IS NOTED CAUSING A CHEMO SPILL. THEY EXAMINED THE SETS AND NOTED HOLES IN THE TUBING LIKE THE TUBING WAS NOT FORMED CORRECTLY. THE CHEMOTHERAPY SPILLED ON FLOOR WITH NO CONTACT TO ANYONE NOT PROTECTED, BUT DID REQUIRE SPILL KITS FOR CLEANUP. NO INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7704632 ↗
• MalfunctionJul 13, 2018Infusion or Flow Problem; Infusion or Flow Problem

  AS REPORTED BY THE USER FACILITY: CUSTOMER REPORTS PROBLEM WITH AIR BEING PULLED FROM THE UPPER Y INTO TUBING WHEN RUNNING ON VITA BASIC PUMP. THE AIR BUBBLES CAUSES THE PUMP TO ALARM, WHICH IT SHOULD, BUT SMALL AIR BUBBLES ARE OFTEN SEEN FROM UPPER Y. NO INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7687424 ↗
• MalfunctionDec 2, 2016Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED BY USER FACILITY: LEAKING AT LOWEST Y SITE AT BONDED AREA WHILE CHEMO INFUSING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6142263 ↗
• MalfunctionDec 2, 2016Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED BY USER FACILITY: LEAKING FROM THE VENT WHILE CHEMO WAS IN USE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6142253 ↗