RATE FLOW® 375257Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04046955257164), received between Oct 28, 2023 and Feb 12, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Air/Gas in Device” (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. 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 12, 2024Air/Gas in Device; Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: CUSTOMER REPORTED THAT HER RATEFLOW ADMIN 15 DROP W/1 CARESITE DEVICES HAVE BEEN ONLY FLOWING FROM ABOUT 100 - 200ML.  THE BAGS BEING USED TO MEDICATION ABOUT 1000ML.  THE MEDICINE COMPLETELY STOPS FLOWING AND THE PATIENT HAS TO REPEATEDLY OPEN THE LINE TO RESUME THE FLOW OF MEDS. THERE ARE A LOT OF AIR BUBBLES IN THE LINE (NOT IN THE TUBING) DURING FLUSHING OF THE DEVICE.  WHEN SHE DISCONNECTS AND PRIMES THE TUBING THERE IS NOT AIR IN THE TUBING ITSELF BUT THERE IS AIR ON HER SIDE.  SHE HAS HAD MULTIPLE NURSES COME OUT AND TROUBLE SHOOT - THE POCKETS OF AIR ONLY HAPPEN WHEN SHE TRYING TO MAKE THE DEVICE WORK. WHEN SHE FLUSHES TO LINE IT SEEMS TO WORK BUT SHE HAS TO FLUSH REPEATEDLY TO GET THE 1000ML TO WORK.  THE NURSES HAVE TOLD HER THIS IS HAPPENING TO HER AND THAT SOMETIMES IF THE LINE OPEN FOR  PERIOD OF TIME THE ISSUE IS RESOLVED - THIS IS KIND OF LIKE FLUSHING IT. SUPPOSED TO 125 - 130 MINUTES SHE CANNOT RUN THE MEDICINE LIKE THIS,  THE OPEN DRIP IS THE ONLY WAY SHE CAN GET THIS TO WORK AND IT TAKES TWO - THREE HOURS TO INFUSE THE MEDICATION. SHE IS INFUSING JUST NORMAL SALINE. SHE WILL DO IMPACTFUL MEDS LIKE IRON INFUSION AT THE HOSPITAL. 

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18684801 ↗
• MalfunctionDec 9, 2023Inaccurate Flow Rate; Inaccurate Flow Rate

  AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION: CUSTOMER STATES THE RATES ARE NOT ACCURATE. NEEDED TO USE DRIP ASSISTANT. DETAILED INQUIRY DESCRIPTION: THE RATES AREN'T ACCURATE AT ALL! I'VE HAD TO START USING THE DRIP ASSIST AGAIN. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18298208 ↗
• MalfunctionNov 29, 2023Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION: PATIENT CLAIMING NEW RATE FLOW HAS HIGHER RATE THAN INDICATED. DETAILED INQUIRY DESCRIPTION: PATIENT REPORTS NEW DIAL-A-FLOW TUBING IS ADMINISTERING AT A RATE 2 HOURS GREATER THAN WHAT IS STATED. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18226625 ↗
• MalfunctionOct 28, 2023Air/Gas in Device; Air/Gas in Device

  AS REPORTED BY PATIENT: WE RECEIVED A COMPLAINT FROM A PATIENT REGARDING THE NEW B. BRAUN RATE FLOW SETS. PATIENT FEELS THE NEW SET INVOLVES A SAFETY RISK. I'M NOT AWARE OF ANY GRAVITY TUBING THAT STOPS THE FLOW ONCE THE BAG IS EMPTY. SEE PATIENT COMMENTS BELOW: "I JUST USED THE NEW TUBING PROVIDED FOR THE GRAVITY. IT IS A MAJOR RISK / CONCERN. THE OLD TUBING WOULD NOT CONTINUE ONCE THE BAG WAS EMPTY AND DID NOT ALLOW AIR INTO THE TUBING. THIS NEW ONE HOWEVER DID AND THE AIR MADE IT PAST THE DIAL AND WAS ON ITS WAY INTO MY HEART WHEN I CAUGHT IT. IT APPEARS TO ME BASED UPON THIS EXPERIENCE THIS TUBING IS UNSAFE." NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18026658 ↗