Level 1 D-300Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 20695085430008), received between Dec 21, 2017 and Oct 23, 2025 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (8 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 23, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WAS A SINGULAR POINT OF FAILURE WHERE BLOOD LEAKED OUT, NOT A LOT OF BLOOD LEAKED OUT, BUT ENOUGH TO KEEP THE PRESSURE ALARM ON THAT CAUSED THE NURSES TO USE A PRESSURE BAG IN LIEU OF THE LEVEL 1. THERE WAS UNKNOWN REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23368700 ↗
• MalfunctionJul 21, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PRODUCT LEAKED AT Y PORT CONNECTION. PER REPORTER, THIS IS THE SECOND TIME THIS HAPPENED. NO OTHER INFORMATION WAS ABLE TO BE OBTAINED SURROUNDING THE SECOND OCCURRENCE. THERE WAS UNKNOWN PATIENT INVOLVEMENT. NO PATIENT HARM/ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22554173 ↗
• MalfunctionMay 21, 2025Fluid/Blood Leak; Fluid/Blood Leak

  AN EMAIL WAS RECEIVED FROM A VP OF GLOBAL REGULATORY AFFAIRS, FORWARDING A COMPLAINT ON BEHALF OF (B)(6) CENTER REGARDING A BLOOD-FLUID ADMIN/WRM SET 10/CA WITH LIST NUMBER: D-300 AND LOT NUMBER: 4469639. IT WAS REPORTED THAT DURING ON A CODE CRIMSON, THE LEVEL ONE TUBING BEGAN TO LEAK BLOOD FROM THE Y SITE. THE TUBING WAS THEN REMOVED FROM THE PATIENT AND ALSO THE LEVEL ONE INFUSER. THE ORIGINAL INTENDED PROCEDURE WAS A BLOOD TRANSFUSION HOWEVER THE DEVIVE MALFUNCTIONED. NOT A SINGLE USE DEVICE THAT WAS REPROCESSED AND REUSED ON A PATIENT. THERE WAS PATIENT INVOLVEMENT BUT PATIENT WAS NOT INJURED/HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22062496 ↗
• MalfunctionJan 10, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A LEAK WAS FOUND IN THE TUBING FOR A RAPID INFUSER AFTER RAPID INFUSION WAS INITIATED. THE LEAK WAS FOUND DURING INFUSION AT THE Y-JUNCTION OF THE TUBING. A NEW TUBING WAS PRIMED AND CONNECTED TO THE INFUSER AFTER THE OLD TUBING WAS DISCARDED DUE TO THE LEAK. HOWEVER, A LEAK WAS FOUND IN THE NEW TUBING AS WELL. NO HARM TO THE PATIENT WAS NOTED EXCEPT THAT THE PATIENT RECEIVED COLD BLOOD INSTEAD OF WARM BLOOD. BOTH TUBING SETS WERE DISCARDED BY STAFF. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21125730 ↗
• MalfunctionJan 6, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT THEY RECEIVED 3 BOXES OF TUBING WHERE THEY CAME IN DISCONNECTED. THE REPORTER STATED THE TUBING WAS IN 4 PIECES. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21080345 ↗
• MalfunctionJan 6, 2025

  A LEAK WAS FOUND IN THE TUBING FOR A RAPID INFUSER AFTER RAPID INFUSION WAS INITIATED. THE LEAK WAS FOUND DURING INFUSION AT Y-JUNCTION OF THE TUBING. A NEW TUBING WAS PRIMED AND CONNECTED TO THE INFUSER AFTER THE OLD TUBING WAS DISCARDED DUE TO THE LEAK. HOWEVER, A LEAK WAS FOUND IN THE NEW TUBING AS WELL. NO HARM TO THE PATIENT WAS NOTED EXCEPT THAT THE PATIENT RECEIVED COLD BLOOD INSTEAD OF WARM BLOOD. BOTH TUBING SETS WERE DISCARDED BY STAFF. THE BOX SAYS THAT THE IV TUBING WAS "HELIUM LEAK TESTED" BUT IT STILL LEAKED. OUR MATERIALS MANAGER WILL BE NOTIFYING THE MANUFACTURER ABOUT THIS DEFECTIVE PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21078649 ↗
• MalfunctionMay 14, 2024Break; Disconnection; Break; Disconnection

  IT WAS REPORTED THAT THE HUB OF THE TUBING (DISTAL END THAT SCREWS "CUFF" PORTION ONTO THE LUER LOCK OF THE PATIENT'S INTRAVENOUS ACCESS) BROKE OFF WHILE INFUSING THE PRODUCT. THE ORIGINAL INTENDED PROCEDURE WAS MASSIVE (BLOOD)TRANSFUSION PROTOCOL. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT INJURY/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19314751 ↗
• MalfunctionMar 6, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A THE RAPID INFUSER TUBING WAS LEAKING. THERE HAS BEEN NO REPORT OF PATIENT INVOLVEMENT OR NO OBSERVABLE CLINICAL SYMPTOMS OR A CHANGE IN SYMPTOMS IDENTIFIED IN THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 16487619 ↗
• MalfunctionMar 6, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A THE RAPID INFUSER TUBING WAS LEAKING. THERE HAS BEEN NO REPORT OF PATIENT INVOLVEMENT, NO OBSERVABLE CLINICAL SYMPTOMS, OR A CHANGE IN SYMPTOMS IDENTIFIED IN THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 16487107 ↗
• MalfunctionOct 22, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE DEVICE TUBING LEAKED ON SETUP. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15656351 ↗
• MalfunctionOct 22, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE DEVICE TUBING LEAKED ON SETUP. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15656344 ↗
• MalfunctionApr 16, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT WHEN PRIMED, A SMALL AMOUNT OF WATER WAS LEAKING ON THE FLOOR. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14131562 ↗
• MalfunctionFeb 9, 2020Fluid/Blood Leak; Leak/Splash; Loose or Intermittent Connection; Fluid/Blood Leak; Leak/Splash; Loose or Intermittent Connection

  INFORMATION WAS RECEIVED THAT UPON PRIMING THE TUBING ON A SMITHS MEDICAL LEVEL 1 NORMOTHERMIC IV FLUID ADMIN SET, IT WAS LEAKING AT ONE OF THE PRIMING SPIKE. NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9685106 ↗
• MalfunctionDec 21, 2017Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT A LEAK ON THE Y-CONNECTOR OF A LEVEL 1® DISPOSABLE NORMOTHERMIC IV ADMINISTRATION SET DURING INTRAVENOUS AND BLOOD TRANSFUSION. THE INCIDENT OCCURRED IMMEDIATELY UPON USE. IT WAS REPORTED THAT THERE WAS NO PATIENT INJURY AND NO MEDICAL INTERVENTION REQUIRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7137835 ↗
• MalfunctionDec 21, 2017Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT A LEAK ON THE Y-CONNECTOR OF A LEVEL 1® DISPOSABLE NORMOTHERMIC IV ADMINISTRATION SET DURING INTRAVENOUS AND BLOOD TRANSFUSION. THE INCIDENT OCCURRED IMMEDIATELY UPON USE. IT WAS REPORTED THAT THERE WAS NO PATIENT INJURY AND NO MEDICAL INTERVENTION REQUIRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7137817 ↗
• MalfunctionDec 21, 2017Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT A LEAK ON THE Y-CONNECTOR OF A LEVEL 1® DISPOSABLE NORMOTHERMIC IV ADMINISTRATION SET DURING INTRAVENOUS AND BLOOD TRANSFUSION. THE INCIDENT OCCURRED IMMEDIATELY UPON USE. IT WAS REPORTED THAT THERE WAS NO PATIENT INJURY AND NO MEDICAL INTERVENTION REQUIRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7137809 ↗