Level 1 D-100Recalls & reported problems

Summary

The FDA's MAUDE database contains 85 adverse event reports that list this exact device (DI 40695085410004), received between Feb 5, 2020 and May 18, 2026 — classified as 85 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (58 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 25 most recent of 85 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 18, 2026Fluid/Blood Leak

  IT WAS REPORTED BY RN THAT LEVEL 1 RAPID INFUSER WAS USED TO ADMINISTER WARMED BLOOD PRODUCTS RAPIDLY FOR A CAT 1 TRAUMA PATIENT. DURING SETUP OF THE EQUIPMENT THE BLOOD STARTED TO LEAK FROM THE FILTER SECTION OF THE TUBING WHICH CAUSED LEAKAGE ONTO THE FLOOR. THERE WAS PATIENT INVOLVEMENT WITH NO HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25201066 ↗
• MalfunctionDec 8, 2025Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT THE TUBING HAD CRACKED AND WAS LEAKING BLOOD DURING A BLOOD TRANSFUSION. PER REPORTER, THEY REPRIMED ANOTHER SET AND CONTINUED WITHOUT A PROBLEM. THE EVENT OCCURRED WHILE IN USE WITH PATIENT. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23741942 ↗
• MalfunctionOct 22, 2025Fluid/Blood Leak; Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING MASSIVE BLOOD TRANSFUSION, A CRACK WAS NOTED AT THE LEVEL 1 TUBING Y BIFURCATION THAT ALLOWED BLOOD TO LEAK AND NECESSITATED TUBING REPLACEMENT. THERE WAS A PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23360640 ↗
• MalfunctionApr 1, 2025Separation Problem; Separation Problem

  IT WAS REPORTED THAT THE CLEAR TUBING SEPARATED FROM THE WHITE PLASTIC ADAPTER CONNECTED TO THE LONGER STURDY TUBING DURING THE EXERCISE. THE DATE OF EVENT WAS ON (B)(6) 2025. THE EVENT OCCURRED DURING USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21740242 ↗
• MalfunctionMar 13, 2025Device Contamination with Body Fluid; Device Contamination with Body Fluid

  IT WAS REPORTED THAT DURING INFUSION THE DEVICE, WARMING, BLOOD AND PLASMA IV SET CAUSED THE RESERVOIR OF THE FLUID WARMER TO FILL WITH BLOOD. THE REPORTER STATED THERE WAS NO MEDICAL INTERVENTION REQUIRED, BLOOD INFUSION DISCONTINUED. NO PATIENT ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21596251 ↗
• MalfunctionFeb 7, 2025Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT THE BLOOD BAG TOOK 7-8 MINUTES TO EMPTY WHEN IT SHOULD HAVE TAKEN LESS THAN A MINUTE. THE ISSUE WAS NOTICED WHILE USING THE DISPOSABLE SET ON THE PATIENT. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21333081 ↗
• MalfunctionJan 2, 2025Insufficient Flow or Under Infusion; Material Twisted/Bent; Insufficient Flow or Under Infusion; Material Twisted/Bent

  IT WAS REPORTED THAT THE FLOW RATE WAS NOTICEABLY SLOW. THE TUBING CAME OUT OF THE BOX WITH A SLIGHT KINK JUST AFTER THE GAS VENT. STRAIGHTENING THE KINK DIDN'T IMPROVE THE FLOW RATE. THEY NOTICED THE SPIKE INSERTED INTO THE IV BAG WAS TWISTED, WHICH WAS IMPEDING THE FLOW. UNTWISTING THE SPIKE INCREASED THE FLOW RATE. SPIKING THE BAGS REQUIRED SIGNIFICANT FORCE AND TWISTING DUE TO THE LENGTH AND TIGHT FIT OF THE SPIKES. ADDITIONALLY, THE NEW TUBING SETS HAVE A LONGER LENGTH OF TUBING ABOVE THE HEAT EXCHANGER, WHICH TENDS TO TWIST AS WELL. THERE WAS PATIENT INVOLVEMENT, AND NO HARM/ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21056150 ↗
• MalfunctionDec 31, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING TRANSFUSION, THE TUBING BEGAN SPRAYING BLOOD ON THE FLOOR. IT WAS FOUND THAT THE LUER LOCK CONNECTION CLOSEST TO THE PATIENT HAD BECOME DISCONNECTED CAUSING THE BLOOD TO SPRAY ON THE FLOOR AND THE REGISTERED NURSE. NO HARM WAS REPORTED TO THE PATIENT AS A RESULT OF THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21048543 ↗
• MalfunctionMay 14, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE TUBING LEAKED FROM THE ACTUAL TRANSFUSER. IT LEAKED FROM THE BOTTOM END OF THE HEAT EXCHANGER (THE END NEAR THE GAS VENT/FILTER ASSEMBLY) THAT PUSHED INTO BLOCK #1 ON THE RAPID TRANSFUSER DEVICE. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19313024 ↗
• MalfunctionJan 12, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE TUBING WAS LEAKING DURING "MASSIVE TRANSFUSION". HAD TO REPLACE AND REPRIME THE DEVICE DURING A SURGICAL CASE. NURSES OBSERVED THE LEAK THAT WAS NOTED TO BE IN BETWEEN THE HARD PLASTIC AND THE SOFT TUBING. NO PATIENT INJURY OR CLINICAL AFFECTS WAS REPORTED. A POSSIBLE LOT NUMBER WAS PROVIDED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18505548 ↗
• MalfunctionDec 28, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING PATIENT USE BLOOD LEAKED FROM THE TUBING. NO PATIENT HARM WITH NO MEDICAL INTERVENTION REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18411046 ↗
• MalfunctionDec 28, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING PATIENT USE BLOOD LEAKED FROM THE TUBING. NO PATIENT HARM WITH NO MEDICAL INTERVENTION REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18411034 ↗
• MalfunctionDec 28, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING PATIENT USE BLOOD LEAKED FROM THE TUBING. NO PATIENT HARM WITH NO MEDICAL INTERVENTION REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18411031 ↗
• MalfunctionNov 13, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WAS LEAKAGE ASSOCIATED WITH THE PRODUCT. PATIENT INVOLVEMENT UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 18124193 ↗
• MalfunctionOct 19, 2023Fitting Problem; Device Contamination with Chemical or Other Material; Material Protrusion/Extrusion; Fitting Problem; Device Contamination with Chemical or Other Material; Material Protrusion/Extrusion

  ADDITIONAL INFORMATION WAS RECEIVED: "OBTAINED THE EVENT WAS RESOLVED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17967011 ↗
• MalfunctionSep 19, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING A BLOOD ADMINISTRATION THE TUBING STARTED LEAKING BLOOD ATTACHED TO THE BLOOD WARMER. THERE WAS PATIENT INVOLVEMENT, BUT NO CLINICAL OR PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17777429 ↗
• MalfunctionJun 29, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A LEAK WAS NOTICED AT THE Y SITE ON THE SPIKING SET TO THE BAG. NO PATIENT INJURY WAS REPORTED. THE OUTCOME WAS RESOLVED BY USING ANOTHER SET OF TUBING AND IT WAS SPIKED WITH NO LEAKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17227517 ↗
• MalfunctionJun 29, 2023Fluid/Blood Leak; Deformation Due to Compressive Stress; Scratched Material; Fluid/Blood Leak; Deformation Due to Compressive Stress; Scratched Material

  IT WAS REPORTED THAT UPON OPENING, THERE WERE KINKS IN THE LINE, SLICE MARKS IN TUBING, AND LEAKING AT CONNECTION POINTS. TWO LOT NUMBERS, 4344926 AND 4273794, WERE REPORTED. NO ADVERSE PATIENT EFFECTS OR INJURY WERE REPORTED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17226633 ↗
• MalfunctionJun 29, 2023Fluid/Blood Leak; Deformation Due to Compressive Stress; Scratched Material; Fluid/Blood Leak; Deformation Due to Compressive Stress; Scratched Material

  IT WAS REPORTED THAT UPON OPENING, THERE WERE KINKS IN THE LINE, SLICE MARKS IN TUBING, AND LEAKING AT CONNECTION POINTS. TWO LOT NUMBERS, 4344926 AND 4273794, WERE REPORTED. NO ADVERSE PATIENT EFFECTS OR INJURY WERE REPORTED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17226631 ↗
• MalfunctionJun 29, 2023Fluid/Blood Leak; Deformation Due to Compressive Stress; Scratched Material; Fluid/Blood Leak; Deformation Due to Compressive Stress; Scratched Material

  IT WAS REPORTED THAT UPON OPENING, THERE WERE KINKS IN THE LINE, SLICE MARKS IN TUBING, AND LEAKING AT CONNECTION POINTS. TWO LOT NUMBERS, 4344926 AND 4273794, WERE REPORTED. NO ADVERSE PATIENT EFFECTS OR INJURY WERE REPORTED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17226623 ↗
• MalfunctionJun 29, 2023Fluid/Blood Leak; Deformation Due to Compressive Stress; Scratched Material; Fluid/Blood Leak; Deformation Due to Compressive Stress; Scratched Material

  IT WAS REPORTED THAT UPON OPENING, THERE WERE KINKS IN THE LINE, SLICE MARKS IN TUBING, AND LEAKING AT CONNECTION POINTS. TWO LOT NUMBERS, 4344926 AND 4273794, WERE REPORTED. NO ADVERSE PATIENT EFFECTS OR INJURY WERE REPORTED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17226620 ↗
• MalfunctionJun 29, 2023Fluid/Blood Leak; Deformation Due to Compressive Stress; Scratched Material; Fluid/Blood Leak; Deformation Due to Compressive Stress; Scratched Material

  IT WAS REPORTED THAT UPON OPENING, THERE WERE KINKS IN THE LINE, SLICE MARKS IN TUBING, AND LEAKING AT CONNECTION POINTS. TWO LOT NUMBERS, 4344926 AND 4273794, WERE REPORTED. NO ADVERSE PATIENT EFFECTS OR INJURY WERE REPORTED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17226584 ↗
• MalfunctionJun 29, 2023Fluid/Blood Leak; Deformation Due to Compressive Stress; Scratched Material; Fluid/Blood Leak; Deformation Due to Compressive Stress; Scratched Material

  IT WAS REPORTED THAT UPON OPENING, THERE WERE KINKS IN THE LINE, SLICE MARKS IN TUBING, AND LEAKING AT CONNECTION POINTS. TWO LOT NUMBERS, 4344926 AND 4273794, WERE REPORTED. NO ADVERSE PATIENT EFFECTS OR INJURY WERE REPORTED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17226577 ↗
• MalfunctionJun 29, 2023Fluid/Blood Leak; Deformation Due to Compressive Stress; Scratched Material; Fluid/Blood Leak; Deformation Due to Compressive Stress; Scratched Material

  IT WAS REPORTED THAT UPON OPENING, THERE WERE KINKS IN THE LINE, SLICE MARKS IN TUBING, AND LEAKING AT CONNECTION POINTS. TWO LOT NUMBERS, 4344926 AND 4273794, WERE REPORTED. NO ADVERSE PATIENT EFFECTS OR INJURY WERE REPORTED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17226573 ↗
• MalfunctionJun 29, 2023Fluid/Blood Leak; Deformation Due to Compressive Stress; Scratched Material; Fluid/Blood Leak; Deformation Due to Compressive Stress; Scratched Material

  IT WAS REPORTED THAT UPON OPENING, THERE WERE KINKS IN THE LINE, SLICE MARKS IN TUBING, AND LEAKING AT CONNECTION POINTS. TWO LOT NUMBERS, 4344926 AND 4273794, WERE REPORTED. NO ADVERSE PATIENT EFFECTS OR INJURY WERE REPORTED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17226496 ↗