Level 1 DI-100Recalls & reported problems

Summary

The FDA's MAUDE database contains 131 adverse event reports that list this exact device (DI 20695085410017), received between Jan 21, 2020 and Jul 10, 2026 — classified as 3 deaths, 128 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (88 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 131 reports, in the reporter's own words as published by the FDA.

• DeathJul 10, 2026Obstruction of Flow

  IT WAS REPORTED THAT THE PATIENT WAS IN CARDIAC ARREST FROM A DISSECTION. THEY WERE ATTEMPTING TO GIVE MULTIPLE UNITS OF BLOOD THROUGH THE LEVEL 1 INFUSER, BUT THE TUBING KEPT KINKING AND THIS CAUSED DECREASED FLOW AND PROLONGED TIME TO GIVE BLOOD TO THE PATIENT. THEY HAD TO SUPPLEMENT THE LEVEL 1 INFUSER WITH GIVING BLOOD THROUGH A PRESSURE BAG UNTIL THEY COULD GET THE TUBING UNKINKED. THEY WERE UNABLE TO PUNCTURE BLOOD BAG WITH LEVEL 1 INFUSER TUBING IN A CRITICAL SITUATION WITH A PATIENT. IT TOOK SEVERAL TRIES BY MULTIPLE PEOPLE TO PUNCTURE THE BLOOD BAG WITH THE TUBING. THE PATIENT ULTIMATELY DID NOT SURVIVE. THERE WAS PATIENT INVOLVEMENT, AND PATIENT DEATH WAS REPORTED WHILE USING ICU PRODUCT. THE DEVICE AND PATIENT DEATH WERE NOT RELATED. MEDICAL EVALUATION: BASED ON THE AVAILABLE INFORMATION, THERE IS NO OBJECTIVE EVIDENCE CONFIRMING A DEVICE MALFUNCTION, AS NO DEVICE OR LOT WAS AVAILABLE FOR EVALUATION. ADDITIONALLY, ALTERNATIVE TRANSFUSION METHODS WERE SUCCESSFULLY EMPLOYED TO CONTINUE THERAPY. WHILE THE REPORTED DEVICE PERFORMANCE ISSUES MAY HAVE CONTRIBUTED TO PROCEDURAL DELAYS, THE PRIMARY CAUSE OF DEATH IS MOST CONSISTENT WITH THE UNDERLYING MEDICAL CONDITION. IN SUMMA

  Patient problems: Cardiac Arrest

  MAUDE report 25782353 ↗
• MalfunctionJun 2, 2026Collapse; No Flow

  IT WAS REPORTED THAT THE ADMINISTRATION LINE DID NOT FUNCTION AS INTENDED. THE TEAM WAS ABLE TO FLUSH THE LINE WITH SODIUM CHLORIDE (NACL 0.9%); HOWEVER, NO FLOW WAS OBSERVED AT THE BRANCH CONNECTION, AND THE TUBING WAS NOTED TO BE COLLAPSED. PATIENT INVOLVEMENT IS UNKNOWN, AND NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25363018 ↗
• MalfunctionMay 7, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WAS A BLOOD LEAKAGE AT THE CONNECTION PART. THE EVENT OCCURRED IMMEDIATELY ON USE AT THE HOSPITAL. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND THERE WAS NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25113692 ↗
• MalfunctionDec 31, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT INFUSION LEAKED FROM THE BOTTOM OF THE SPIKE AFTER THE IV SET WAS FASTENED TO THE EQUIPMENT AND WHILE IN USE WITH A PATIENT. NO PATIENT HARM/ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23935665 ↗
• MalfunctionDec 31, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT INFUSION LEAKED FROM THE BOTTOM OF THE SPIKE AFTER THE IV SET WAS FASTENED TO THE EQUIPMENT AND WHILE IN USE WITH A PATIENT. NO PATIENT HARM/ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23933521 ↗
• MalfunctionOct 24, 2025Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT ONCE INFUSION OF BLOOD PRODUCTS BEGAN, STAFF NOTED THAT THE CLAMPS ON THE SIDE NOT BEING USED WEREN'T CLAMPING TIGHTLY ENOUGH AND BLOOD WAS BACK FLOWING INTO THE OTHER SIDE. THEY TRIED TO MOVE THE CLAMP UP AND DOWN THE TUBING, BUT NO DIFFERENCE NOTED. IT REQUIRED A STAFF TO MANUALLY PINCH THE TUBING TO STOP BACKFLOW. STAFF ALSO NOTED THAT THE TUBING CONNECTED TO THE RIGHT SIDE WAS NOT INFUSING AT A SUFFICIENT RATE, NOTED TO ONLY BE ¿TRICKLING¿ OUT. STAFF SWITCHED TO THE OTHER SIDE, AND IT FUNCTIONED PROPERLY TO INFUSE THE BLOOD PRODUCTS AT A FAST RATE. THERE WAS PATIENT INVOLVEMENT, AND NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23384116 ↗
• MalfunctionSep 15, 2025Disconnection; Fluid/Blood Leak; Insufficient Flow or Under Infusion; Disconnection; Fluid/Blood Leak; Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT THE BLOOD WAS INFUSING SLOWLY THROUGH THE RAPID INFUSER. REPORTER STATED THAT THE INFUSER WAS PRIMED PRIOR TO BLOOD INFUSION BY A NURSE, AND WHEN HANGING A UNIT OF BLOOD VIA THE RAPID INFUSER, THE INFUSER WAS ADVISING TO RE-INSERT THE SET AND WAS CONTINUALLY BEEPING. REPORTER STATED THE INFUSION SET WAS REMOVED AND THE TUBING CAME UNATTACHED AT THE BOTTOM PORT, CAUSING THE BLOOD TO DRAIN ON THE FLOOR. NO SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23052906 ↗
• MalfunctionSep 15, 2025Obstruction of Flow; Air/Gas in Device; Obstruction of Flow; Air/Gas in Device

  IT WAS REPORTED THAT DURING, DURING RED BLOOD CELL INFUSION, THE INFUSION WAS TOO SLOW. REPORTER STATED THAT THE FIRST UNIT OF RED BLOOD CELL INFUSED APPROPRIATELY, AND DURING INFUSION OF THE SECOND SET, TROUBLESHOOTING FOUND DIFFICULTY WITH THE HEAT EXCHANGE UNIT SLIDE DOWN ON STEP 2 OF SET UP. REPORTER STATED THAT AIR WAS ALSO NOTED IN THE Y PORT OF THE BETWEEN COLLECTION DRIP CHAMBERS, POTENTIALLY IMPEDING FLOW. REPORTER STATED THAT TWO ADDITIONAL UNITS OF PACKED RED BLOOD CELLS WERE GIVEN AND THEN THE RATE SLOWED, AND THAT THEY NOTED A PROBLEM WITH THE TUBING SPIKE LENGTH KINKING IN THE PRESSURE CHAMBER. NO SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23052849 ↗
• MalfunctionSep 15, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT THE IV SET WAS NOT INFUSING AS QUICKLY AS IT WAS SUPPOSED TO. PER REPORTER, THIS ISSUE OCCURRED DURING USE WITH A HYPOVOLEMIC SHOCK PATIENT WHO HAD ARRESTED AND CAUSED A DELAY IN THERAPY. NO SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23052780 ↗
• MalfunctionJul 15, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE FLUID LEAKED IN THE CLAPPED CHAMBER AT THE BOTTOM OF THE PRODUCT¿S INFUSION CONNECTION. PER REPORTER, THE EVENT OCCURRED AT THE HOSPITAL AND THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22507244 ↗
• MalfunctionApr 23, 2025Free or Unrestricted Flow; Free or Unrestricted Flow

  IT WAS REPORTED THAT THE CLAMP WAS NOT PREVENTING THE LIQUID FROM CIRCULATING AND CREATED INCREASED ARTERIAL HYPOTENSION IN THE CONTEXT OF HEMORRHAGIC HYPOVOLEMIC SHOCK.

  Patient problems: Hypovolemic Shock

  MAUDE report 21893564 ↗
• DeathMar 31, 2025Collapse; Fluid/Blood Leak; Insufficient Flow or Under Infusion; Collapse; Fluid/Blood Leak; Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT SPIKING THE BLOOD TUBING WAS DIFFICULT AND THE DEVICE HAD A LOW FLOW RATE. THERE WAS LEAKING FROM THE BAG AROUND THE SPIKE AND DRIP CHAMBERS, WHICH HAD COLLAPSED DURING INFUSION. THE PATIENT WAS PART OF A MASSIVE TRANSFUSION PROTOCOL AND HAD RECEIVED MULTIPLE BLOOD PRODUCTS AS WELL AS MEDICATIONS. THOUGH THE PATIENT DID RECEIVE BLOOD AND TREATMENT, THE PATIENT ULTIMATELY PASSED AWAY. THE PRODUCT THAT WAS INITIALLY USED IS STILL AVAILABLE AND DOES HAVE COAGULATED BLOOD THROUGHOUT THE TUBING WHICH WAS UNABLE TO BE FLUSHED. A REVIEW BY THE ICU MEDICAL TEAM WAS COMPLETED AND THEY FOUND THAT THE LACK OF DETAILS REGARDING THIS CLINICAL EVENT PRECLUDES A COMPREHENSIVE MEDICAL ASSESSMENT. BASED ON A REVIEW OF THE EVENTS IN THIS CASE, THE CUMULATIVE EVIDENCE DOES NOT ALLOW FOR ANY CONCLUSIONS TO BE DRAWN FOR THIS INCIDENT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS MEDICAL ASSESSMENT WILL BE REVISED AS NEEDED.

  Patient problems: Insufficient Information

  MAUDE report 21731043 ↗
• DeathFeb 3, 2025Collapse; Fluid/Blood Leak; Insufficient Flow or Under Infusion; Collapse; Fluid/Blood Leak; Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT SPIKING THE BLOOD TUBING WAS DIFFICULT AND THE DEVICE HAD A LOW FLOW RATE. THERE WAS LEAKING FROM THE BAG AROUND THE SPIKE AND DRIP CHAMBERS, WHICH HAD COLLAPSED DURING INFUSION. THE PATIENT WAS PART OF A MASSIVE TRANSFUSION PROTOCOL AND HAD RECEIVED MULTIPLE BLOOD PRODUCTS AS WELL AS MEDICATIONS. THOUGH THE PATIENT DID RECEIVE BLOOD AND TREATMENT, THE PATIENT ULTIMATELY PASSED AWAY. THE PRODUCT THAT WAS INITIALLY USED IS STILL AVAILABLE AND DOES HAVE COAGULATED BLOOD THROUGHOUT THE TUBING WHICH WAS UNABLE TO BE FLUSHED.

  Patient problems: Insufficient Information

  MAUDE report 21294048 ↗
• MalfunctionJan 29, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A HIGH FLOW TUBING SPLIT HAPPENED DURING THE TRANSFUSION PROTOCOL. THERE WAS BLOOD LEAK AND POSSIBLE CONTAMINATION. THERE WERE NO ADVERSE EVENTS REPORTED DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21266351 ↗
• MalfunctionJan 3, 2025Defective Component; Defective Component

  IT WAS REPORTED THAT THE DEVICE WAS NOT ABLE TO SPIKE A BLOOD BAG DURING A LEVEL 1 TRAUMA SITUATION WHERE THE PATIENT WAS HEMORRHAGING BLOOD. THE CUSTOMER STATED THAT THE TUBING WAS NOT SPIKING AND WAS NOT FITTING APPROPRIATELY IN THE BAG AND STATES THAT DUE TO THIS, BLOOD WAS NOT GIVEN IN "THE MOST APPROPRIATE METHOD." THERE WAS NO REPORTED PATIENT HARM DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21069149 ↗
• MalfunctionDec 26, 2024Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT ONCE INFUSION OF BLOOD PRODUCTS BEGAN, STAFF NOTED THAT THE CLAMPS ON THE SIDE NOT BEING USED WEREN¿T CLAMPING TIGHTLY ENOUGH AND BLOOD WAS BACK FLOWING INTO THE OTHER SIDE. THEY TRIED TO MOVE THE CLAMP UP AND DOWN THE TUBING, BUT NO DIFFERENCE NOTED. IT REQUIRED A STAFF TO MANUALLY PINCH THE TUBING TO STOP BACKFLOW. STAFF ALSO NOTED THAT THE TUBING CONNECTED TO THE RIGHT SIDE WAS NOT INFUSING AT A SUFFICIENT RATE, NOTED TO ONLY BE ¿TRICKLING¿ OUT. STAFF SWITCHED TO THE OTHER SIDE, AND IT FUNCTIONED PROPERLY TO INFUSE THE BLOOD PRODUCTS AT A FAST RATE. THERE WAS PATIENT INVOLVEMENT, AND NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21020920 ↗
• MalfunctionNov 1, 2023Failure to Sense; Connection Problem; Failure to Sense; Connection Problem

  IT WAS REPORTED THAT THE DEVICE WAS NOT RECOGNIZED AFTER CONNECTING IT TO THE EQUIPMENT. AFTER CHANGING TO A NEW DEVICE OF THE SAME ITEM NUMBER, THE EQUIPMENT WAS AVAILABLE TO USE. NO PATIENT INJURY AND NO MEDICAL INTERVENTION WERE RECORDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18048008 ↗
• MalfunctionAug 23, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WAS LEAKAGE AT THE TUBING PART OF THE DEVICE. THERE HAS BEEN NO REPORT OF PATIENT INJURY.

  Patient problems: Insufficient Information

  MAUDE report 17607644 ↗
• MalfunctionAug 23, 2023Fitting Problem; Connection Problem; Fitting Problem; Connection Problem

  IT WAS REPORTED THAT THE FLUID WARMER WOULD ONLY EMIT "BEEP SOUNDS" WHEN CONNECTING THE DEVICE TO THE MACHINE AND WOULD NOT OPERATE. THERE WERE NO PROBLEMS WHEN CONNECTING OTHER CONSUMABLES TO THE SAME MACHINE. PATIENT INVOLVEMENT UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 17605594 ↗
• MalfunctionAug 3, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE CUSTOMER WAS COMPLETING A TEST RUN. THE 500CC "DAD" BAG WAS CONNECTED TO PURGE; SOLUTION LEAK WAS FOUND IN THE "Y" THAT WAS DIVIDED FOR EACH INFUSION CHAMBER OR CONNECTION TO EACH FLUID. THERE WAS NO PATIENT INVOLVEMENT, NO INJURY OR HARM. IT WAS REPORTED THERE WERE FOUR (4) ITEMS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17450696 ↗
• MalfunctionMay 3, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE DEVICE WAS LEAKING WHEN DEVICE WAS PRESSURIZED PRIOR TO USE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16859796 ↗
• MalfunctionMay 3, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE DEVICE WAS LEAKING WHEN DEVICE WAS PRESSURIZED PRIOR TO USE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16859750 ↗
• MalfunctionApr 17, 2023Obstruction of Flow; Infusion or Flow Problem; Obstruction of Flow; Infusion or Flow Problem

  IT WAS REPORTED THAT A NEWLY DISASSEMBLED LINE WOULD NOT BE VENTED. 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 16751819 ↗
• MalfunctionApr 12, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED OF A DEVICE MALFUNCTION (WATER LEAK). LOT UNKNOWN. DISCOVERED UPON OPENING. NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16725477 ↗
• MalfunctionApr 12, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED OF A DEVICE MALFUNCTION (WATER LEAK). LOT UNKNOWN. DISCOVERED UPON OPENING. NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16725375 ↗