Level 1 8002950Recalls & reported problems

Summary

The FDA's MAUDE database contains 931 adverse event reports that list this exact device (DI 50695085829506), received between Jan 16, 2018 and Sep 25, 2026 — classified as 10 deaths, 1 injury, 920 malfunctions.

The most frequently reported specific device problem is “Device Alarm System” (185 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 931 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50903381 ↗
• DeathMay 21, 2026Insufficient Heating

  IT WAS REPORTED THAT THE INFUSER FAILED TO HEAT THE BLOOD BEING INFUSED, RESULTING IN A DELAY IN THERAPY WHILE A SECOND UNIT WAS SET UP. THE STAFF CONTINUED TO INFUSE THE BLOOD, DUE TO MASSIVE BLOOD TRANSFUSION NEEDED. THIS WAS DURING A CODE SITUATION THEY GAINED ROSC ON THE PATIENT. LATER THE PATIENT WAS TRANSITIONED TO COMFORT CARE AND PASSED AWAY. THIS EVENT OCCURRED DURING INFUSION. BASED ON THE CURRENTLY AVAILABLE COMPLAINT NARRATIVE, A PATIENT DEATH OCCURRED IN THE SETTING OF A CODE EVENT WITH REPORTED MASSIVE BLOOD TRANSFUSION, WHERE IT WAS ALLEGED THAT THE LEVEL 1® FAST FLOW FLUID WARMER FAILED TO HEAT BLOOD DURING INFUSION, RESULTING IN A DELAY IN THERAPY WHILE A SECOND UNIT WAS SET UP; ROSC WAS REPORTEDLY ACHIEVED, THE PATIENT WAS LATER TRANSITIONED TO COMFORT CARE, AND SUBSEQUENTLY DIED. THE PATIENT¿S MEDICAL HISTORY AND KEY CLINICAL CONTEXT ARE NOT PROVIDED, INCLUDING THE UNDERLYING DIAGNOSIS AND CLINICAL CIRCUMSTANCES THAT PRECIPITATED THE CODE EVENT, THE INDICATION FOR AND MAGNITUDE OF THE MASSIVE TRANSFUSION REQUIREMENT, OBJECTIVE TEMPERATURE DATA (PATIENT CORE TEMPERATURE AND/OR DEVICE OUTLET TEMPERATURE), TRANSFUSION VOLUMES AND RATES, THE DURATION OF ANY PERIOD OF

  Patient problems: Insufficient Information

  MAUDE report 25246136 ↗
• DeathApr 27, 2026Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT THE EMERGENCY ROOM STAFF REPORTED A STAFF REPORTED A PATIENT DEATH ASSOCIATED WITH A SUSPECTED DEVICE MALFUNCTION, WHERE THE DEVICE WOULD NOT INFUSE FASTER THAN 10 MINUTES. THE STAFF DOES NOT BELIEVE THE DEATH WAS DUE TO THE SLOW INFUSION OF BLOOD, BUT THEY BELIEVED THE DEVICE MALFUNCTIONED IN THAT IT WAS NOT INFUSING RAPIDLY AS THEY EXPECT TO INFUSE A UNIT OF BLOOD IN 1 TO 3 MINUTES. THE COMPLAINT COULD NOT BE CONFIRMED BECAUSE THE DEVICE WAS NOT RETURNED, AND THERE WAS INSUFFICIENT OBJECTIVE INFORMATION (PHOTOS/LOGS/HISTORY) TO DETERMINE PROBABLE CAUSE OR FAILURE MODE. MEDICAL CAUSALITY / RELATEDNESS ASSESSMENT PATIENT OUTCOME SEVERITY: DEATH. CAUSAL RELATIONSHIP TO DEVICE PERFORMANCE: INDETERMINATE BASED ON CURRENTLY AVAILABLE INFORMATION. RATIONALE: 1. THE ONLY CLINICAL LINKAGE PROVIDED IS A TEMPORAL ASSOCIATION AND AN ALLEGATION OF SLOWER THAN EXPECTED INFUSION; THE REPORTER ALSO STATED STAFF DID NOT BELIEVE THE SLOW INFUSION CAUSED THE DEATH. 2. THE ABSENCE OF DEVICE RETURN, AND OBJECTIVE DEVICE DATA (LOGS/ALARMS/SERVICE HISTORY/PHOTOGRAPHS) PREVENTS CONFIRMATION OF MALFUNCTION, IDENTIFICATION OF FAILURE MODE, OR ASSESSMENT OF WHETHER DEVICE PERFORMANCE D

  Patient problems: Cardiac Arrest

  MAUDE report 25004759 ↗
• MalfunctionApr 9, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE CLINICAL STAFF NOTICED A BURNING SMELL EMANATING FROM THE INFUSER DURING THE INITIATION OF BLOOD PRODUCTS. ADDITIONALLY, A LEAK WAS OBSERVED AT CONNECTION SITE #4 OF THE BLOOD TUBING. THE TUBING WAS PRIMED, AND AFTER THE DEVICE WAS PLUGGED IN AND TURNED ON, IT STARTED TO HEAT, AND THE RN NOTICED A LEAK. THE TUBING WAS NOT CONNECTED TO THE PATIENT, AND THE DIAGNOSIS WAS FOR TRAIN VERSUS PEDESTRIAN. THERE WERE NO PATIENT INVOLVEMENT AND NO HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24832529 ↗
• MalfunctionMar 25, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A PERCUTANEOUS RENAL PROCEDURE (PERC) WAS PERFORMED IN ROOM 15. THE PROCEDURE REQUIRED WARMED IRRIGATION. NORMAL SALINE WAS DELIVERED THROUGH A LEVEL 1 FLUID WARMER TO MAINTAIN AN IRRIGATION TEMPERATURE OF AROUND 41°C; HOWEVER, THE MACHINE HAD A COOLING WATER LEAK. MIDWAY THROUGH THE PROCEDURE, THE WRITER NOTICED SMOKE COMING FROM THE MACHINE. IT WAS DETERMINED THAT THE WARMING FUNCTION MALFUNCTIONED, CAUSING THE PLASTIC IRRIGATION TUBING TO BURN. THE WRITER IMMEDIATELY STOPPED USING THE MACHINE, REMOVED THE PLASTIC TUBING, AND CONTACTED MEDICAL EQUIPMENT SERVICES TO ASSESS THE DEVICE. THERE WERE NO ADVERSE EFFECTS ON THE PATIENT AT THAT TIME. THE WARMED NORMAL SALINE SOLUTION REMAINED AT AN APPROPRIATE TEMPERATURE THROUGHOUT THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24688670 ↗
• MalfunctionMar 19, 2026Calibration Problem

  IT WAS REPORTED THAT DURING POST PROCEDURE THE UNIT FAILED THE POST-TEST FOLLOWING THE ONSITE FSE REMEDIATION EFFORTS. DURING THE OVER-TEMPERATURE ALARM SWITCH TEST, THE TEMPERATURE ROSE TO 45.9°C FROM 41.7°C DURING THE CALIBRATION STEP, WHICH WAS OUTSIDE THE TARGET RANGE OF 45.3°C ± 0.4°C. ADDITIONALLY, CORROSION AND POSSIBLE WATER DAMAGE WERE OBSERVED ON THE BOARD. THERE WAS NO PATIENT INVOLVEMENT AND NO HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24638834 ↗
• MalfunctionMar 6, 2026Arcing of Electrodes

  IT WAS REPORTED THAT THE DEVICE WAS ARCING ELECTRICITY BETWEEN RELAYS AND MISSING SOME OF THE DIGITS IN THE DISPLAY AS WELL. THE DEVICE WAS NOT HEATING AND THE ISSUE WAS OBSERVED DURING START UP. THERE WAS NO PATIENT INVOLVEMENT. EVALUATION OF THE RETURNED DEVICE CONFIRMED EVIDENCE OF ELECTRICAL DAMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24532164 ↗
• MalfunctionMar 3, 2026Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT A LEVEL 1 RAPID INFUSER EXPERIENCED SLOW DRIPPING FLOW DURING INFUSION SHORTLY AFTER THE FIRST TWO PACKED RED BLOOD CELLS WERE HUNG. THE PATIENT¿S ACCESS WAS NEW, WITH GOOD BLOOD RETURN AND FLUSH CAPABILITY, AND THE ISSUE WAS NOT RELATED TO THE FILTER. ALL SYSTEM INDICATORS WERE NORMAL. REINSTALLATION OF THE LINE DID NOT RESOLVE THE ISSUE. INTERMITTENT ORANGE ALARMS INDICATED THE BIFOLD DOOR WAS NOT CLOSED PROPERLY, DESPITE BEING PROPERLY POSITIONED. THERE WAS A FIVE-MINUTE THERAPY DELAY, POTENTIALLY PROLONGING HYPOVOLEMIA AND INCREASING VASOPRESSOR REQUIREMENTS. THERE WAS PATIENT INVOLVEMENT, BUT NO HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24499054 ↗
• MalfunctionFeb 5, 2026Failure to Sense

  IT WAS REPORTED THAT THE APPARATUS INVOLVED WITH THE AIR DETECTION TESTING WAS NOT PERFORMING THE CHECK FOR AIR BUBBLES. F1 FUSE ON THE MAIN PRINTED CIRCUIT BOARD IS RESPONSIBLE FOR AIR DETECTION/CLAMP AND THAT THE FUSE HAS BEEN BLOWN THUS LEADING TO THE INACTIVITY OF THE AIR DETECTION APPARATUS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24267928 ↗
• MalfunctionDec 9, 2025No Audible Alarm; Environmental Particulates; No Audible Alarm; Environmental Particulates

  IT WAS REPORTED THAT THE DEVICE EXPERIENCED MULTIPLE ISSUES, INCLUDING INABILITY TO LOAD A SET WITHOUT TRIGGERING ALARMS AND EMITTING A BURNT SMELL DURING SET-UP. THERE WERE NO PATIENT INVOLVEMENT AND HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23760928 ↗
• MalfunctionDec 8, 2025Temperature Problem; Temperature Problem

  IT WAS REPORTED THAT THE UNIT CONTINUOUSLY ALARMED. THE EVENT OCCURRED DURING PATIENT AND THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23744219 ↗
• MalfunctionNov 19, 2025Partial Blockage; Partial Blockage

  IT WAS STATED THAT 30 ML OF BLOOD WAS LEFT FROM THE BAG. THE CHAMBER WAS NOT DRAINING THE WHOLE FLUID, BLOOD. THE PRESSURE IN THE CHAMBERS WAS FINE, 300 MMHG. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23595289 ↗
• MalfunctionNov 12, 2025Failure to Infuse; Failure to Infuse

  IT WAS REPORTED THAT THE DEVICE EMITTED CONTINUOUS ALARM ALERTS DURING PATIENT USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23536592 ↗
• MalfunctionNov 6, 2025Insufficient Flow or Under Infusion; Failure to Infuse; Insufficient Flow or Under Infusion; Failure to Infuse

  PROBLEM: THE BAG NOT EMPTYING COMPLETELY. THERE WAS NO PATIENT HARM/ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23490254 ↗
• MalfunctionNov 6, 2025Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE DEVICE WAS OVERHEATING AND HAD CRACKED TUBING. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23485900 ↗
• MalfunctionNov 4, 2025Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE TEMPERATURE INCREASED UNTIL DEVICE OVERHEATS, TURNING THE TEMPERATURE ALL THE WAY DOWN STILL RESULTED IN A TEMPERATURE OF 43.5 PLUS. A CRACK IN THE RETURN TUBE SPRAYED A STREAM OF WATER EACH TIME THE DEVICE WAS TURNED OFF WHICH MAY HAVE CAUSED THE ISSUE THOUGH THERE WAS NO VISIBLE CORROSION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23469004 ↗
• MalfunctionOct 30, 2025Temperature Problem; Temperature Problem

  IT WAS REPORTED THAT THE DEVICE OVERSHOT THE TARGETED TEMPERATURE AND THEN COOLED DOWN VERY SLOWLY. THE DEVICE DID NOT REACH OR MAINTAIN THE DESIRED TEMPERATURE WITHIN 20 MINUTES OF IDLE TIME AFTER THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT, NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23424869 ↗
• MalfunctionSep 15, 2025Obstruction of Flow; Air/Gas in Device; Obstruction of Flow; Air/Gas in Device

  IT WAS REPORTED THAT DURING RED BLOOD CELL INFUSION, THE INFUSION WAS TOO SLOW. THE 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. THE REPORTER FURTHER STATED THAT AIR WAS ALSO NOTED IN THE Y PORT OF THE BETWEEN COLLECTION DRIP CHAMBERS, POTENTIALLY IMPEDING FLOW. TWO ADDITIONAL UNITS OF PACKED RED BLOOD CELLS WERE GIVEN AND THEN THE RATE SLOWED. THEY NOTED A PROBLEM WITH THE TUBING SPIKE LENGTH KINKING IN THE PRESSURE CHAMBER. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23052320 ↗
• MalfunctionSep 2, 2025Failure to Shut Off; Failure to Shut Off

  IT WAS REPORTED THAT THE FLOAT SWITCH WAS NOT TURNING OFF THE PUMP. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22938518 ↗
• MalfunctionSep 2, 2025No Audible Alarm; Overheating of Device; No Audible Alarm; Overheating of Device

  IT WAS REPORTED THAT THE UNIT OVERHEATED AND DID NOT ALARM. THERE WAS NO LED ILLUMINATION OR AUDIBLE OVER-TEMPERATURE ALARM, EVEN WHEN THE UNIT¿S TEMPERATURE REACHED 46 °C. HOWEVER, THE TEST ALARM FUNCTIONED CORRECTLY¿DURING TESTING, BOTH THE LED AND AUDIBLE ALARM ACTIVATED AS EXPECTED. THE EVENT OCCURRED DURING USE. THE UNIT WAS NOT DROPPED. THERE WAS NO DELAY OF THERAPY. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22932537 ↗
• MalfunctionAug 19, 2025Insufficient Heating; Insufficient Heating

  IT WAS REPORTED THAT UNIT DOES NOT REACH THE OPERATING TEMPERATURE OF 41.7°C (IT ONLY REACHED A MAXIMUM OF 37.2°C) AFTER 30 MINUTES, DESPITE ADJUSTMENT. THE EVENT OCCURRED DURING IMMEDIATELY ON USE. THE EVENT HAPPENED IN THE HOSPITAL, OPERATED BY A HEALTH PROFESSIONAL. THIS WAS NOT REPORTED TO FDA. THE EVENT DID NOT IMPACT PATIENT CARE. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22843995 ↗
• MalfunctionAug 13, 2025Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE DEVICE ALARMING DURING USE THE CONSUMABLE ALARM WAS ALARMING UP BY THE TEMPERATURE DISPLAY. AFTER THE BLOOD BAG WAS REPLACED THE AIR CLAMP SHUT AND ALARMED AND WOULD NO LONGER RELEASE. THE USER COULD NOT INSERT THE NEW TUBE IN THE TRI FOLD DOOR AS THE CLAMP WAS SHUT. THE EVENT OCCURRED DURING PATIENT USE, AND THERE WAS UNKNOWN SIGNS OR SYMPTOMS EXPERIENCED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22797798 ↗
• MalfunctionAug 13, 2025Excessive Heating; Excessive Heating

  IT WAS REPORTED THAT THE DEVICE HAS A CONTINUOUS TEMPERATURE ALARM. IT WAS 20 SECONDS AFTER POWER ON AND IT COULD NOT BE CLEARED. THE EVENT OCCURRED IMMEDIATELY ON USE AT THE HOSPITAL, AND THE ISSUE WAS NOT RESOLVED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22796893 ↗
• MalfunctionAug 11, 2025Circuit Failure; Excessive Heating; Circuit Failure; Excessive Heating

  IT WAS REPORTED THAT A UNIT'S OVER-TEMPERATURE ALARM SOUNDED IMMEDIATELY UPON POWER ON. IT HAD A CONTINUOUS TEMPERATURE ALARM THAT COULD NOT BE CLEARED. THE EVENT OCCURRED UPON POWER ON AT THE HOSPITAL. THEY NEEDED TO PERFORM TROUBLESHOOTING ON THE DEVICE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22778862 ↗
• MalfunctionAug 11, 2025Device Alarm System; Break; Device Alarm System; Break

  IT WAS REPORTED THAT WHEN THE HEALTH PROFESSIONAL DID THE PRE-TEST AT THE HOSPITAL. THE DEVICE FAILED THE TEST BECAUSE THE FLOAT SWITCH FAILED TO ALARM WHEN DEPRESSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22778636 ↗