NA ATL2001 (UDI 00613994520456)Recalls & reported problems

Summary

The FDA's MAUDE database contains 79 adverse event reports that list this exact device (DI 00613994520456), received between Jan 20, 2020 and Mar 2, 2026 — classified as 1 death, 14 injuries, 64 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (56 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 79 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 2, 2026Device Alarm System; Break; Noise, Audible

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF THE AUTOLOG WASH KIT, IT WAS REPORTED THAT THE CENTRIFUGAL BOWL OVERHEATED, SENT AN ERROR AND BROKE. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT IT DOES NOT APPEAR AS THOUGH THE FINS WERE DAMAGED. THERE WAS NO LEAK MENTIONED, BUT A GRINDING NOISE WAS REPORTED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CUSTOMER IS NOT SURE THERE WAS OVERHEATING, JUST A GRINDING NOISE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24481827 ↗
• MalfunctionDec 8, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING AN AUTOLOGOUS BLOOD RECOVERY PROCEDURE, THE AUTOLOG WASHKIT WAS OBSERVED TO BE LEAKING WATER. THE ANESTHESIA NURSE DISCOVERED WATER LEAKAGE AT THE BOTTOM OF THE DEVICE, AND UPON INSPECTION, IT WAS DETERMINED THAT THE LEAK ORIGINATED FROM THE TOP OF THE DEVICE. THE DEVICE WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23741044 ↗
• MalfunctionDec 2, 2025Device Alarm System; Obstruction of Flow; Material Deformation; Device Alarm System; Obstruction of Flow; Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE AUTOLOG WASHKIT, THE DEVICE WAS OBSERVED NOT TO BE ROTATING AFTER SETUP. THE INITIAL MACHINE ALARM INDICATED "AIR IN SALINE," PROMPTING A CHECK OF THE TUBING AND CLAMPS, WITH NO ISSUES FOUND IN THE SETUP. SUBSEQUENT MACHINE ALARMS INCLUDED "OPTICS OBSTRUCTED" AND "ERROR CENTRI SPEED." THE CONSUMABLE WAS TRANSFERRED TO ANOTHER MACHINE FOR TROUBLESHOOTING, BUT THE KIT STILL DID NOT ROTATE. A NEW KIT WAS SET UP IN THE FIRST MACHINE AND FUNCTIONED PROPERLY. UPON INSPECTION OF THE ORIGINAL KIT, AN OBSTRUCTION WAS FELT INSIDE THE BOWL. THE LINES AND TUBING WERE CUT TO DRAIN THE BLOOD FROM THE BOWL AND CLEAN IT. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CELL SAVER WAS SET UP IN THE MORNING BUT IT WAS NOT UTILIZED. IT WAS ENDORSED FOR LATER USE. THE CUSTOMER USED THE ALREADY PREPARED CELL SAVER IN THE AFTERNOON FOR THE RE-OPERATION CASE OF DR. (B)(6) SINCE THE PATIENT STILL BLED DESPITE HEMOSTATIC INTERVENTION AFTER CABG (CORONARY ARTERY BYPASS GRAFTING) MVR (MITRAL VALVE REPAIR OR REPLACEMENT) SURGERY. THEY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23693241 ↗
• MalfunctionDec 1, 2025Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN AUTOLOG WASHKIT, IT WAS REPORTED THAT THE BOWL WAS RUPTURED. BLOOD LEAKAGE WAS OBSERVED THROUGH THE WALLS OF THE BOWL. THE PROCEDURE WAS AN AORTIC VALVE REPLACEMENT SURGICAL PROCEDURE. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23678611 ↗
• MalfunctionNov 11, 2025Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF AN AUTOLOG WASH KIT, IT WAS REPORTED THAT AFTER THE CIRCUIT WAS ASSEMBLED AND CONNECTED FOR TESTING, A LEAK WAS NOTICED THROUGH THE INSTRUMENT¿S DRAIN. SINCE THE LEAK OCCURRED DURING THE EQUIPMENT TESTING PHASE, THE MATERIAL WAS NOT CONTAMINATED, AS ONLY SALINE SOLUTION WAS BEING USED. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE LEAK OCCURRED IN THE CENTRIFUGAL BOWL. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WAS NO DAMAGE OBSERVED TO THE INSTRUMENT OR DISPOSABLE. THERE WERE NO AUDIBLE OR PERFORMANCE ABNORMALITIES. AS THE LEAK OCCURRED AT THE BEGINNING, THE BAG HADN'T EVEN BEEN FILLED YET. AN ERROR WARNING MESSAGE DID NOT APPEAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23522596 ↗
• MalfunctionOct 23, 2025Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF AN AUTOLOG WASHKIT, IT WAS REPORTED THAT WHEN THE CIRCUIT WAS PRIMED IN PREPARATION FOR USE, WATER LEAKED AND THE DEVICE COULD NOT BE USED. THE DEVICE WAS REPLACED. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23367058 ↗
• MalfunctionOct 16, 2025Fluid/Blood Leak; Noise, Audible; Fluid/Blood Leak; Noise, Audible

  IT WAS REPORTED THAT DURING THE PREPARATION AND FILLING PROCEDURE WITH THE AUTOLOG WASHKIT, THE PRODUCT DID NOT REACH FULL VOLUME AND DID NOT SPIN PROPERLY INSIDE THE CENTRIFUGE, WHICH PRODUCED AN UNUSUAL NOISE DURING USE. LEAKAGE AND OVERFLOW WERE OBSERVED INSIDE THE CENTRIFUGE. THE PROCEDURE WAS INTERRUPTED, AND THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23309735 ↗
• MalfunctionSep 15, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING USE OF THE AUTOLOG WASHKIT, A SMALL AMOUNT OF BLOOD WAS OBSERVED DRIPPING FROM THE BOTTOM OF THE AUTOLOG INSTRUMENT, AND UPON DISASSEMBLY OF THE BOWL FROM THE CENTRIFUGE WELL AT THE END OF THE SURGICAL PROCEDURE, BLOOD WAS OBSERVED SPILLED INSIDE THE WELL. PATIENT BLOOD LOSS OCCURRED DUE TO THIS ISSUE. THE LEAK WAS NOT NOTICED UNTIL THE SURGERY WAS ALMOST FINISHED. NO ERROR OR WARNING MESSAGES APPEARED, AND THERE WERE NO AUDIBLE OR PERFORMANCE ABNORMALITIES REPORTED. THE BOWL OR TUBING WAS NOT RE-SEATED, REINSTALLED, OR REPLACED. NO DAMAGE WAS NOTED ON THE INSTRUMENT OR DISPOSABLE, AND NO BLOOD WAS DISCARDED. THE PATIENT DID NOT REQUIRE AN UNPLANNED TRANSFUSION. THE DEVICE WAS USED TO COMPLETE THE PROCEDURE AS NO ADDITIONAL BLOOD LOSS WAS ANTICIPATED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23052054 ↗
• MalfunctionSep 10, 2025Material Puncture/Hole; Material Puncture/Hole

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN AUTOLOG WASH KIT AND A SUCTION ANTICOAGULANT ASSEMBLY, IT WAS REPORTED THAT AFTER INSTALLING THE CENTRIFUGE CUP, THE LIGHT DID NOT LIGHT UP AND THE ALARM SOUNDED. THE CENTRIFUGE CUP COULD NOT OPERATE. THE CUSTOMER UNSCREWED THE CENTRIFUGE CUP AND FOUND THAT THE SIDE PARTS OF THE CUP BODY HAD FALLEN OFF. AT THE SAME TIME, THE SUCTION ANTICOAGULANT ASSEMBLY USED IN CONJUNCTION WITH IT HAD BEEN CONTAMINATED. SEE ATTACHED PHOTOS. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23015064 ↗
• MalfunctionAug 27, 2025Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN AUTOLOG WASHKIT, IT WAS REPORTED THAT THE CIRCUIT WAS ASSEMBLED AND CONNECTED TO THE MACHINE WHICH WASHES THE CIRCUIT AND REMOVES THE AIR FROM THE LINE. SHORTLY AFTER THE CYCLE STARTED, IT WAS NOTICED THAT THE DRAIN AT THE BOTTOM OF THE MACHINE BEGAN FLOODING THE FLOOR. THE CENTRIFUGE BOWL WAS REMOVED AND IT WAS VERIFIED THAT THE BOWL ITSELF WAS LEAKING. THE BOWL WAS COMPLETELY FULL. THE BOWL DID NOT RUN A CYCLE SINCE IT WAS THE BEGINNING OF THE SURGERY AND THERE WERE NOT ENOUGH RED BLOOD CELLS. THE LEAKAGE OCCURRED EXCLUSIVELY WITH SALINE. THE RESERVOIR HAD ALREADY CONTAINED BLOOD, HOWEVER, THE BOWL WAS NOT YET CONTAMINATED AS IT WAS STILL IN THE FILLING STAGE. THE BLOOD IN THE RESERVOIR WAS NOT DISCARDED. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22902263 ↗
• MalfunctionAug 8, 2025Fluid/Blood Leak; Material Deformation; Fluid/Blood Leak; Material Deformation

  IT WAS REPORTED THAT AN AUTOLOG WASHKIT WAS ALLEGED TO HAVE A BROKEN BELL, RESULTING IN BLOOD LOSS DURING USE. THE USE OF THE DEVICE WAS UNSPECIFIED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22748192 ↗
• MalfunctionAug 8, 2025Fluid/Blood Leak; Material Deformation; Fluid/Blood Leak; Material Deformation

  IT WAS REPORTED THAT DURING USE OF THE AUTOLOG WASH KIT, AN ALLEGED PRODUCT ISSUE OCCURRED IN WHICH THE BELL WAS BROKEN AND BLOOD WAS LOST. THE USE OF THE DEVICE WAS UNSPECIFIED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22748102 ↗
• MalfunctionAug 8, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING USE OF AN AUTOLOG WASHKIT, THE BLOOD CONTENT IS LOST FROM THE BELL/BOWL. THE USE OF THE DEVICE WAS UNSPECIFIED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22747123 ↗
• MalfunctionJul 23, 2025Device Alarm System; Device Alarm System

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN AUTOLOG WASH KIT, IT WAS REPORTED THAT ERROR MESSAGES APPEARED. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22574090 ↗
• MalfunctionJul 10, 2025Break; Break

  MEDTRONIC RECEIVED INFORMATION THAT AFTER THE USE OF AN AUTOLOG WASH KIT, IT WAS REPORTED THAT AT THE END OF THE PROCEDURE, WHEN THE CUSTOMER HAD SPUN DOWN ALL THEIR BLOOD, THEY UNLOCKED THE CENTRIFUGAL BOWL FROM THE CENTRIFUGE AND ATTEMPTED TO PULL THE BOWL OUT OF THE CENTRIFUGE AND THE TOP OF THE BOWL CAME OFF. THE REMAINDER OF THE BOWL STAYED IN THE CENTRIFUGE. THERE WAS NO INDICATION OF AN ISSUE WHILE THEY WERE RUNNING THE CELL SAVER. THE ISSUE OCCURRED AFTER THE PROCEDURE DURING TEAR DOWN. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE BOWL FINS WERE NOT DAMAGED. THERE WAS NO DAMAGE TO THE PACKAGING (OUTER BOX, INNER PACKAGING OR STERILE BARRIER). OTHER DEVICES IN THE SAME BOX/SHIPPING CONTAINER WERE NOT DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22466771 ↗
• MalfunctionJul 1, 2025Fluid/Blood Leak; Mechanical Problem; Fluid/Blood Leak; Mechanical Problem

  IT WAS REPORTED THAT DURING USE OF THE WASH KIT, A LEAK AND SPILL OCCURRED DUE TO A CRACKED BOWL THAT DEVELOPED SHORTLY AFTER FILLING, RESULTING IN PATIENT BLOOD LOSS AND A WASHED BLOOD ISSUE. THE ISSUE TOOK PLACE DURING THE FILLING OF THE BOWL. THE DISPOSABLE BOWL WAS REPLACED, AND THE CASE PROCEEDED NORMALLY WITH THE NEW BOWL FUNCTIONING AS EXPECTED. NO UNPLANNED TRANSFUSION WAS REQUIRED, AND NO BLOOD WAS DISCARDED BECAUSE OF THE ISSUE. NO ERROR OR WARNING MESSAGES APPEARED, AND THERE WERE NO VISUAL, AUDIBLE, OR PERFORMANCE ABNORMALITIES ASIDE FROM THE CRACKED BOWL. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.'

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22369281 ↗
• MalfunctionJun 30, 2025Crack; Fluid/Blood Leak; Material Deformation; Crack; Fluid/Blood Leak; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN AUTOLOG WASH KIT DEVICE, IT WAS REPORTED THAT THE DEVICE HAD A CRACKED BOWL AND LEAKED BLOOD. THERE WAS NO INFORMATION ON THE AMOUNT OF BLOOD LOST, BUT IT WAS NOT ENOUGH TO REQUIRE A BLOOD TRANSFUSION. ISSUE OCCURRED DURING FILLING THE BOWL, NO ERROR WARNING MESSAGE. THERE WERE NO VISUAL, AUDIBLE OR PERFORMANCE ABNORMALITIES, AND NO BLOOD WAS DISCARDED BECAUSE OF THIS ISSUE. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22359168 ↗
• MalfunctionJun 18, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT DURING AN AUTOLOGOUS BLOOD TRANSFUSION PROCEDURE USING THE AUTOLOG WASHKIT, BLOOD CLOTS WERE OBSERVED IN THE TUBING AFTER BLOOD FROM THE CLEANED BLOOD BAG HAD BEEN TRANSFUSED BACK INTO THE PATIENT FOR A PERIOD OF TIME. THE TUBING BECAME BLOCKED DUE TO THE PRESENCE OF BLOOD CLOTS. THE PATIENT HAD A HISTORY OF LUMBAR SPINE DISEASE. TO AVOID RISK TO THE PATIENT¿S LIFE, THE OPERATING ROOM NURSE OPENED A DEVICE AND RE-CLEANED THE ORIGINAL BLOOD BAG BEFORE RETRANSFUSING THE BLOOD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WAS BLOOD SENT TO THE WASTE BAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22282916 ↗
• MalfunctionMay 28, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING A CARDIAC REVASCULARIZATION PROCEDURE, AN AUTOLOG WASH KIT WAS FOUND TO BE LEAKING SALINE SOLUTION. THE DEVICE ARRIVED IN ITS ORIGINAL SEALED BOX AND WAS INSTALLED WITHOUT ANY INITIAL PROBLEMS. HOWEVER, UPON FILLING THE DEVICE WITH SALINE SOLUTION, A LEAK WAS OBSERVED FROM ONE SIDE. DESPITE NO ALERTS BEING DISPLAYED ON THE SCREEN, THE LEAK INCREASED WHEN THE PROCESS BEGAN, LEADING TO THE DISCONTINUATION OF THE DEVICE'S USE. THE PHYSICIAN DECIDED TO TERMINATE THE PROCEDURE WITHOUT REPLACING THE DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE LEAK WAS OBSERVED COMING ONLY FROM THE WASH KIT. THERE WAS NO DAMAGE NOTED IN THE INSTRUMENT OR THE DISPOSABLE. THERE WAS NO VISUAL, AUDIBLE, OR PERFORMANCE ABNORMALITIES. THE BOWL OR TUBING WAS NOT RE-SEATED/REIN STALLED/REPLACED. THE FILL (FLUID) LEVEL OF THE RESERVOIR, HOLDING, SALINE, AND WASTE BAG AT THE TIME OF THE ISSUE WAS 250CC. THERE WAS NO BLOOD LEAK. THE DEVICE LEAKED SALINE SOLUTION WHEN PURGING THE EQUIPMENT, THEREFORE, THERE WAS NO BLOOD LOSS IN THE EQUIPMENT. NO TRANSFUSION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22094416 ↗
• MalfunctionApr 29, 2025Device Alarm System; Fluid/Blood Leak; Air/Gas in Device; Device Alarm System; Fluid/Blood Leak; Air/Gas in Device

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF AN AUTOLOG WASH KIT, IT WAS REPORTED THAT THERE WAS A FLUID LEAK FROM THE WASH SET. THE LEAK OCCURRED DURING PRIMING WITH NO BLOOD INVOLVED. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WAS NO DAMAGE NOTED IN THE INSTRUMENT OR THE DISPOSABLE. THERE WAS NO VISUAL, AUDIBLE, OR PERFORMANCE ABNORMALITIES. THE BOWL LEAKED FLUID AT THE BACK AND UNDERNEATH THE MACHINE. APPROXIMATELY 400ML OF SALINE WAS RUN THROUGH THE DEVICE. AN ERROR WARNING MESSAGE APPEARED STATING THAT THERE WAS AIR IN LINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21924766 ↗
• MalfunctionApr 9, 2025Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF AN AUTOLOG WASHKIT, A SALINE SOLUTION WAS OBSERVED LEAKING FROM THE BELL. THE CUSTOMER OBSERVED THAT THE DEVICE BOX WAS SEALED, AND THE BELL WAS INSERTED SMOOTHLY INTO THE DEVICE. HOWEVER, UPON INITIATING THE SALINE FLUSH, THE LEAKAGE WAS DETECTED. THE CUSTOMER STATED THAT WHEN THEY WENT TO INSTALL THE HOOD, IT APPARENTLY HAD NO STRUCTURAL MODIFICATIONS, AND THAT IT HAD NOT BEEN HIT OR FORCIBLE INSERTED. THE BELL WAS REPLACED WITH ANOTHER ONE, WHICH FUNCTIONED WITHOUT ISSUES. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WAS NO DAMAGE NOTED IN THE INSTRUMENT OR THE DISPOSABLE. THERE WAS NO VISUAL, AUDIBLE, OR PERFORMANCE ABNORMALITIES. THE PURGING PROCESS WAS JUST BEGINNING, WITH A 250CC SALINE TANK INSTALLED. THERE WAS STILL NOTHING IN THE WASTE BAG. AN ERROR WARNING MESSAGE DID NOT APPEAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21804086 ↗
• MalfunctionApr 2, 2025Material Deformation; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF AN AUTOLOG WASH KIT, IT WAS REPORTED THAT THE HEAD PART OF THE BOWL WAS DISRUPTED FROM ROTATION AND WAS BROKEN. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21754655 ↗
• MalfunctionMar 20, 2025Obstruction of Flow; Obstruction of Flow

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN AUTOLOG WASHKIT DEVICE, IT WAS REPORTED THAT BLOOD CLOTS APPEARED IN THE PIPELINE. SEE ATTACHED PHOTOS. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21650708 ↗
• MalfunctionMar 10, 2025Material Deformation; Noise, Audible; Material Deformation; Noise, Audible

  IT WAS REPORTED THAT THE AUTOLOG WASH KIT PRODUCED A RATTLING NOISE, SIMILAR TO AN IMPROPERLY FITTED WASHER KIT PRIOR TO USE. THE ISSUE PERSISTED EVEN AFTER REINSTALLATION. AFTER DRAINING THE RESERVOIR AND RUNNING THE AUTOLOG AGAIN, SMOKE WAS OBSERVED. SUBSEQUENTLY, AFTER OPERATING THE PUMP, WHITE CRYSTALLINE DEPOSITS WERE FOUND ON THE PUMP. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WAS NO DAMAGE NOTED IN THE INSTRUMENT OR THE DISPOSABLE. AN ERROR WARNING MESSAGE DID NOT APPEAR. ALTHOUGH AN ISSUE WAS IDENTIFIED PRIOR TO USE, DUE TO EMERGENCY SITUATION, THE CUSTOMER WAS UNABLE TO REPLACE THE PRODUCT IMMEDIATELY. AFTER BRIEFLY RUNNING THE PUMP, THE ISSUE PERSISTED, AND THE PRODUCT WAS SUBSEQUENTLY REPLACED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT INITIALLY, A WHITE FOREIGN SUBSTANCE WAS REPORTED. HOWEVER, IT WAS EXPECTED THAT THE PRODUCT'S SHAFT COLLAPSED, CAUSING THE MATERIAL TO BE SHAVED OFF. THEREFORE, THE CUSTOMER CONFIRMED THAT THIS WAS NOT A CASE OF A FOREIGN SUBSTANCE. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THEY COULD NOT INSPECT THE PRODUCT DIRECTLY TO CONFIRM WHETHER A CRACK/LEAK WAS OBSERVED O

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21558100 ↗
• MalfunctionMar 3, 2025Break; Fluid/Blood Leak; Noise, Audible; Break; Fluid/Blood Leak; Noise, Audible

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF THE AUTOLOG WASH KITS, IT WAS REPORTED THAT THE CUSTOMER NOTED THE CENTRIFUGE BOWLS WERE DAMAGED AND BLOOD HAD LEAKED TO THE INSTRUMENT AND THE GROUND. THE DEVICES WERE REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADDITIONAL ADVERSE PATIENT EFFECT BECAUSE OF THESE ISSUES. THE CUSTOMER ALSO STATED THAT THE PATIENT'S ANATOMY WAS NOT THE CAUSE OF THIS PROBLEM. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE INSTRUMENT HAD NOT BEEN DAMAGED YET, BUT IT HAD BEEN IN USE FOR MORE THAN FIVE YEARS AND WAS OPERATING AT FULL CAPACITY IN THE DEPARTMENT. THERE WAS VISUAL, AUDIBLE, AND PERFORMANCE ABNORMALITIES NOTED. DURING THE USE OF THE WASH KITS, THE SOUND WAS LOUDER THAN BEFORE. DURING THE CYCLE, THE PROBLEM OCCURRED WHEN THE FIRST CENTRIFUGAL BOWL WAS FIRST CLEANED. THE CLEANING KIT WAS REPLACED AFTER THE PROBLEM WAS FOUND. THE ISSUE OCCURRED WITH AN UNKNOWN FILL LEVEL, AND THERE WAS NO ERROR MESSAGE, ONLY THE CENTRIFUGE BOWL WAS FOUND TO BE BROKEN. TIMELY DETECTION OF THE LEAK MEANT THAT NO ADDITIONAL TRANSFUSION OF ALLOGENEIC BLOOD WAS REQUIRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT AT PRESENT, THE INSTRUMENT IS RUNNING NOR

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21504614 ↗