UVAR XTSRecalls & reported problems

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 10705030100016), received between Aug 20, 2015 and Apr 27, 2016 — classified as 1 death, 3 injuries, 39 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (20 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 43 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 27, 2016Fogging; Device Displays Incorrect Message; Temperature Problem; Noise, Audible

  CUSTOMER REPORTED A LEAK CENTRIFUGE ALARM JUST BEFORE COLLECTION OF THE BUFFY CODE (BC) IN THE FIRST CYCLE. SHE ALSO STATES THERE WAS AN ABNORMAL SOUND IN THE CENTRIFUGE CHAMBER, IT SEEMED LIKE HEATING UP AND THE GLASS LID WAS FOGGED. TREATMENT WAS ABORTED AND NO BLOOD WAS RETURNED TO THE PATIENT. PATIENT IS IN STABLE CONDITION, NO FURTHER DETAILS WERE PROVIDED. CUSTOMER REQUESTED SERVICE, SERVICE ORDER (SO) WILL BE DISPATCHED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5611311 ↗
• MalfunctionApr 26, 2016Occlusion Within Device; Device Displays Incorrect Message

  CUSTOMER CALLED TO REPORT CENTRIFUGE BLOOD LEAK ALARM DURING TREATMENT PROCEDURE. CUSTOMER STATED THAT NO ONE WAS HURT OR SPLASHED WITH BLOOD/FLUIDS AND THAT THE PATIENT WAS STABLE. CUSTOMER STATED THAT UPON INSPECTION OF THE PARTS, THERE WAS SOME CLOTTING IN THE COLLECT LINE. CUSTOMER STATED THAT THERE WERE MULTIPLE PATIENT OCCLUSION ALARMS, WHICH WERE CLEARED AFTER FLUSHING THE LINE. CUSTOMER STATED THAT UPON OPENING THE CENTRIFUGE LID, THE FLUID WAS LEAKING FROM THE NECK OF THE BOWL. CSS SUGGESTED THAT THE CUSTOMER ABORT THE TREATMENT AND NOT RETURN ANY BLOOD/PRODUCT TO THE PATIENT.

  Patient problems: No Information

  MAUDE report 5607714 ↗
• MalfunctionApr 8, 2016Leak/Splash

  CUSTOMER REPORTED THAT THE FLUID LOGIC MODULE (FLM) LEAKED DURING THE MANUAL RETURN OF BLOOD AFTER THE PROCEDURE. CUSTOMER STATED THAT THE TREATMENT WENT WELL WITHOUT ALARMS OR ISSUE. AFTER THE TREATMENT WAS COMPLETED, THEY DECIDED TO RETURN THE REST OF BLOOD FROM THE KIT MANUALLY TO THE PATIENT. CUSTOMER STATED THAT AS THEY TURNED THE FLM UPSIDE DOWN, THEY DETECTED A LEAK OF BLOOD ON THE RIGHT SIDE OF THE FLM AND THEY DECIDED TO STOP RETURNING THE BLOOD. PATIENT REPORTED AS STABLE. THE CUSTOMER HAS SUBMITTED A PHOTO FOR INVESTIGATION.

  Patient problems: No Information

  MAUDE report 5564012 ↗
• MalfunctionApr 6, 2016Fluid/Blood Leak; Device Displays Incorrect Message; Device Operates Differently Than Expected

  CUSTOMER STATED THAT DURING THE TREATMENT SHE HAD AN OCCLUSION SYSTEM ALARM THAT WAS SOLVED BY FLUSHING THE LINES WITH A SALINE BOLUS. THE SYSTEM THEN POSTED A SYSTEM ERROR 183 ALARM. THE CLINICAL SERVICES SPECIALIST (CSS) ASSISTED CUSTOMER TO CHECK FOR THE PLACEMENT OF THE CENTRIFUGE BOWL AND RESTART IMMEDIATELY. AFTER THE RESTART, A LEAK CENTRIFUGE ALARM WAS POSTED. CSS REQUESTED CUSTOMER TO CLEAN THE SENSOR. CUSTOMER STATED THAT THERE WAS A BLOOD LEAK. CSS REQUESTED CUSTOMER TO ABORT THE TREATMENT AND TO NOT RETURN THE BLOOD TO THE PATIENT. PROCEDURE WAS ABORTED DURING THE 2ND CYCLE OUT OF 6. PATIENT WAS REPORTED AS STABLE. NO PRODUCT WAS RETURNED FOR INVESTIGATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5553127 ↗
• MalfunctionApr 5, 2016Leak/Splash; Device Displays Incorrect Message

  CUSTOMER CALLED TO REPORT THAT DURING PHOTOACTIVATION, IT WAS NOTICED THAT THE PHOTOACTIVATION MODULE WAS LEAKING AT THE UPPER RIGHT CORNER SEAL. CUSTOMER REPORTED 2 BLOOD PUMP ALARMS BEFORE THIS, WHICH PROMPTED CHECKING THE PHOTOACTIVATION CHAMBER. THE PROCEDURE WAS ABORTED AT THIS TIME AND NO BLOOD WAS RETURNED TO THE PATIENT. CUSTOMER REPORTS THAT THE LEAK WAS CONTAINED AND THAT SERVICE WOULD NOT BE NEEDED TO CLEAN THE INSTRUMENT. PATIENT WAS REPORTED AS STABLE. CUSTOMER WILL RETURN PRODUCT FOR INVESTIGATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5548813 ↗
• MalfunctionMar 25, 2016Fluid/Blood Leak

  CUSTOMER CALLED TO REPORT A BLOOD LEAK. CUSTOMER STATED THE BLOOD LEAK OCCURRED ON THE FIRST CYCLE OF TREATMENT. CUSTOMER STATED THEY NOTICED THE CENTRIFUGE BOWL "STARTED TO SOUND FUNNY" AND THE BLOOD LEAK ALARM OCCURRED. CUSTOMER STATED THEY DISCONNECTED THE PATIENT FROM THE TUBING KIT. THE PATIENT IS STABLE AND NOW RECEIVING A NEW TREATMENT. CUSTOMER DECIDED TO NOT RETURN THE KIT OR THE SMART CARD AND HAS ELECTED TO NOT SEND ANY PICTURES. CUSTOMER STATED THE INSTRUMENT WAS NOT DAMAGED AND TECHNICAL SERVICE IS NOT NEEDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5525883 ↗
• MalfunctionMar 17, 2016Leak/Splash

  CUSTOMER REPORTED A CENTRIFUGE BOWL LEAK AT THE UPPER SEAL DURING CYCLE 1. THERAKO'S CLINICAL SERVICES SPECIALIST (CSS) CALLED CUSTOMER BACK TO GATHER FURTHER INFORMATION. CUSTOMER STATED THAT THE PROCEDURE WAS ABORTED AND BLOOD WAS RETURNED MANUALLY TO THE PATIENT. THEN THEY INSTALLED A NEW KIT AND PROCEED NORMALLY THE THERAPY WITHOUT ISSUE. PATIENT REPORTED TO BE IN STABLE CONDITION. NO PRODUCT RETURNED FOR INVESTIGATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5508155 ↗
• MalfunctionMar 16, 2016Device Displays Incorrect Message

  CUSTOMER CALLED TO REPORT F183 ALARM DURING 3RD CYCLE, CUSTOMER STATED THE THUMB SCREW WAS TIGHTLY SCREWED DOWN. CLINICAL SERVICES SPECIALIST (CSS) ADVISED THE CUSTOMER TO POWER THE INSTRUMENT OFF, RELEASE THE BOWL VACUUM, AND VERIFY THE CENTRIFUGE CHAMBER WAS ADEQUATELY GREASED. CUSTOMER STATED HE DID NOT SEE ANY GREASE. CSS ADVISED THE CUSTOMER TO GREASE THE CENTRIFUGE CHUCK AND TO CONTINUE TO GREASE THEIR XTS INSTRUMENT(S) EVERY TWO WEEKS. CUSTOMER CONFIRMED THE CENTRIFUGE BOWL WAS ABLE TO ROTATE AND MOVE EASILY BEFORE PLACING BACK INTO THE CENTRIFUGE CHAMBER. CSS ADVISED THE CUSTOMER TO POWER THE INSTRUMENT BACK ON AND VERIFY THE BOWL HAD A VACUUM SEAL BEFORE CLOSING AND SCREWING THE CENTRIFUGE LID. CUSTOMER RESUMED THE TREATMENT AND A BOWL COVER ALARM OCCURRED, CSS ADVISED THE CUSTOMER TO SCREW THE THUMBSCREW DOWN TIGHTER, CUSTOMER DID AS INSTRUCTED AND RESUMED THE PATIENT TREATMENT WITH A FLOW RATE OF 19ML/MIN. CUSTOMER STATED THEY WOULD CALL BACK IF FURTHER ASSISTANCE WAS REQUIRED. CUSTOMER CALLED BACK ON (B)(6) 2016 TO REPORT THAT THE TOP OF THE BOWL LEAKED AT THE START OF CYCLE 3. CUSTOMER REPORTED THAT NO BLOOD GOT INTO THE INSTRUMENT, SO SERVICE WILL NOT BE REQUIRED. THE

  Patient problems: No Code Available

  MAUDE report 5505518 ↗
• InjuryFeb 24, 2016Insufficient Device Problem Information

  THE PATIENT FAINTED (FOR A DURATION OF APPROXIMATELY 1 MINUTE) WHILE THE CLINICAL SERVICES SPECIALIST (CSS) WAS ON SITE FOR TRAINING. THIS EVENT OCCURED DURING BUFFY COAT IN THE 3RD OF 4 CYCLES. THE PATIENTS BLOOD PRESSURE DROPPED TO 80/50. THE TREATING PHYSICIAN ADMINISTERED 100 ML OF SALINE AND ABOUT 300 ML OF ELECTROLYTE SOLUTION. THE PATIENT WAS BROUGHT INTO A VERTICAL POSITION AND HIS BLOOD PRESSURE STABILIZED. AFTERWARDS, THE PATIENT STATED THAT HE HAD NOT BEEN FEELING WELL ALL WEEK BUT HE HAD NOT MENTIONED THIS WHEN ASKED ABOUT HIS WELL BEING PRIOR TO THE START THE EXTRACORPOREAL PHOTOPHERESIS (ECP) TREATMENT. ECP WAS COMPLETED. THE PATIENT WAS MONITORED FOR SEVERAL HOURS. NO FURTHER EPISODES OCCURRED. DURING CSS FOLLOW UP IT WAS CONFIRMED THAT THE PATIENT REMAINED STABLE AND RECEIVED AN ECP TREATMENT THE NEXT DAY WITHOUT ISSUE.

  Patient problems: Fainting; Low Blood Pressure/ Hypotension

  MAUDE report 5459043 ↗
• MalfunctionFeb 17, 2016Device Alarm System; Leak/Splash

  THE CUSTOMER CALLED TO REPORT A BLOOD LEAK FROM THE FLUID LOGIC MODULE (FLM) WHEN ATTEMPTING TO EMPTY THE CONTENTS OF THE CENTRIFUGE BOWL AND RETURN THE RESIDUAL BLOOD TO THE PATIENT. THE CUSTOMER STATED THAT THE TREATED CELLS AND ALL CONTENTS OF THE RETURN BAG HAD BEEN RETURNED TO THE PATIENT. WHEN THE CUSTOMER WAS ATTEMPTING TO RETURN THE RESIDUAL CELLS IN THE KIT, UPON COMPLETION OF THE TREATMENT PROCEDURE, A BLOOD LEAK WAS NOTED. THEY OPTED NOT TO RETURN ANY RESIDUAL CELLS IN THE KIT. THE CUSTOMER STATED THAT THE PATIENT WAS STABLE. NO ALARMS OCCURRED DURING THE PROCEDURE AND THE ONLY NOTED FLUID LEAK WAS FROM THE FLM. THE CLINICAL SERVICES SPECIALIST OBTAINED CONFIRMATION FROM THE CUSTOMER THAT NO FLUID WAS OBSERVED LEAKING AROUND THE FLM DURING THE PROCEDURE OR WHEN IT WAS REMOVED FROM THE INSTURMENT. THE CUSTOMER HAS AGREED TO RETURN KIT FOR INVESTIGATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 5441873 ↗
• MalfunctionFeb 12, 2016Fluid/Blood Leak; Device Displays Incorrect Message; Packaging Problem

  THE CUSTOMER REPORTED THAT A BLOOD LEAK OCCURRED ON (B)(6) 2016. SHE REPORTED THE KIT HAD COME IN A DAMAGED PACKAGING (SMASHED). THE CUSTOMER DID NOT NOTE ANY ABNORMALITIES OF THE KIT DURING SET UP. THE KIT PRIMED SUCCESSFULLY. FOLLOWING CLARIFICATION WITH THE CUSTOMER BY THE CLINICAL SERVICES SPECIALIST, IT WAS STATED THAT A BLOOD PUMP ALARM OCCURRED AT THE END OF THE THIRD CYCLE AND THE CUSTOMER NOTED A LEAK AT THE BOTTOM OF THE PHOTOACTIVATION MODULE. TREATMENT WAS ABORTED. THE CUSTOMER HAS ELECTED TO NOT RETURN THE KIT FOR INVESTIGATION. SERVICE HAS BEEN REQUESTED.

  Patient problems: Blood Loss

  MAUDE report 5433505 ↗
• MalfunctionFeb 10, 2016Fluid/Blood Leak; Device Displays Incorrect Message

  THE CUSTOMER STATED THAT THE INSTRUMENT POSTED ERROR 530 DURING 1ST CYCLE WHILE TRYING TO COLLECT THE BUFFY COAT. SEVERAL REBOOTS OF THE SYSTEM DID NOT RESOLVE THE ISSUE. THE BLOOD WAS NOT RETURNED TO THE PATIENT. THE PATIENT WAS STABLE. UPDATE 1/15/2016: THE CUSTOMER CALLED BACK AND STATED THAT AFTER UNMOUNTING THE KIT THEY NOTICED A/C FLUID ON THE LAMP SET COMING FROM THE KIT. CSS INQUIRED IF THERE WAS BLOOD OR PLASMA. THE CUSTOMER CONFIRMED IT WAS NEITHER. CUSTOMER STATED THAT THE AMOUNT OF BLOOD NOT RETURNED TO THE PATIENT WAS AROUND 200 ML. UPDATED 1/19/2016: CSS CALLED THE CUSTOMER. THE PATIENT HAD RECEIVED ANOTHER TREATMENT THAT DAY AND WAS FINE. THE CUSTOMER HAD NOTICED A LEAK BETWEEN THE HEMATOCRIT SENSOR AND THE PHOTOACTIVATION MODULE.

  Patient problems: Blood Loss

  MAUDE report 5429159 ↗
• MalfunctionFeb 10, 2016Leak/Splash

  THE CUSTOMER CALLED TO REPORT A BLOOD LEAK ALARM AT THE END OF CYCLE 2 AFTER DRAWING HAD BEEN COMPLETED ON THE XT125 BOWL. THE CUSTOMER STATED THERE WAS NO FLUID IN THE CENTRIFUGE WASTE BAG, NO FLUID VISIBLE ANYWHERE FROM THE KIT AND NO FLUID WAS FELT ON THE KIT. CSS ADVISED THE CUSTOMER TO ABORT THE TREATMENT AND REMOVE THE BOWL FOR FURTHER INSPECTION. THE CUSTOMER STATED THE BOTTOM OF THE BOWL IS INTACT AND THERE IS NO FLUID IN THE CENTRIFUGE CHAMBER. SOME DRIED BLOOD WAS FOUND ON THE TOP OF THE BOWL. CUSTOMER STATED THE PATIENT IS SLEEPING WITH A BLOOD PRESSURE OF 144/70. THE PATIENT WILL BE GIVEN 500ML OF NORMAL SALINE TO REPLACE THE BLOOD LOSS. THE CUSTOMER WILL RETURN THE KIT FOR EVALUATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 5428521 ↗
• MalfunctionFeb 3, 2016Leak/Splash; Device Displays Incorrect Message

  CUSTOMER CALLED TO REPORT A BLOOD LEAK AT THE CENTRIFUGE BOWL INLET LINE WITHIN A COUPLE MINUTES OF STARTING THE PROCEDURE. CUSTOMER REPORTED HAVING MULTIPLE OCCLUSION ALARMS. CUSTOMER DID NOT NOTE IF THEY WERE PATIENT OR SYSTEM OCCLUSION ALARMS. CUSTOMER REPORTED HAVING AN UNKNOWN SYSTEM ERROR DURING PRIME. CUSTOMER FLUSHED THE PATIENT PORT WHICH FLUSHED EASILY. SALINE BOLUS GIVEN WITHOUT ISSUE. CUSTOMER TRIED TO RESUME TREATMENT WHEN BLOOD LEAK ALARM OCCURRED. CUSTOMER REPORTED APPROXIMATELY 2ML LEAK. TREATMENT WAS ABORTED AND NO BLOOD WAS RETURNED TO THE PATIENT. PATIENT WAS REPORTED AS STABLE. THE CUSTOMER ELECTED NOT TO RETURN THE KIT FOR INVESTIGATION. CUSTOMER REQUESTED SERVICE TO CHECK THE INSTRUMENT. (B)(4), WAS GENERATED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 5407432 ↗
• MalfunctionJan 27, 2016Leak/Splash; Device Operates Differently Than Expected

  CUSTOMER CALLED TO REPORT AN OCCLUSION ALARM SHORTLY AFTER STARTING THE FIRST CYCLE. CUSTOMER FOLLOWED TROUBLESHOOTING INSTRUCTIONS PER THE OPERATORS MANUAL AND RESET THE ALARM. SHORTLY AFTER RESETTING THE ALARM, THE CUSTOMER RECEIVED A BLOOD LEAK ALARM AND CONFIRMED THAT BLOOD HAD LEAKED IN THE BOWL. PATIENT WAS DISCONNECTED, THE PROCEDURE WAS ABORTED, AND NO BLOOD WAS RETURNED TO THE PATIENT. CUSTOMER CALLED BACK LATER THAT DAY AND REPORTED THAT THEY TRIED TO PRIME A NEW KIT ON THE SAME INSTRUMENT AND A BLOOD LEAK ALARM OCCURRED. CUSTOMER REQUESTED SERVICE. SERVICE ORDER, (B)(4), WAS DISPATCHED TO CHECK THE INSTRUMENT. UPON FOLLOW-UP FOR RETURN OF THE KIT, THE CUSTOMER STATED THAT THE KIT HAD BEEN ACCIDENTLY DISCARDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5392978 ↗
• MalfunctionJan 22, 2016Fire; Device Emits Odor; Smoking

  THERAKOS TRAINED BIOMEDICAL ENGINEER, CONTRACTED BY THE FACILITY TO PROVIDE INSTRUMENT SERVICE, CALLED TO REPORT THAT THE FACILITY REMOVED THEIR XTS INSTRUMENT FROM SERVICE DUE TO A BURNING SMELL. BIOMED PUT THE INSTRUMENT IN DIAGNOSTIC MODE AND TURNED ON THE LAMPS FOR A WHILE. HE NOTED SMOKE AND THEN A BLUE FLAME ON THE UV LIGHT CABLE GOING TO P4. HE WAS ABLE TO EXTINGUISH THE FLAME WITH A REVERSE VACUUM. THE BIOMED WAS THE ONLY ONE PRESENT DURING THE OCCURRENCE AND STATED HE WAS NOT INJURED. THE BIOMED REQUESTED TO SPEAK WITH THERAKOS TECHNICAL SERVICES REGARDING THE REPAIR AND PARTS. THERAKOS TECHNICAL SERVICE SPOKE WITH THE BIOMED ON 1/5/2016. HE ORDERED REPLACEMENT CABLES TO REPAIR THE INSTRUMENT. THERAKOS TECHNICAL SERVICE SPOKE WITH THE BIOMED AGAIN ON 1/21/2016, HE CONFIRMED THAT HE PLANS TO COMPLETE THE REPAIR TO THIS INSTRUMENT HIMSELF AT THE END OF NEXT WEEK. THERE IS NO REQUEST FOR THERAKOS TO DISPATCH SERVICE. THERAKOS SERVICE ORDER DISPATCH IS NOT NEEDED. THE CUSTOMER HAS AGREED TO RETURN PICTURES FOR INVESTIGATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5385946 ↗
• MalfunctionJan 20, 2016Fluid/Blood Leak

  CUSTOMER CALLED TO REPORT A BLOOD LEAK AT THE COLLECT TUBING WHERE THE COLLECT AND ANTICOAGULANT TUBINGS COME TOGETHER. CUSTOMER STATED THERE WERE NO ALARMS OR COMPLICATIONS WITH PRIME OR THE KIT INSTALLATION. CUSTOMER STATED THE LEAK WAS VISIBLE AS SOON AS BLOOD PASSED THROUGH THE COLLECT TUBING AT THE BIFURCATION OF THE ANTICOAGULANT AND COLLECT TUBINGS. THE CUSTOMER STATED THEY ABORTED THE TREATMENT, REMOVED THE KIT, AND STARTED OVER WITH A NEW KIT. CUSTOMER STATED THE PATIENT WAS STABLE THROUGHOUT THE TREATMENTS. THE CUSTOMER DISCARDED THE KIT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5380996 ↗
• MalfunctionJan 13, 2016Leak/Splash; Leak/Splash

  DISTRIBUTOR REPORTED THAT A USER REPORTED THE FOLLOWING (TRANSLATED FROM SPANISH): "A BLOOD LEAK WAS FOUND IN THE FLUID MODULE LOGIC, AT THE END OF THE TREATMENT WHILE DISMOUNTING THE KIT AND RETURNING THE BLOOD TO THE PATIENT." UPDATE DEC 18, 2015: THE CUSTOMER COMMUNICATED THAT THE CUSTOMER HAS THE HABIT TO DO A MANUAL RETURN OF BLOOD TO THE PATIENT AT THE END OF THE TREATMENT TO PROVIDE ALL THE RED CELLS LEFT TO THE PATIENT. IN THE MOMENT OF STARTING THIS MANUAL RETURN PROCEDURE, THEY DISCOVERED THE LEAK, SO THE MANUAL RETURN WAS NOT PERFORMED. THE PHOTOACTIVATED BUFFY COAT WAS ALL PREVIOUSLY RETURNED TO THE PATIENT CUSTOMER SUBMITTED A VIDEO FOR INVESTIGATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 5363005 ↗
• MalfunctionJan 6, 2016Fluid/Blood Leak

  DURING CERTIFICATION TRAINING, OPERATOR OBSERVED AFTER TREATMENT WAS ENDED, THAT A LEAK AT THE PHOTOACTIVATION MODULE HAD OCCURRED. WHEN RELEASING THE KIT AND OPENING THE PHOTO ACTIVATION CHAMBER, OPERATOR FOUND TREATMENT VOLUME ON THE LOWER GLASS PLATE OF THE PHOTOACTIVATION CHAMBER. NO LEAK WAS OBSERVED DURING TREATMENT. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. THE TREATMENT WAS PERFORMED AND VOLUME WAS RETURNED TO THE PATIENT BEFORE THE OPERATOR BECAME AWARE OF THE LEAK.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5347458 ↗
• MalfunctionJan 4, 2016Fluid/Blood Leak

  WHILE REPORTING A SEPARATE EVENT ((B)(4), 2523595-2015-00320) THE CUSTOMER MENTIONED THAT A FEW WEEKS AGO (DATE UNKNOWN) THERE WAS ALSO A VERY SMALL LEAK IN THE FLUID LEAK MODULE (FLM) OR CLOSE-BY DURING MANUAL BLOOD RETURN. THE PATIENT WAS DISCONNECTED FROM THE INSTRUMENT AT THE TIME AND REPORTED TO BE STABLE AND IN GOOD CONDITION. THE CUSTOMER STATED THAT THEY ROUTINELY ELECT TO PERFORM MANUAL RETURN OF RESIDUAL BLOOD, AFTER DISCONNECTING THE PATIENT FROM THE MACHINE, DUE TO THEIR PATIENT POPULATION. THERE WERE NO ISSUES OR ALARMS DURING THE PROCEDURE. NO ADDITIONAL BLOOD WAS RETURNED AFTER THE LEAK WAS DISCOVERED. NO PRODUCT WILL BE RETURNED AS THE KIT WAS DISCARDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5340414 ↗
• MalfunctionJan 4, 2016Fluid/Blood Leak

  THE CUSTOMER REPORTED A LEAK IN THE FLUID LOGIC MODULE (FLM), OR CLOSE-BY, DURING MANUAL BLOOD RETURN. THE PATIENT WAS DISCONNECTED FROM THE INSTRUMENT AT THE TIME AND REPORTED TO BE STABLE AND IN GOOD CONDITION. THE CUSTOMER STATED THAT THEY ROUTINELY ELECT TO PERFORM MANUAL RETURN OF RESIDUAL BLOOD, AFTER DISCONNECTING THE PATIENT FROM THE INSTRUMENT, DUE TO THEIR PATIENT POPULATION. THERE WERE NO ISSUES OR ALARMS DURING THE PROCEDURE. NO ADDITIONAL BLOOD WAS RETURNED AFTER THE LEAK WAS DISCOVERED. NO PRODUCT WILL BE RETURNED AS THE KIT WAS DISCARDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5340407 ↗
• InjuryDec 22, 2015Adverse Event Without Identified Device or Use Problem

  DURING CELLEX OPERATOR TRAINING, THERAKOS CLINICAL SERVICES SPECIALIST (CSS) WAS ASKED FOR SUPPORT IN A TREATMENT ON THE UVAR XTS. THE OPERATOR REPORTED SYSTEM OCCLUSION ALARM DURING BUFFY COAT COLLECTION IN THE FIRST CYCLE. DURING TROUBLESHOOTING CSS BECOME AWARE THAT OPERATOR HAD CONNECTED THE ANTICOAGULANT TO THE SALINE LINE AND THE SALINE TO THE ANTICOAGULANT LINE. CSS ADVISED TO ABORT TREATMENT WITHOUT RETURNING THE VOLUME TO THE PATIENT. THE TREATMENT WAS ABORTED. THE OPERATOR INSTALLED A NEW KIT AND STARTED A NEW PATIENT TREATMENT. DURING THE FIRST CYCLE OF THE SECOND TREATMENT THE PATIENT WAS FOUND WITH ORTHOSTATIC HYPOTENSION, BLOOD PRESSURE OF 45/33MMHG AND A HEART RATE OF 90/MIN. THE PATIENT COMPLAINED OF NAUSEA AND DIARRHEA. TREATMENT WAS ABORTED AND AS PER PHYSICIAN INSTRUCTION THE PATIENT RECEIVED A 500ML SALINE BOLUS AND ONE VIAL PASPERTIN (METOCLOPRAMID) FOR NAUSEA. THE PATIENT RECEIVED 2 UNITS OF PACKED RED BLOOD CELLS AFTER THE TREATMENT. CSS SUGGESTED TO CHECK PATIENTS LABORATORY VALUES AFTER THE ABORTED TREATMENT AND TO CONSIDER TO PROVIDE THE PATIENT WITH RBC TRANSFUSION BECAUSE OF LOW HCT VALUES. THE RESPONSIBLE PHYSICIAN WAS INFORMED. CSS REVIEWED THE EXTRACO

  Patient problems: Diarrhea; Nausea; Pain

  MAUDE report 5317933 ↗
• MalfunctionDec 21, 2015Fluid/Blood Leak; Decreased Pump Speed; Device Displays Incorrect Message; Maintenance Does Not Comply To Manufacturers Recommendations

  CUSTOMER CALLED TO REPORT SYSTEM ERROR F183: CENTRIFUGE SPEED TOO SLOW, DURING THE BEGINNING OF CYCLE 6. CUSTOMER STATED THEY HAVE CYCLED THE POWER WITHOUT RESOLUTION TO ALARM F183. CUSTOMER CONFIRMED THE THUMBSCREW WAS NOT WOBBLY AND WAS TIGHTLY SCREWED. CSS ADVISED THE CUSTOMER TO UNSCREW THE THUMBSCREW, OPEN THE CENTRIFUGE LID, ENSURE NOTHING WAS BLOCKING THE LID FROM RE-CLOSING AND TIGHTLY RE-SCREW THE THUMBSCREW, TURN THE POWER BACK ON AND RESUME THE TREATMENT. CUSTOMER STATED ANOTHER F183 ALARM OCCURRED, CSS ADVISED THE CUSTOMER TURN THE INSTRUMENT OFF AGAIN, OPEN THE CENTRIFUGE LID, PRESS THE CENTRIFUGE RELEASE BUTTON, AND REMOVE THE CENTRIFUGE BOWL. CUSTOMER STATED THE CENTRIFUGE CHAMBER IS USUALLY GREASED MONTHLY, CSS ADVISED THE CUSTOMER TO GREASE THE CHAMBER EVERY TWO WEEKS AND TO ENSURE ADEQUATE GREASE WAS PRESENT ON THE BOWL CHUCK SEAL, CUSTOMER BEGAN TO ADD SOME GREASE WHEN THEY NOTICED A LEAK COMING FROM THE CENTRIFUGE BOWL ITSELF. CSS ADVISED THE CUSTOMER TO ABORT THE TREATMENT. UPON FOLLOW-UP, THE CUSTOMER STATED THE PATIENT WAS STABLE AND NO MEDICAL INTERVENTION WAS NECESSARY. THE CUSTOMER STATED THEY WILL CALCULATE THE RED CELL LOSS AND DISCUSS THE NEXT STEPS WIT

  Patient problems: Blood Loss

  MAUDE report 5313402 ↗
• MalfunctionDec 18, 2015Leak/Splash; Device Displays Incorrect Message

  CUSTOMER CALLED TO REPORT A BLOOD PUMP ALARM SHORTLY AFTER GOING INTO CYCLE 6. CUSTOMER REPORTED CHECKING THE KIT FOR KINKS AND SAW NONE. CUSTOMER THEN PUSHED THE RESET BUTTON AND RECEIVED ANOTHER BLOOD PUMP ALARM. CUSTOMER THEN NOTICED THAT BLOOD WAS LEAKING FROM THE CENTRIFUGE BOWL SEAL. PROCEDURE ABORTED. CUSTOMER REPORTED THAT THE LEAK WAS ABLE TO BE CLEANED AND SERVICE WOULD NOT BE REQUIRED FOR CLEANING. PATIENT REPORTED AS STABLE. NO PRODUCT WAS RETURNED FOR INVESTIGATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5310783 ↗
• MalfunctionDec 15, 2015Fluid/Blood Leak; Device Displays Incorrect Message

  CUSTOMER CALLED TO REPORT BLOOD PUMP ERRORS DURING THE 6TH CYCLE WHEN EMPTYING THE CHAMBER. CUSTOMER DID TWO SALINE BOLI TO THE PATIENT WITHOUT RESOLUTION PRIOR TO CONTACTING CSS. CSS ASKED THE CUSTOMER TO CHECK FOR CLOTS OR LEAKS. CUSTOMER DID NOT NOTE ANYTHING UNUSUAL. CSS ADVISED THE CUSTOMER TO DO TWO MORE SALINE BOLI AWAY FROM THE PATIENT. CUSTOMER DID AS ADVISED AND ALARM RECURRED. CUSTOMER INSPECTED THE PHOTO CHAMBER AND NOTED LEAKING. TREATMENT ABORTED. PATIENT WAS REPORTED AS STABLE. SERVICE ORDER (B)(4) WAS DISPATCHED. CUSTOMER ELECTED NOT TO RETURN PRODUCT FOR INVESTIGATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5299620 ↗