UVAR XTS XT125Recalls & reported problems

Summary

The FDA's MAUDE database contains 59 adverse event reports that list this exact device (DI 20705030200027), received between May 10, 2016 and Jul 27, 2018 — classified as 1 injury, 58 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (35 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 59 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 27, 2018Obstruction of Flow

  THE CUSTOMER SENT AN EMAIL TO REPORT A BLOOD CLOT OBSERVED DURING THE TREATMENT PROCEDURE. THE CUSTOMER REPORTED THE CLOTS WERE SEEN IN THE RETURN LINE, TREATMENT BAG AND RETURN BAG. THE CUSTOMER REPORTED THE CLOTS WERE OBSERVED DURING THE SECOND CYCLE OF THE PROCEDURE. THE CUSTOMER REPORTED HEPARIN ANTICOAGULANT WAS USED DURING THE TREATMENT AT A 12:1 RATIO. THE CUSTOMER STATED THEY RECEIVED AN OCCLUSION PATIENT ALARM. THE CUSTOMER REPORTED THE PROCEDURE WAS ABORTED WITH NO RETURN OF BLOOD TO THE PATIENT. THE CUSTOMER REPORTED THE PATIENT WAS STABLE. THE CUSTOMER DID NOT RETURN PRODUCT FOR INVESTIGATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7728274 ↗
• MalfunctionJun 6, 2018Device Displays Incorrect Message

  THE CUSTOMER CALLED TO REPORT A SYSTEM ERROR F183 ALARM WAS RECEIVED DURING THE TREATMENT PROCEDURE. THE CUSTOMER STATED THE ALARM WAS RECEIVED BEFORE THE START OF CYCLE 6 OF THE TREATMENT PROCEDURE. THE CUSTOMER STATED THEY OPENED THE CENTRIFUGE CHAMBER TO CHECK FOR LEAKS AND DID NOT SEE ANY. THE CUSTOMER WAS UNABLE TO CLEAR THE ALARM AND ABORTED THE TREATMENT WITHOUT RETURNING BLOOD TO THE PATIENT. THE CUSTOMER STATED THE PATIENT WAS STABLE. THE CUSTOMER HAS RETURNED THE KIT AND DATA KEY FOR INVESTIGATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7576241 ↗
• MalfunctionMay 11, 2018Break; Fluid/Blood Leak; Device Displays Incorrect Message

  THE CUSTOMER SENT AN EMAIL TO REPORT A CENTRIFUGE BOWL LEAK/BREAK DURING THE TREATMENT PROCEDURE. THE CUSTOMER STATED AT THE END OF THE FIRST CYCLE OF THE PROCEDURE THEY RECEIVED A LEAK CENTRIFUGE ALARM. THE CUSTOMER ABORTED THE PROCEDURE AND DID NOT RETURN BLOOD TO THE PATIENT. THE CUSTOMER STATED THE CENTRIFUGE BOWL HAD NO MOVEMENT BETWEEN THE BASE COMPONENT AND BOWL OUTLET. THE CUSTOMER STATED THE PATIENT WOULD START TREATMENT ON A DIFFERENT INSTRUMENT THAT SAME DAY. THE CUSTOMER DID NOT RETURN PRODUCT FOR INVESTIGATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7508822 ↗
• MalfunctionMay 11, 2018Break; Fluid/Blood Leak; Device Displays Incorrect Message

  THE CUSTOMER SENT AN EMAIL TO REPORT A CENTRIFUGE BOWL LEAK/BREAK DURING THE TREATMENT PROCEDURE. THE CUSTOMER STATED AT THE END OF THE FIRST CYCLE OF THE PROCEDURE THEY RECEIVED A LEAK CENTRIFUGE ALARM. THE CUSTOMER ABORTED THE PROCEDURE AND DID NOT RETURN BLOOD TO THE PATIENT. THE CUSTOMER STATED THE CENTRIFUGE BOWL HAD NO MOVEMENT BETWEEN THE BASE COMPONENT AND BOWL OUTLET. THE CUSTOMER STATED THE PATIENT WOULD START TREATMENT ON A DIFFERENT INSTRUMENT THAT SAME DAY. THE CUSTOMER DID NOT RETURN PRODUCT FOR INVESTIGATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7508708 ↗
• MalfunctionMay 10, 2018Break; Fluid/Blood Leak; Device Displays Incorrect Message

  THE CUSTOMER SENT AN EMAIL TO REPORT A CENTRIFUGE BOWL LEAK/BREAK DURING THE TREATMENT PROCEDURE. THE CUSTOMER INDICATED THAT A LEAK CENTRIFUGE ALARM WAS RECEIVED DURING THE RETURN PHASE OF THE FIRST CYCLE DUE TO A CENTRIFUGE BOWL LEAK. THE CUSTOMER ABORTED THE PROCEDURE AND DID NOT RETURN BLOOD TO THE PATIENT. THE CUSTOMER HAS RETURNED PHOTOGRAPHS FOR INVESTIGATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7504631 ↗
• MalfunctionMay 10, 2018Break; Fluid/Blood Leak; Device Displays Incorrect Message

  THE CUSTOMER SENT AN EMAIL TO REPORT A CENTRIFUGE BOWL LEAK/BREAK DURING THE TREATMENT PROCEDURE. THE CUSTOMER STATED DURING THE SECOND CYCLE OF THE PROCEDURE THEY RECEIVED A SYSTEM ERROR F431. THE CUSTOMER STATED UPON INSPECTION OF THE CENTRIFUGE CHAMBER THEY OBSERVED PLASMA LEAKING AT THE LEVEL OF THE CENTRIFUGE BOWL OUTLET LINE. THE CUSTOMER ABORTED THE PROCEDURE AND DID NOT RETURN BLOOD TO THE PATIENT. THE CUSTOMER STATED THE PATIENT WAS STABLE. THE CUSTOMER HAS RETURNED PHOTOGRAPHS FOR INVESTIGATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7504478 ↗
• MalfunctionApr 18, 2018Break; Leak/Splash; Device Displays Incorrect Message

  THE CUSTOMER SENT AN EMAIL TO REPORT A CENTRIFUGE BOWL LEAK/BREAK DURING THE TREATMENT PROCEDURE. THE CUSTOMER STATED THEY RECEIVED A LEAK CENTRIFUGE ALARM AND OPENED THE CENTRIFUGE TO INSPECT FOR LEAKS. THE CUSTOMER STATED THERE WAS A SMALL AMOUNT OF BLOOD AT THE HEAD OF THE CENTRIFUGE BOWL. THE CUSTOMER OBSERVED A LOSS OF MOVEMENT BETWEEN THE FIXED AND ROTATING PART OF THE CENTRIFUGE BOWL. THE CUSTOMER ABORTED THE PROCEDURE AND DID NOT RETURN BLOOD TO THE PATIENT. THE CUSTOMER HAS RETURNED PHOTOGRAPHS FOR INVESTIGATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7441386 ↗
• MalfunctionApr 15, 2018Leak/Splash; Device Displays Incorrect Message

  ON (B)(6) 2018, THE THERAKOS DISTRIBUTOR SUPPORTING THE COUNTRY OF (B)(6) REPORTED THAT ONE OF THEIR CUSTOMERS EXPERIENCED A CENTRIFUGE BOWL LEAK/BREAK WHILE PERFORMING A PATIENT TREATMENT USING AN XTS DEVICE. THE CUSTOMER CONTACTED THE DISTRIBUTOR ON (B)(6) 2018 TO REPORT THAT THEY EXPERIENCED A BLOOD LEAK ALARM DURING THE EXTRACTION PHASE OF THE TREATMENT. THE CUSTOMER ALSO INDICATED THAT THEY HAD OBSERVED BLOOD LEAKING FROM THE NECK OF THE CENTRIFUGE BOWL UPON INSPECTION OF THE XTS KIT. ACCORDING TO THE DISTRIBUTOR, BLOOD FROM THE DEVICE WAS RETURNED TO THE PATIENT. ALTHOUGH REQUESTED, NO FURTHER INFORMATION REGARDING THE INCIDENT WAS PROVIDED. NO PRODUCT WAS RETURNED FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7431908 ↗
• MalfunctionMar 30, 2018Break; Fluid/Blood Leak; Device Displays Incorrect Message

  THE CUSTOMER SENT AN EMAIL TO REPORT A CENTRIFUGE BOWL LEAK/BREAK DURING THE TREATMENT PROCEDURE. THE CUSTOMER REPORTED A LEAK CENTRIFUGE ALARM WAS RECEIVED AND NOTED BLOOD LEAKING FROM THE CENTRIFUGE BOWL. THE CUSTOMER ABORTED THE TREATMENT AND DID NOT RETURN BLOOD TO THE PATIENT. THE CUSTOMER REPORTED THE PATIENT WAS STABLE. THE CUSTOMER HAS RETURNED PHOTOGRAPHS FOR INVESTIGATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7386449 ↗
• MalfunctionMar 16, 2018Break; Leak/Splash; Device Displays Incorrect Message

  THE CUSTOMER SENT AN EMAIL TO REPORT A CENTRIFUGE BOWL LEAK/BREAK DURING THE TREATMENT PROCEDURE. THE CUSTOMER REPORTED A SYSTEM ERROR F404 WAS RECEIVED DURING TREATMENT AND A LEAK CENTRIFUGE ALARM. THE CUSTOMER OBSERVED A LEAK FROM THE CENTRIFUGE BOWL. THE CUSTOMER ABORTED THE TREATMENT AND DID NOT RETURN BLOOD TO THE PATIENT. THE CUSTOMER REPORTED THE PATIENT WAS STABLE. THE CUSTOMER HAS RETURNED PHOTOGRAPHS FOR INVESTIGATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7346640 ↗
• MalfunctionMar 14, 2018Break; Fluid/Blood Leak

  THE CUSTOMER REPORTED A CENTRIFUGE BOWL LEAK/ BREAK THAT OCCURRED DURING A PATIENT TREATMENT. A THIN LINE OF BLOOD WAS DISCOVERED INSIDE THE CENTRIFUGE CHAMBER. THE TREATMENT WAS ENDED AND THE PATIENT WAS DISCONNECTED. THE PATIENT WAS IN STABLE CONDITION AND NOT BE AFFECTED BY THE INCIDENT. THE PATIENT WAS TREATED ON A DIFFERENT INSTRUMENT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE CUSTOMER WILL NOT BE RETURNING THE PRODUCTS BACK FOR INVESTIGATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7337776 ↗
• MalfunctionFeb 16, 2018Break; Fluid/Blood Leak; Device Displays Incorrect Message

  THE CUSTOMER REPORTED A CENTRIFUGE BOWL LEAK/ BREAK THAT OCCURRED DURING A PATIENT TREATMENT. THE BOWL LEAKAGE WAS OBSERVED DURING THE FIRST CYCLE OF THE PROCEDURE. THE CUSTOMER ALSO STATED THAT A SYSTEM ERROR ALARM #: 571 OCCURRED AND THAT THE BOWL SEAL WAS BROKEN. THE CUSTOMER RETURNED PHOTOGRAPHS OF THE INCIDENT TO BE INVESTIGATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7278371 ↗
• MalfunctionFeb 8, 2018Fluid/Blood Leak; Device Displays Incorrect Message

  THE CUSTOMER CALLED TO REPORT A BLOOD LEAK ALARM THAT OCCURRED DURING THE 6TH CYCLE OF A PATIENT TREATMENT. THE CUSTOMER STATED THAT THERE WERE NO ALARMS PRIOR TO THE BLOOD LEAK ALARM. THERE WAS NO BLOOD OBSERVED IN THE CENTRIFUGE CHAMBER AND NO BLOOD WAS SEEN LEAKING FROM ANY PART OF THE KIT. THE TREATMENT WAS ABORTED AND THE PATIENT WAS SAID TO BE IN STABLE CONDITION. THE PATIENT WILL BEGIN A NEW PROCEDURE ON A DIFFERENT INSTRUMENT. THE CUSTOMER HAS RETURNED THE KIT BACK FOR INVESTIGATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7251319 ↗
• MalfunctionFeb 7, 2018Leak/Splash

  CUSTOMER CALLED TO REPORT A CENTRIFUGE BOWL LEAK THAT OCCURRED DURING A PATIENT TREATMENT. THE CUSTOMER STATED THAT PRIOR TO THE CENTRIFUGE BOWL LEAK/ BREAK A LEAK CENTRIFUGE ALARM OCCURRED IN CYCLE 4 DURING THE FINAL BUFFY COAT COLLECTION. THE CUSTOMER SAID THEY THEN NOTICED A SLIGHT SPRAY OF BLOOD IN THE CENTRIFUGE CHAMBER. THE CUSTOMER ABORTED THE PROCEDURE WITH NO BLOOD RETURNED BACK TO THE PATIENT. THE PATIENT WAS SAID TO BE IN STABLE CONDITION AND ASYMPTOMATIC. THE CUSTOMER WILL NOT BE RETURNING ANY PRODUCTS BACK FOR INVESTIGATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7249649 ↗
• MalfunctionFeb 5, 2018Difficult To Position; Device Displays Incorrect Message

  THE CUSTOMER CALLED TO REPORT A SYSTEM ERROR F183 THAT OCCURRED DURING A PATIENT TREATMENT. THE CUSTOMER STATED THAT THE BOWL WAS DIFFICULT TO MANUALLY ROTATE, HOWEVER THE BOWL FIT DIRECTLY INTO THE CENTRIFUGE WITHOUT ANY DIFFICULTIES OR RESISTANCE. PRIMING OF THE KIT WAS COMPLETED SUCCESSFULLY WITHOUT ANY ISSUES OR ALARMS. THE TREATMENT WAS ABORTED AND THE PATIENT WAS SAID TO BE IN STABLE CONDITION. THE CUSTOMER HAS RETURNED THE KIT BACK FOR INVESTIGATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7240520 ↗
• MalfunctionJan 24, 2018Leak/Splash; Device Contamination with Body Fluid

  THE CUSTOMER CALLED TO REPORT A CENTRIFUGE BOWL LEAK DURING THE TREATMENT PROCEDURE. THE CUSTOMER STATED THEY RECEIVED A CENTRIFUGE LEAK ALARM IN CYCLE 5 OF BUFFY COAT COLLECTION. THE CUSTOMER STATED WHEN THE CENTRIFUGE BOWL STOPPED THEY OPENED THE CENTRIFUGE CHAMBER AND FOUND A SMALL AMOUNT OF BLOOD ON THE WALL OF THE CENTRIFUGE CHAMBER. THE CUSTOMER STATED THEY COULD NOT DETERMINE THE SOURCE OF THE LEAK. THE CUSTOMER ABORTED THE TREATMENT AND DID NOT RETURN BLOOD TO THE PATIENT. THE CUSTOMER STATED THE PATIENT WAS STABLE AND DID NOT REQUIRE ANY MEDICAL INTERVENTION, SALINE BOLUS, OR BLOOD TRANSFUSION. THE PATIENT WAS DISCHARGED HOME IN STABLE CONDITION. THE CUSTOMER WILL NOT BE RETURNING PRODUCT FOR INVESTIGATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7216855 ↗
• MalfunctionJan 12, 2018Leak/Splash; Device Displays Incorrect Message

  THE CUSTOMER CALLED TO REPORT A CENTRIFUGE BOWL LEAK/ BREAK THAT OCCURRED DURING A PATIENT TREATMENT. AT THE 6TH CYCLE OF THE PROCEDURE IS WHEN THE INCIDENT WAS SAID TO HAVE OCCURRED. THE CUSTOMER STATED AN OCCLUSION SYSTEM ALARM SOUNDED BUT IT WAS ABLE TO BE RESET AND PROCEDURE COULD CONTINUE. THEN, A SECOND OCCLUSION SYSTEM ALARM SOUNDED AND THE CUSTOMER NOTICED A BLOOD LEAK IN THE CENTRIFUGE CHAMBER. THE PROCEDURE WAS IMMEDIATELY ENDED WITH NO BLOOD OR PRODUCTS RETURNED BACK TO THE PATIENT. THE PATIENT WAS IN STABLE CONDITION AND NOT AFFECTED BY THE INCIDENT. THE CUSTOMER PROVIDED PHOTOGRAPHS TO BE RETURNED FOR INVESTIGATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7187081 ↗
• MalfunctionDec 23, 2017Leak/Splash; Device Displays Incorrect Message

  THE CUSTOMER CALLED TO REPORT A LEAK CENTRIFUGE ALARM AND A TUBING LEAK THAT OCCURRED DURING A TREATMENT PROCEDURE. THE CUSTOMER STATED THAT THE LEAK CENTRIFUGE ALARM OCCURRED IN CYCLE TWO OF SIX DURING THE BUFFY COAT COLLECTION PHASE OF THE TREATMENT PROCEDURE. THE CUSTOMER REPORTED THAT AT THIS POINT, THEY REALIZED THAT THERE WAS A SMALL LEAK (1 TO 2 ML) AT THE NECK OF THE CENTRIFUGE BOWL. THE CUSTOMER STATED THAT THE LEAK ORIGINATED AT THE JOINT WHERE THE FLUID LOGIC MODULE'S TUBING IS ATTACHED TO THE CENTRIFUGE BOWL. THE CUSTOMER REPORTED THAT THEY CLEANED THE LEAK, HOWEVER THE ALARM CONTINUED. THE CUSTOMER STATED THAT THE TREATMENT WAS THEN ABORTED WITH NO RETURN OF BLOOD/PRODUCTS TO THE PATIENT. THE CUSTOMER REPORTED THAT THE PATIENT WAS IN STABLE CONDITION AND WOULD BE ABLE TO TOLERATE THE BLOOD LOSS. THE CUSTOMER STATED THAT THEY WERE PLANNING ON ADMINISTERING A 200 ML FLUID BOLUS TO THE PATIENT AS A PREVENTATIVE MEASURE, PRIOR TO STARTING THE PATIENT ON ANOTHER TREATMENT PROCEDURE THAT SAME DAY. DURING A FOLLOW-UP CALL WITH THE CUSTOMER LATER THAT IN THE DAY, THE CUSTOMER REPORTED THAT THE PATIENT WAS STILL IN STABLE CONDITION AND HAD COMPLETED THE SECOND TREATMENT PROCEDU

  Patient problems: Blood Loss; Fatigue

  MAUDE report 7145201 ↗
• InjuryDec 23, 2017Leak/Splash; Device Displays Incorrect Message

  THE CUSTOMER CALLED TO REPORT A LEAK CENTRIFUGE ALARM AND A TUBING LEAK THAT OCCURRED DURING A TREATMENT PROCEDURE. THE CUSTOMER STATED THAT THE LEAK CENTRIFUGE ALARM OCCURRED IN CYCLE TWO OF SIX DURING THE BUFFY COAT COLLECTION PHASE OF THE TREATMENT PROCEDURE. THE CUSTOMER REPORTED THAT AT THIS POINT, THEY REALIZED THAT THERE WAS A SMALL LEAK (1 TO 2 ML) AT THE NECK OF THE CENTRIFUGE BOWL. THE CUSTOMER STATED THAT THE LEAK ORIGINATED AT THE JOINT WHERE THE FLUID LOGIC MODULE'S TUBING IS ATTACHED TO THE CENTRIFUGE BOWL. THE CUSTOMER REPORTED THAT THEY CLEANED THE LEAK, HOWEVER THE ALARM CONTINUED. THE CUSTOMER STATED THAT THE TREATMENT WAS THEN ABORTED WITH NO RETURN OF BLOOD/PRODUCTS TO THE PATIENT. THE CUSTOMER REPORTED THAT THE PATIENT WAS IN STABLE CONDITION AND WOULD BE ABLE TO TOLERATE THE BLOOD LOSS. THE CUSTOMER STATED THAT THEY WERE PLANNING ON ADMINISTERING A 200ML FLUID BOLUS TO THE PATIENT AS A PREVENTATIVE MEASURE, PRIOR TO STARTING THE PATIENT ON ANOTHER TREATMENT PROCEDURE THAT SAME DAY. DURING A FOLLOW-UP CALL WITH THE CUSTOMER LATER THAT IN THE DAY, THE CUSTOMER REPORTED THAT THE PATIENT WAS STILL IN STABLE CONDITION AND HAD COMPLETED THE SECOND TREATMENT PROCEDUR

  Patient problems: Fatigue; No Information

  MAUDE report 7145200 ↗
• MalfunctionDec 21, 2017Break; Fluid/Blood Leak; Device Displays Incorrect Message

  THE CUSTOMER CALLED TO REPORT A CENTRIFUGE BOWL LEAK/BREAK DURING THE TREATMENT PROCEDURE. THE CUSTOMER STATED DURING CYCLE 6 OF THE PROCEDURE A LEAK CENTRIFUGE ALARM OCCURRED. THE CUSTOMER STATED THEY OPENED THE CENTRIFUGE DOOR TO CHECK FOR MOISTURE AND THE CENTRIFUGE SEEMED DRY. THE CUSTOMER RESTARTED THE PROCEDURE AND RECEIVED ANOTHER LEAK CENTRIFUGE ALARM. THE CUSTOMER STATED THEY STOPPED THE PROCEDURE AND REMOVED THE CENTRIFUGE BOWL, NOTICING THE BLOOD LEAK AT THE BOTTOM OF THE BOWL. THE CUSTOMER STATED THE BLOOD HAD LEAKED ONTO THE BOTTOM OF THE CENTRIFUGE AND CENTRIFUGE WALLS. THE CUSTOMER STATED THE SEAL ON THE CENTRIFUGE BOWL APPEARED TO BE RUPTURED. THE CUSTOMER ABORTED THE TREATMENT AND DID NOT RETURN BLOOD TO THE PATIENT. THE CUSTOMER STATED THE PATIENT WAS STABLE AND RECEIVED A SALINE IV AS A PRECAUTION AS THE PATIENT'S FLUID BALANCE WAS NEGATIVE 500 ML AT THE TIME OF THE LEAK. THE CUSTOMER STATED THE PATIENT DID NOT EXHIBIT ANY SYMPTOMS OR ADVERSE REACTIONS DUE TO THE BLOOD LEAK OR NEGATIVE FLUID BALANCE. THE PATIENT WAS SENT HOME AFTER THE SALINE IV. THE CUSTOMER DID NOT RETURN PRODUCT FOR INVESTIGATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7138890 ↗
• MalfunctionDec 13, 2017Leak/Splash; Device Displays Incorrect Message; Noise, Audible

  THE CUSTOMER CALLED TO REPORT A CENTRIFUGE BOWL LEAK/ BREAK. DURING CYCLE 6 OF THE TREATMENT, THE CUSTOMER HEARD A LOUD NOISE, FOLLOWING THE LOUD NOISE SOUNDED AN OCCLUSION SYSTEM ALARM. THE ALARM WAS SILENCED. FROM THERE A LEAK CENTRIFUGE ALARM HAD OCCURRED, THIS IS WHEN THE BLOOD WAS OBSERVED IN THE CENTRIFUGE AND THE SURROUNDING AREAS. THE TREATMENT WAS ABORTED WITH NO BLOOD RETURNED BACK TO THE PATIENT. THE PATIENT WAS IN STABLE CONDITION AND NOT AFFECTED BY THE INCIDENT. THE CUSTOMER HAS PROVIDED PHOTOGRAPHS TO BE INVESTIGATED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7112875 ↗
• MalfunctionNov 17, 2017Fluid/Blood Leak; Device Displays Incorrect Message

  THE CUSTOMER CALLED TO REPORT A CENTRIFUGE BOWL LEAK/BREAK DURING A TREATMENT PROCEDURE. THE CUSTOMER INDICATED THAT A CENTRIFUGE LEAK ALARM OCCURRED DURING BUFFY COAT COLLECTION OF THE FINAL CYCLE (5 OF 5 CYCLES). THE CUSTOMER ATTEMPTED TO CLEAR THE LEAK ALARM BY CYCLING THE POWER OF THE INSTRUMENT; HOWEVER, A SYSTEM ERROR F183 ALARM SUBSEQUENTLY OCCURRED. THE CUSTOMER OPENED THE CENTRIFUGE CHAMBER DOOR TO INVESTIGATE THE ALARMS AND OBSERVED A SMALL LEAK (LESS THAN 10 ML OF BLOOD) FROM THE SEALS IN THE NECK OF THE CENTRIFUGE BOWL. THE TREATMENT WAS ABORTED AND NO BLOOD OR FLUIDS WERE RETURNED TO THE PATIENT. THE PATIENT WAS REPORTED TO HAVE BEEN IN STABLE CONDITION BEFORE, DURING, AND AFTER THE BLOOD LEAK. THE PATIENT WAS DISCHARGED TO HOME AND WAS SCHEDULED TO RETURN FOR ECP TREATMENT ON (B)(6) 2017. NO PRODUCT WAS RETURNED FOR INVESTIGATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7043224 ↗
• MalfunctionNov 17, 2017Break; Leak/Splash; Device Displays Incorrect Message

  CUSTOMER CALLED TO REPORT A CENTRIFUGE BOWL LEAK/BREAK DURING THE TREATMENT PROCEDURE. THE CUSTOMER STATED A LEAK CENTRIFUGE ALARM OCCURRED DURING TREATMENT AND A THIN STREAK OF BLOOD WAS DISCOVERED ON THE WALL OF THE CENTRIFUGE CHAMBER. THE CUSTOMER ABORTED THE PROCEDURE AND DID NOT RETURN BLOOD TO THE PATIENT. THE CUSTOMER STATED THE PATIENT WAS STABLE. THE CUSTOMER HAS RETURNED A PHOTOGRAPH FOR INVESTIGATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7040238 ↗
• MalfunctionNov 16, 2017Fluid/Blood Leak

  THE CUSTOMER HAD CALLED TO REPORT A CENTRIFUGE LEAK ALARM THAT OCCURRED DURING BUFFY COAT COLLECTION IN THE FINAL CYCLE OF A 4-CYCLE PROCEDURE ON THE XTS INSTRUMENT. THE CUSTOMER WENT ON TO MENTION THAT THERE APPEARED TO BE A FEW DROPLETS BLOOD ON THE CENTRIFUGE LEAK DETECTOR. IN ADDITION, BLOOD DROPLETS WERE REPORTED TO HAVE DRIPPED DOWN FROM THE CENTRIFUGE BOWL SEAL ONTO THE NECK OF THE CENTRIFUGE BOWL.. THE CUSTOMER HAD ABORTED THE PROCEDURE AND DID NOT RETURN ANY BLOOD BACK TO THE PATIENT. THE PATIENT WAS SAID TO BE IN STABLE CONDITION AND WOULD NOT REQUIRE ANY MEDICAL INTERVENTION. THERE WAS NO PRODUCT RETURNED FOR INVESTIGATION, THEREFORE NO FURTHER ACTIONS REQUIRED AT THIS TIME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7038717 ↗
• MalfunctionNov 16, 2017Break; Fluid/Blood Leak

  CUSTOMER CALLED TO REPORT A CENTRIFUGE BOWL LEAK/BREAK DURING THE TREATMENT PROCEDURE. THE CUSTOMER STATED A LEAK CENTRIFUGE ALARM OCCURRED AT THE START OF THE TREATMENT AND A THIN STREAK OF BLOOD WAS DISCOVERED ON THE WALL OF THE CENTRIFUGE CHAMBER. THE CUSTOMER ABORTED THE TREATMENT AND DID NOT RETURN BLOOD TO THE PATIENT. THE CUSTOMER STATED THE PATIENT WAS STABLE. THE CUSTOMER HAS RETURNED A PHOTOGRAPH FOR INVESTIGATION.

  Patient problems: Blood Loss

  MAUDE report 7037957 ↗