Spectra Optia® 61000Recalls & reported problems

Summary

The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 05020583610002), received between Jul 24, 2018 and Aug 26, 2026 — classified as 3 deaths, 5 injuries, 41 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (11 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 49 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 26, 2026Break; Fluid/Blood Leak

  Treatment started at 1300. At 1335 fluid leak detector alarmed indicating fluid in centrifuge area. Treatment paused, centrifuge door opened and noted blood leak. Treatment was terminated with EBL "[estimated blood loss]" 185mL. All component of kit were double checked prior to treatment. Upon inspection all components were properly loaded into the machine. Breakage was noted in tubing distal to hexagon lock. Manufacturer was notified of kit malfunction, and information sent per their request. Optia removed from service for deep cleaning and inspection by HTM "[healthcare technology management]"/vendor.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50461860 ↗
• InjuryMar 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PER JOURNAL ARTICLE, ¿EXTRACORPOREAL PHOTOPHERESIS, A THERAPEUTIC ALTERNATIVE FOR T CELL-MEDIATED REJECTION IN RENAL TRANSPLANTATION¿ BY DE LARA GIL ET AL.,T-CELL MEDIATED REJECTION (TCMR) IN RENAL TRANSPLANTATION, ALTHOUGH REDUCED BY BETTER IMMUNOSUPPRESSANTS, STILL IMPACTS GRAFT SURVIVAL. THE ARTICLE STATED THAT ONE WEEKLY CYCLE OF EXTRACORPOREAL PHOTOPHERESIS (ECP) WAS PERFORMED IN THE FIRST MONTH, AND THEN BIWEEKLY. PATIENT 2 UTILIZED A SPECTRA OPTIA DEVICE FOR TREATMENT, HOWEVER ECP WAS DISCONTINUED 3 MONTHS AFTER INITIATION DUE TO PARTIAL THROMBOSIS (BLOOD CLOT) OF THE ARTERIOVENOUS FISTULA (AVF). AFTER ANGIOPLASTY AND THROMBECTOMY, THE AVF WAS PERMEABLE AND THE ECP WAS RESTARTED 5 WEEKS AFTER THE PREVIOUS CYCLE, EVERY 2 WEEKS. TOLERANCE TO THE SESSIONS WAS EXCELLENT WITHOUT ANY SYMPTOMS. THE ONLY COMPLICATION WAS PARTIAL THROMBOSIS OF THE AVF IN PATIENT 2. THERE WERE NO INFECTIONS. THE COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER. THIS WAS A JOURNAL PUBLICATION FROM 2024 TO EVALUATE THE EFFICACY AND SAFETY OF EXTRACORPOREAL PHOTOPHERESIS AS A USEFUL THERAPEUTIC TOOL FOR T CELL-MEDIATED REJECTION IN RENAL TRANSPLANTATION. A REQUEST FOR F

  Patient problems: Thrombosis/Thrombus

  MAUDE report 21595922 ↗
• MalfunctionSep 23, 2024No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information

  THE CUSTOMER REPORTED THAT THE IV POLE ON THE SPECTRA OPTIA EQUIPMENT UNEXPECTEDLY LOWERS DOWN. NO ADVERSE EVENT OCCURRED, AND NO MEDICAL INTERVENTION WAS REQUIRED. NO INJURY WAS REPORTED FOR THIS INCIDENT AND NO PATIENT WAS CONNECTED AT THE TIME THE IV POLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20284406 ↗
• MalfunctionJul 29, 2024Mechanical Problem; Device Slipped; No Apparent Adverse Event; Insufficient Device Problem Information; Mechanical Problem; Device Slipped; No Apparent Adverse Event; Insufficient Device Problem Information

  THE CUSTOMER REPORTED THAT THE IV POLE ON THE SPECTRA OPTIA EQUIPMENT UNEXPECTEDLY LOWERS DOWN. THE IV POLE CLAMP WAS INSTALLED. NO INJURY WAS REPORTED FOR THIS INCIDENT AND NO PATIENT WAS CONNECTED AT THE TIME THE IV POLE WAS SLIDING DOWN, THEREFORE NO PATIENT INFORMATION IS REASONABLY KNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19851432 ↗
• MalfunctionMay 17, 2024Mechanical Problem; Device Slipped; Insufficient Device Problem Information; Mechanical Problem; Device Slipped; Insufficient Device Problem Information

  THE CUSTOMER REPORTED THAT THE IV POLE ON THE SPECTRA OPTIA EQUIPMENT UNEXPECTEDLY LOWERS DOWN. NO ADVERSE EVENT OCCURRED AND NO MEDICAL INTERVENTION WAS REQUIRED. THE IV POLE CLAMP WAS NOT INSTALLED. NO INJURY WAS REPORTED FOR THIS INCIDENT AND NO PATIENT WAS CONNECTED AT THE TIME THE IV POLE WAS SLIDING DOWN, THEREFORE NO PATIENT INFORMATION IS REASONABLY KNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19343501 ↗
• MalfunctionFeb 15, 2024Device Slipped; Insufficient Device Problem Information; Device Slipped; Insufficient Device Problem Information

  THE CUSTOMER REPORTED THAT THE IV POLE ON THE SPECTRA OPTIA EQUIPMENT UNEXPECTEDLY LOWERS DOWN. NO ADVERSE EVENT OCCURRED, AND NO MEDICAL INTERVENTION WAS REQUIRED. THE IV POLE CLAMP WAS NOT INSTALLED AT THE TIME OF THIS EVENT. NO INJURY WAS REPORTED FOR THIS INCIDENT AND NO PATIENT WAS CONNECTED AT THE TIME THE IV POLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18716334 ↗
• MalfunctionFeb 1, 2024Mechanical Problem; Device Slipped; Insufficient Device Problem Information; Mechanical Problem; Device Slipped; Insufficient Device Problem Information

  THE CUSTOMER REPORTED THAT THE IV POLE ON THE SPECTRA OPTIA EQUIPMENT UNEXPECTEDLY LOWERS DOWN. NO INJURY WAS REPORTED FOR THIS INCIDENT AND NO PATIENT WAS CONNECTED AT THE TIME THE IV POLE WAS SLIDING DOWN, THEREFORE NO PATIENT INFORMATION IS REASONABLY KNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18624202 ↗
• MalfunctionJan 11, 2024Mechanical Problem; Device Slipped; Insufficient Device Problem Information; Mechanical Problem; Device Slipped; Insufficient Device Problem Information

  THE CUSTOMER REPORTED THAT THE IV POLE ON THE OPTIA EQUIPMENT UNEXPECTEDLY LOWERS DOWN. NO ADVERSE EVENT OCCURRED AND NO MEDICAL INTERVENTION WAS REQUIRED. THE IV POLE CLAMP WAS NOT INSTALLED NO INJURY WAS REPORTED FOR THIS INCIDENT AND NO PATIENT WAS CONNECTED AT THE TIME THE IV POLE. WAS SLIDING DOWN, THEREFORE NO PATIENT INFORMATION IS REASONABLY KNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18494699 ↗
• MalfunctionAug 14, 2023No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information

  THE CUSTOMER REPORTED THAT THE IV POLE ON THE OPTIA EQUIPMENT UNEXPECTEDLY LOWERS DOWN. NO ADVERSE EVENT OCCURRED AND NO MEDICAL INTERVENTION WAS REQUIRED. NO INJURY WAS REPORTED FOR THIS INCIDENT AND NO PATIENT WAS CONNECTED AT THE TIME THE IV POLE WAS SLIDING DOWN, THEREFORE NO PATIENT INFORMATION IS REASONABLY KNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17546208 ↗
• MalfunctionAug 18, 2022Mechanical Problem; Device Fell; Mechanical Problem

  THE CUSTOMER REPORTED THAT THE IV POLE FALLS EASILY. THERE WAS NOT A PATIENT OR OPERATOR INVOLVED AT THE TIME THE IV POLE FELL, THEREFORE PATIENT INFORMATION IS NOT REASONABLY KNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15250971 ↗
• MalfunctionJul 14, 2022Loose or Intermittent Connection; Mechanical Problem; Device Slipped; Mechanical Problem; Device Slipped

  THE CUSTOMER REPORTED THAT THE IV POLE ON THE SPECTRA OPTIA DEVICE WAS LOOSE. THERE WAS NOT A PATIENT OR OPERATOR INVOLVED AT THE TIME OF THE IV POLE BEING LOOSE, THEREFORE PATIENT INFORMATION IS NOT REASONABLY KNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15016043 ↗
• MalfunctionJun 9, 2022Mechanical Problem; Mechanical Problem; Device Slipped

  THE CUSTOMER REPORTED THAT THE IV POLE WOULD NOT STAY UP. THERE WAS NOT A PATIENT INVOLVED AT THE TIME OF THE IV POLE FALLING, THEREFORE PATIENT INFORMATION IS NOT REASONABLY KNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14645068 ↗
• MalfunctionFeb 25, 2022Device Displays Incorrect Message; No Apparent Adverse Event; No Apparent Adverse Event

  THE CUSTOMER REPORTED SEVERAL APC SPILLOVER WARNINGS DURING A TPE, THE DOCTOR REPORTS AN EVENTUAL HEMOLYSIS. NO PATIENT (DONOR) WAS CONNECTED AT THE TIME OF THE EVENT, THEREFORE, NO PATIENT INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13602089 ↗
• MalfunctionOct 19, 2021No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  THE CUSTOMER REPORTED THAT A STAFF MEMBER USED A LED FLASHLIGHT TO HELP WITH ILLUMINATION WHILE LOOKING THROUGH THE OPTIA VIEW PORT OF THE CENTRIFUGE. THE LED LIGHT REFLECTING BACK FROM THE GLASS PORT, CAUGHT THE STAFF¿ RIGHT EYE, CAUSING VISUAL INJURY. PATIENT WEIGHT IS UNKNOWN AT THIS TIME. PER THE CUSTOMER THE PATIENT IS SEEING THEIR MD AT THIS TIME AND THE OUTCOME IS UNCHANGED.

  Patient problems: Eye Injury

  MAUDE report 12656765 ↗
• MalfunctionJul 23, 2021Mechanical Problem; Device Slipped; Material Twisted/Bent; Unintended Movement; Mechanical Problem; Device Slipped

  THE CUSTOMER REPORTED THAT THE IV POLE ON THE TRIMA EQUIPMENT UNEXPECTEDLY LOWERS DOWN. THE IV POLE WON'T STAY UP & THE HANDLE BAR IN THE BACK IS BENT. NO INJURY WAS REPORTED FOR THIS INCIDENT AND NO PATIENT WAS CONNECTED AT THE TIME THE IV POLE WAS SLIDING DOWN, THEREFORE NO PATIENT INFORMATION IS REASONABLY KNOWN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12217469 ↗
• DeathJul 20, 2021Adverse Event Without Identified Device or Use Problem

  PER A TWEET, A CUSTOMER STATED: "AND ALSO REMEMBER THAT PATIENT WAS PASSED AWAY TRAGICALLY AT THE CHILDREN'S HOSPITAL 1 RIGHT? I THINK THAT WAS SIMPLY TOO TRAGIC BECAUSE I AM HAVE WITNESSED IT WHEN TAKING INTRAVENOUS FUSION ON TERUMO DEVICE THAT I'VE BEEN ALSO KNOWED HOW TO OPERATOR IT THOUGH" THIS REPORT IS BEING FILED DUE TO PATIENT DEATH, ALTHOUGH PER CURRENT INFORMATION THERE IS NO DETECTABLE MALFUNCTION WITH THE TERUMO BCT DEVICE OR ALLEGATION OF A MALFUNCTION. PATIENT INFORMATION AND PROCEDURAL DETAILS ARE UNKNOWN AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 12197452 ↗
• MalfunctionApr 20, 2021Improper or Incorrect Procedure or Method; Inadequate User Interface; Inadequate User Interface

  THE CUSTOMER DECLINED TO PROVIDE THE PATIENT'S ID AND AGE. THE PATIENT'S GENDER WAS OBTAINED FROM THE RDF AND WEIGHT WAS OBTAINED FROM THE DATA SHEET. THE CUSTOMER CONFIRMED THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REQUIRED. CALCULATED BMI: 153.85

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11693625 ↗
• MalfunctionApr 8, 2021Improper Flow or Infusion; Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE OPERATOR INDICATED THAT 'THE AIR WAS ONLY IN THE DRIP CHAMBER. WHEN I STARTED I HAD THE DRIP CHAMBER ¾ WAY FULL AND A FEW HOURS LATER THERE WAS BARELY ANYTHING IN THE DRIP CHAMBER'. SHE CONFIRMED THAT THERE WAS NO CLOTTING, NO MEDICAL INTERVENTION AND NO RETURN LINE AIR DETECTOR (RLAD) ALARMS. PER THE CUSTOMER, THE PATIENT IS TRANSPLANTED AND DOING WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11637436 ↗
• MalfunctionFeb 25, 2021Adverse Event Without Identified Device or Use Problem; Loose or Intermittent Connection; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT WHILE RUNNING A CONTINUOUS MONONUCLEAR CELL (CMNC) COLLECTION PROCEDURE, THEY WERE ABLE TO OPEN THE CENTRIFUGE DOOR OF THE DEVICE WHILE IT WAS STILL SPINNING. THEY WERE ABLE TO CONTINUE AND FINISH THE COLLECTION. THE CUSTOMER REPORTED THERE WERE NO INJURIES TO THE DONOR OR OPERATOR. OPERATOR INFORMATION IS NOT AVAILABLE AT THIS TIME. THE GENDER AND WEIGHT IN A.3 AND A.4 ARE THE DONOR'S INFORMATION AND WERE INCLUDED DUE TO A SYSTEM LIMITATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11380787 ↗
• MalfunctionFeb 19, 2021No Apparent Adverse Event; Device Displays Incorrect Message; No Apparent Adverse Event

  THE CUSTOMER REPORTED THAT DURING A CONTINUOUS MONONUCLEAR CELL COLLECTION (CMNC) PROCEDURE, THEY RECEIVED THE ALARMS 'PATIENT'S FLUID BALANCE MAY BE 10% LOWER THAN REPORTED' AND 'PATIENT'S FLUID BALANCE MAY BE 30% LOWER THAN REPORTED.' PATIENT INFORMATION AND OUTCOME ARE NOT AVAILABLE AT THIS TIME.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11349340 ↗
• MalfunctionFeb 9, 2021Use of Device Problem; Incorrect, Inadequate or Imprecise Result or Readings; Use of Device Problem

  THE CUSTOMER DECLINED TO PROVIDE THE PATIENT'S ID AND AGE. THE CUSTOMER CONFIRMED THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11302310 ↗
• MalfunctionOct 23, 2020Use of Device Problem; Use of Device Problem; Improper or Incorrect Procedure or Method

  AN INTERNAL REVIEW WAS PERFORMED OF RUN DATA FILES TO IDENTIFIED THOSE RUNS IN WHICH AN OPERATOR MAY HAVE INCORRECTLY ENTERED PATIENT DATA, CREATING AN UNREASONABLE BODY MASS INDEX (BMI). THIS EVENT WAS IDENTIFIED DURING THE INTERNAL REVIEW, NOT REPORTED BY THE CUSTOMER, THEREFORE PATIENT INFORMATION, AND OUTCOME ARE NOT AVAILABLE AT THIS TIME. ENTERED WEIGHT OF PATIENT: (B)(6) KG ENTERED HEIGHT OF PATIENT: (B)(6) CM CALCULATED BMI: (B)(6). PROTOCOL PERFORMED: MONONUCLEAR CELL (MNCI).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10726647 ↗
• InjuryOct 9, 2020Use of Device Problem; Inaccurate Flow Rate; Use of Device Problem

  THE CUSTOMER DECLINED TO PROVIDE PATIENT AGE.

  Patient problems: Hemoconcentration

  MAUDE report 10656167 ↗
• MalfunctionAug 26, 2020Gas/Air Leak; Air/Gas in Device; Air/Gas in Device

  DURING A SERVICE CALL FOR "CENTRIFUGE PRESSURE EXCEEDED LIMIT AT THERAPEUTIC PLASMA EXCHANGE PROCEDURE", THE TERUMO BCT SERVICE TECHNICIAN NOTED THAT THE SAMPLE BAG WAS FULL OF AIR AND THERE WERE BUBBLES IN THE PATIENT LINE. THE AC LINE HAD FLUID IN IT AND THE RESERVOIR WAS HALF FILLED. THE CUSTOMER FINISHED THE PROCEDURE AND THE PATIENT WAS DISCONNECTED. THERE WERE NO CONSEQUENCES TO THE PATIENT AND NO MEDICAL INTERVENTION WAS NECESSARY. PATIENT INFORMATION IS NOT AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10454196 ↗
• MalfunctionAug 10, 2020Component Incompatible; Device Handling Problem; Device Handling Problem

  NO ADVERSE CONSEQUENCES TO THE PATIENT WERE REPORTED AND THE PATIENT IS "FINE". PURSUANT TO EU DATA PROTECTION LAWS, THE PATIENT INFORMATION IS NOT AVAILABLE FROM THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10385463 ↗