Rika Plasma Donation System 42000Recalls & reported problems

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 05020583420007), received between Nov 30, 2023 and Mar 24, 2026 — classified as 1 death, 39 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (40 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 40 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 24, 2026No Apparent Adverse Event; Insufficient Device Problem Information

  CUSTOMER REPORTED HEMOLYSIS. PATIENT INFORMATION AND OUTCOME ARE UNKNOWN AT THIS TIME.

  Patient problems: Hemolysis

  MAUDE report 24675433 ↗
• MalfunctionMar 19, 2026Fire; Device Difficult to Maintain; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING EQUIPMENT REQUIRED MAINTENANCE, UPON INSPECTION THE TECHNICIAN REPORTED SEEING A FLAME ON THE MULTIFUNCTION CCA WHILE SERVICING THE DEVICE. TECHNICIAN/PATIENT AGE AND WEIGHT WERE NOT PROVIDED. IT WAS REPORTED THAT THERE WAS NO SERIOUS INJURY OR MEDICAL INTERVENTION.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24640905 ↗
• MalfunctionMar 4, 2026No Apparent Adverse Event; Insufficient Device Problem Information

  THE CUSTOMER REPORTED POTENTIAL HEMOLYSIS. PATIENT INFORMATION IS UNKNOWN AT THIS TIME. NO INJURY OR MEDICAL INTERVENTION WERE REQUIRED FOR THIS EVENT.

  Patient problems: Hemolysis; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24505948 ↗
• MalfunctionJan 5, 2026No Apparent Adverse Event; Insufficient Device Problem Information

  CUSTOMER REPORTED POTENTIAL HEMOLYSIS. PATIENT INFORMATION AND OUTCOME ARE UNKNOWN AT THIS TIME.

  Patient problems: Hemolysis; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23960075 ↗
• MalfunctionJan 2, 2026No Apparent Adverse Event; Insufficient Device Problem Information

  CUSTOMER REPORTED THAT THE DEVICE ALARMED (4403 POTENTIAL RBC SPILLOVER DETECT AND 4402 POTENTIAL HEMOLYSIS DETECT) AND THE DONATION WAS ENDED. AFTER LETTING THE SAMPLES SET FOR AN HOUR, THE HEMOLYSIS WAS IDENTIFIED IN THE TEST TUBE AND COLLECTION LINE OF THE RIKA BOTTLE. THE PLASMA WAS AN ORANGE-RED COLOR IN THE BOTTLE AT THE END OF THE DONATIONS AND THE TUBING LEADING TO THE BOTTLE WAS A DARK RED COLOR. ANTICOAGULANT AND SALINE WERE CONNECTED TO THE COLLECTION SETUP AND BOTH SOLUTIONS WERE CORRECTLY ATTACHED. PER CUSTOMER "THE DONOR WAS MONITORED FOR 15 MINUTES DUE TO THE CELL LOSS (THE RINSEBACK COULD NOT BE PERFORMED). THE DONOR DID NOT EXPERIENCE ANY ADVERSE EVENTS FROM THE POTENTIAL HEMOLYSIS OR CELL LOSS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23945948 ↗
• MalfunctionDec 15, 2025No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information

  THE CUSTOMER REPORTED SUSPECTED HEMOLYSIS. DONOR INFORMATION AND OUTCOME ARE NOT AVAILABLE AT THIS TIME.

  Patient problems: Hemolysis

  MAUDE report 23805983 ↗
• MalfunctionOct 9, 2025No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information

  THE CUSTOMER ALLEGED POTENTIAL FOR SERIOUS INJURY, BUT DID NOT PROVIDE ADDITIONAL DETAILS FOR THIS EVENT. PATIENT INFORMATION AND OUTCOME ARE UNKNOWN AT THIS TIME.

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

  MAUDE report 23256164 ↗
• MalfunctionSep 12, 2025No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information

  THE CUSTOMER REPORTED THAT THEY OBSERVED POSSIBLE (RED BLOOD CELL) RBC SPILLOVER. RBCS REACHED THE PLASMA LINE WITHOUT ANY ALARMS OCCURRING. WHEN THE CUSTOMER INSPECTED THE PLASMA LINE IT WAS NOTED THAT THE RBCS AND PLASMA IN THE PLASMA LINE LOOKED CONGEALED. THERE WERE NO ISSUES NOTED IN SETUP DURING SETUP INVESTIGATION AND THE SOLUTIONS WERE SPIKED CORRECTLY. FULL PATIENT IDENTIFIER: (B)(6) PER CUSTOMER "DONOR WAS OKAY AT THE TIME OF RELEASE AND HAS DONATED SINCE" THE COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23038529 ↗
• DeathJul 8, 2025No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information

  THE CUSTOMER REPORTED A DONOR DEATH WITHIN 36 HOURS OF DONATING. PATIENT INFORMATION IS UNKNOWN AT THIS TIME. 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 problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22438243 ↗
• MalfunctionJun 26, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THE CUSTOMER REPORTED THAT THE MACHINE ALLOWED AIR BUBBLES TO FLOW BACK TOWARD THE DONOR AS WELL AS ALLOWED RED CELLS TO REACH THE BOTTLE. PATIENT INFORMATION AND OUTCOME ARE UNKNOWN AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22337857 ↗
• MalfunctionMay 27, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THE CUSTOMER REPORTED THAT THE RIKA DEVICE ALARMED 1012 VOLUME DISCREPANCY AND A LARGE AMOUNT OF AIR BUBBLES ABOUT 12 INCHES WAS ABOUT TO BE INFUSED INTO THE DONOR. PATIENT INFORMATION AND OUTCOME ARE UNKNOWN. THE COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22091428 ↗
• MalfunctionMay 22, 2025Electrical Power Problem; Electrical Shorting; Insufficient Device Problem Information; Electrical Power Problem; Electrical Shorting; Insufficient Device Problem Information

  THE CUSTOMER REPORTED THAT DURING RINSEBACK A RIKA DEVICE ALARMED FOR A NON-RECOVERABLE ALARM, SOFTWARE ERROR AND AN INTERNAL VOLTAGE SWITCH ERROR. THE DEVICE THEN STARTED TO SMELL OF BURNT PLASTIC AND WIRE AND BEGAN TO SMOKE FROM THE BACK. A SERVICE TECHNICIAN CHECKED OUT THE MACHINE AT THE CUSTOMER SITE ON (B)(6) 2025. AFTER TURNING DEVICE ON THE TECHNICIAN NOTED THE DEVICE INSTANTLY STARTED TO SPARK AND VISUALIZED FIRE AND SMOKE NEXT TO THE INTERFACE CCA BOARD. NO ADDITIONAL EVALUATION WAS PERFORMED AT THAT TIME. PATIENT INFORMATION IS NOT AVAILABLE AT THIS TIME. NO INJURY OR MEDICAL INTERVENTION OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22073702 ↗
• MalfunctionMay 12, 2025No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information

  THE CUSTOMER REPORTED DONOR HAD POST DONATIONS DAE-HEMOGLOBIN IN THEIR URINE. PER THE CUSTOMER, THE UNIT HAS ALREADY BEEN PROCEEDED AND SHIPPED. NO CONCERNS WERE REPORTED BY THE LABORATORY. PER CUSTOMER "DONOR DID NOT REPORT SEEKING FURTHER TREATMENT, NO FURTHER CONCERNS REPORTED BY DONOR". FULL DONOR ID: (B)(6).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22003557 ↗
• MalfunctionNov 21, 2024No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information

  THE CUSTOMER REPORTED A POSSIBLE OVERHARVEST DURING A PROCEDURE ON A RIKA DEVICE. PER THE CUSTOMER THERE WERE NO SIGNS OF A SETUP ERROR. PATIENT INFORMATION AND OUTCOME ARE UNKNOWN AT THIS TIME.

  Patient problems: Hypovolemia; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20746919 ↗
• MalfunctionOct 14, 2024No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information

  THE CUSTOMER REPORTED AN OVERHARVEST ON A RIKA DEVICE. THE DONOR DONATED 800ML+, BUT WAS SUPPOSED TO DONATE 750ML. DONOR INFORMATION AND OUTCOME ARE UNKNOWN AT THIS TIME. THE COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20441260 ↗
• MalfunctionAug 28, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  CUSTOMER REPORTED THAT DURING A PROCEDURE ON A RIKA DEVICE, THE DEVICE ALARMED "RETURN PUMP TRACK NOT IN POSITION" MULTIPLE TIMES AND POTENTIALLY CAUSED HEMOLYSIS IN THE PLASMA BOTTLE. DONOR INFORMATION AND OUTCOME ARE UNKNOWN AT THIS TIME. THE COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

  Patient problems: Hemolysis

  MAUDE report 20091984 ↗
• MalfunctionApr 9, 2024No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information

  THE CUSTOMER REPORTED THAT AT THE END OF A DONOR'S DONATION ON A RIKA DEVICE, THE DEVICE STATED THAT THE DONOR DONATED 825 ML. THE OPERATOR REPORTED THAT THE COLOR IN THE TUBE WAS LIGHT PINK WHEN TAKING DOWN THE SET-UP, AND THE CENTRIFUGED WAS FULL AND NOT EMPTY. PATIENT INFORMATION AND OUTCOME ARE UNKNOWN AT THIS TIME.

  Patient problems: Hypovolemia; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19071188 ↗
• MalfunctionApr 8, 2024No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information

  THE CUSTOMER REPORTED THAT ONLY PARTIAL SALINE WAS GIVEN TO THE DONOR. PATIENT INFORMATION AND OUTCOME ARE UNKNOWN AT THIS TIME.

  Patient problems: Hypovolemia; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19060941 ↗
• MalfunctionApr 8, 2024No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information

  THE CUSTOMER REPORTED THAT DURING A PROCEDURE ON A RIKA DEVICE ONLY PARTIAL SALINE WAS ADMINISTERED TO THE DONOR. PATIENT INFORMATION AND OUTCOME ARE UNKNOWN AT THIS TIME.

  Patient problems: Hypovolemia; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19060452 ↗
• MalfunctionApr 5, 2024No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information

  CUSTOMER REPORTED A POTENTIAL OVER COLLECTION ON A RIKA DEVICE. PATIENT INFORMATION AND OUTCOME ARE UNKNOWN AT THIS TIME.

  Patient problems: Hypovolemia; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19053771 ↗
• MalfunctionApr 5, 2024No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information

  THE CUSTOMER REPORTED THAT DURING A PROCEDURE ON A RIKA DEVICE, THE DEVICE INDICATED THAT THE DONOR RECEIVED 771 ML OF SALINE. NO KINKS WERE NOTED, AND THE SALINE BAG WAS EMPTY AT THE END OF THE PROCEDURE, AND THE DEVICE DID NOT ALARM. NO MEDICAL INTERVENTION WAS REPORTED. PATIENT INFORMATION AND OUTCOME ARE UNKNOWN AT THIS TIME.

  Patient problems: Hypervolemia; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19051533 ↗
• MalfunctionApr 4, 2024No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information

  THE CUSTOMER REPORTED THAT AT THE END OF A COLLECTION ON THE RUN SUMMARY IT SHOWED ESTIMATED SALINE VOLUME AS 771ML AND THE TARGET VOLUME WAS 500ML. PATIENT INFORMATION AND OUTCOME ARE UNKNOWN AT THIS TIME.

  Patient problems: Hypervolemia; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19044482 ↗
• MalfunctionApr 4, 2024No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information

  THE CUSTOMER REPORTED THAT DURING A PROCEDURE ON A RIKA DEVICE, SALINE WAS NOT INFUSED COMPLETELY. NO MEDICAL INTERVENTION WAS REPORTED. PATIENT INFORMATION AND OUTCOME ARE NOT AVAILABLE AT THIS TIME.

  Patient problems: Hypovolemia; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19042027 ↗
• MalfunctionMar 28, 2024No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information

  THE CUSTOMER REPORTED THAT DURING A PROCEDURE ON A RIKA DEVICE, 771 ML OF SALINE WAS DISPENSED TO THE DONOR, WITH AN INTENDED 500 ML TARGET. NO MEDICAL INTERVENTION WAS REPORTED. PATIENT INFORMATION AND OUTCOME ARE UNKNOWN AT THIS TIME.

  Patient problems: Hypervolemia; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18995184 ↗
• MalfunctionMar 28, 2024No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information

  THE CUSTOMER REPORTED THAT DURING A PLASMA DONATION ON A RIKA DEVICE, THE DONOR DID NOT RECEIVE ENOUGH SALINE AT THE END OF THE PROCEDURE. THE OPERATOR DID NOT REALIZE THE DONOR DID NOT RECEIVE THE FULL SALINE AMOUNT, UNTIL THE DONOR HAD ALREADY LEFT THE FACILITY AND THE DEVICE SETUP WAS TAKEN DOWN. NO MEDICAL INTERVENTION WAS REPORTED. FULL DONATION ID: (B)(6). PATIENT INFORMATION AND OUTCOME ARE NOT AVAILABLE AT THIS TIME.

  Patient problems: Hypovolemia; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18994954 ↗