Rika Plasma Separation Set 21200Recalls & reported problems

Summary

The FDA's MAUDE database contains 77 adverse event reports that list this exact device (DI 05020583212008), received between Oct 14, 2022 and Aug 18, 2026 — classified as 10 deaths, 6 injuries, 61 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (76 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 77 reports, in the reporter's own words as published by the FDA.

• DeathAug 18, 2026Insufficient Device Problem Information

  The customer reported that following a plasmapheresis procedure on (b)(6) 2026 using a RIKA device, the donor was found deceased on (b)(6) 2026. The Collection set is not available for return because it was discarded by the customer. This report is being filed due to a reported patient death. At this time, the available information does not indicate a detectable malfunction of the Terumo BCT device, and no device malfunction has been alleged.

  Patient problems: Insufficient Information

  MAUDE report 50303450 ↗
• MalfunctionAug 6, 2026Use of Device Problem; Insufficient Device Problem Information; Device Handling Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50167942 ↗
• MalfunctionJul 2, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THE CUSTOMER REPORTED A HEMOLYZED UNIT AND NO ALARM OCCURRED FROM A PLASMA DONATION. THE HEMOLYSIS WAS IDENTIFIED AFTER PATIENT DISCONNECT AND WAS ONLY OBSERVED IN THE BOTTLE. PER THE CUSTOMER THE ANTI-COAGULANT AND SALINE SOLUTIONS WERE ATTACHED CORRECTLY. THE CUSTOMER DID NOT REPORT ANY IMPACT TO THE PATIENT. FULL PATIENT IDENTIFIER: (B)(6). THE COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

  Patient problems: Hemolysis

  MAUDE report 25695377 ↗
• DeathJun 25, 2026No Apparent Adverse Event; Insufficient Device Problem Information

  The customer reported that they were notified of a donor death by the donor's ex-wife. Per the customer the event occurred off-site. The donor was removed from the device prior to the end of the plasmapheresis run. There was no medical intervention performed.  Full Patient Identifier - (b)(6) The Collection set is not available for return because it was discarded by the customer. 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 25621316 ↗
• MalfunctionMay 19, 2026No Apparent Adverse Event; Insufficient Device Problem Information

  CUSTOMER REPORTED AIR BUBBLES IN THE DONOR LINE. PATIENT 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: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 25218441 ↗
• MalfunctionMay 4, 2026Insufficient Device Problem Information

  THE CUSTOMER REPORTED THAT THE DONOR HAD GONE THROUGH 4 CYCLES WHEN IT WAS OBSERVED THAT BLOOD WAS LEAKING FROM THE LINE AND IT WAS NOTED THAT THERE WERE AIR BUBBLES PRESENT IN THE LINE. PATIENT IDENTIFIER UNKNOWN AT THIS TIME PER CUSTOMER "DONOR STATES OF FEELING GOOD, NO ADVERSE EFFECTS." 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 25071520 ↗
• MalfunctionApr 20, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THE CUSTOMER REPORTED AIR TO DONOR ON A RIKA DEVICE WITH NO ALARM. PATIENT 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: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24926838 ↗
• MalfunctionFeb 10, 2026No Apparent Adverse Event; Insufficient Device Problem Information

  THE CUSTOMER REPORTED AIR BUBBLE IN THE DONOR LINE AND THEY RECEIVED AN ALARM FOR "LEAK DETECTED IN CENTRIFUGE CHAMBER". IT IS UNKNOWN AT THIS TIME IF AIR WAS RETURNED TO THE DONOR. PATIENT INFORMATION AND OUTCOME ARE NOT AVAILABLE AT THIS TIME. THE DISPOSABLES SET IS NOT AVAILABLE FOR RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24306595 ↗
• MalfunctionJan 22, 2026No Apparent Adverse Event; Insufficient Device Problem Information

  THE CUSTOMER REPORTED AIR BUBBLES IN THE DISPOSABLE TUBING SET ON A PLASMA COLLECTION. THE COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER. PROCEDURAL DETAILS, PATIENT INFORMATION, AND PATIENT OUTCOME ARE UNKNOWN AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24149325 ↗
• InjuryJan 15, 2026Manufacturing, Packaging or Shipping Problem; Insufficient Device Problem Information

  THE CUSTOMER REPORTED THAT A DONOR WAS ON DONOR FLOOR WAITING FOR THE VENIPUNCTURE PROCESS IN THE BED. THE DONOR MENTIONED WHILE SHE WAS WAITING, SHE FELT LIQUID IN HER FACE, BUT DIDN'T PAY ATTENTION UNTIL THE LIQUID WAS CONSISTENTLY SPLASHING ON HER FACE AND HANDS AND CLOSE TO HER EYES AND MOUTH. SHE CALLED THE PHLEBOTOMIST TO INFORM THE EVENT. DURING THE INVESTIGATION IT WAS FOUND THAT THE SEPARATION SET ON THE ADJACENT DONOR HAD A PINHOLE THAT PRODUCED A PLASMA SPLASH. THE DONOR WAS INSTRUCTED BY THE SUPERVISOR TO WASH THEIR FACE AND HANDS. IT WAS REPORTED THAT THE DONOR WENT TO THE EMERGENCY ROOM TO BE EVALUATED AND IS UNDER MEDICATION. TERUMO BCT IS AWAITING RETURN OF THE DISPOSABLE SET FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24081962 ↗
• InjuryDec 16, 2025No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information

  THE CUSTOMER REPORTED THAT DURING A RIKA PLASMA COLLECTION, THE DONOR HAD A LESS THAN 200ML LOSS OF RED BLOOD CELLS (RBC). PER THE CUSTOMER UNKNOWN MEDICAL INTERVENTION WAS PROVIDED. DONOR ID AND OUTCOME ARE UNKNOWN AT THIS TIME. THE COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

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

  MAUDE report 23818719 ↗
• MalfunctionDec 11, 2025No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information

  THE CUSTOMER REPORTED POTENTIAL HEMOLYSIS. DONOR INFORMATION AND OUTCOME ARE UNKNOWN AT THIS TIME. TERUMO BCT IS AWAITING RETURN OF THE COLLECTION SET FOR EVALUATION.

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

  MAUDE report 23778791 ↗
• MalfunctionNov 25, 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 POTENTIAL HEMOLYSIS. DONOR INFORMATION AND OUTCOME ARE UNKNOWN AT THIS TIME. THERE WAS NO SERIOUS INJURY OR MEDICAL INTERVENTION THAT OCCURRED FOR THIS EVENT. THE COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

  Patient problems: Hemolysis

  MAUDE report 23647451 ↗
• DeathNov 24, 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 A PATIENT DEATH OCCURRED ON (B)(6) 2025 AFTER DONATING ON (B)(6) 2025. THE CENTER WAS INFORMED ON (B)(6) 2025. THE CUSTOMER DOES NOT SUSPECT THE DEVICE CONTRIBUTED TO THE PATIENT DEATH, BUT CAUSE OF DEATH IS UNKNOWN. OBITUARY REPORTED "NATURAL CAUSES" AS SUSPECTED CAUSE OF DEATH. THE CUSTOMER DOES NOT HAVE THE EXACT TIME OF DEATH; HOWEVER, THEY STATED PROCEDURE STARTED AT JUST AFTER 2:50 PM LOCAL TIME. DONOR DEATH OCCURRED APPROXIMATELY 3 DAYS AFTER PLASMA DONATION. PER THE CUSTOMER, THERE WERE NO MEDICATIONS GIVEN OR TREATMENTS PERFORMED PRIOR TO, DURING OR FOLLOWING THE PROCEDURE. THE COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER. 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23631877 ↗
• MalfunctionNov 13, 2025No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information

  THE CUSTOMER REPORTED THAT THEY OBSERVED AIR IN THE DONOR LINE. 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: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23543317 ↗
• InjuryOct 30, 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 DURING A PLASMA COLLECTION PROCEDURE THE DONOR BEGAN FEELING ILL WHEN THE NEEDLE WAS REMOVED AFTER AN UNSUCCESSFUL RE-STICK. THE RUN WAS PUT IN RINSEBACK DUE TO THE UNSUCCESSFUL RESTICK AND FLUID NOT FLOWING. THE RINSEBACK WAS ENDED DUE TO THE DONOR DEVELOPING A HEMATOMA. THE PATIENT BECAME CONFUSED, DISORIENTED AND LOST CONSCIOUS. THE DONATION WAS STOPPED AT THAT TIME AND EMS WAS CALLED AND THE PATIENT WAS TAKEN TO THE HOSPITAL. PER CUSTOMER "THE DONOR WAS DISCHARGED AT SOME POINT BUT DIED ON (B)(6) 2025, DAYS AFTER BEING RELEASED FROM THE HOSPITAL". THE CUSTOMER DID NOT SUSPECT THE DEVICE CAUSED OR CONTRIBUTED TO THE DEATH BUT CAUSE OF DEATH WAS LISTED AS UNKNOWN. PATIENT STATE AT THE DONATION WAS NORMAL AND PASSED THE VITAL SCREENING. DONATION ID: (B)(6) THE COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER. 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: Confusion/ Disorientation; Loss of consciousness

  MAUDE report 23426905 ↗
• DeathOct 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 A DONOR DEATH THAT OCCURRED ON (B)(6) 2025, THE PROCEDURE WAS PERFORMED THE DAY PRIOR ON (B)(6) 2025. THE WIFE OF THE DONOR REACHED OUT TO THE CUSTOMER SITE TO INFORM OF THE DEATH BUT WOULD NOT PROVIDE FURTHER DETAILS. FULL PATIENT IDENTIFIER: (B)(6), DONOR#: (B)(6) THE COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER. 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 23392696 ↗
• MalfunctionSep 8, 2025No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information

  THE CUSTOMER REPORTED AIR BUBBLES IN THE DONOR LINE. PATIENT 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 22994797 ↗
• MalfunctionSep 5, 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 BUBBLES WERE IDENTIFIED IN THE DONOR LINE NEAR SOFT CASSETTE AND THE DONATION WAS IMMEDIATELY ENDED. PATIENT 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 22979569 ↗
• MalfunctionSep 2, 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 DURING A COLLECTION, THEY RECEIVED ALARM "RETURN PUMP IS NOT TURNING AT TARGET SPEED" AT WHICH POINT THE PROCESS WAS DISCONTINUED DUE TO UNRESOLVABLE ALARMS. DURING THE RETURN OF THE CELLS AND SALINE, IT WAS NOTICED THAT THE RETURN WAS SLOW EVEN THOUGH THE MACHINE WAS SET AT HIGH. THE SALINE WAS GIVEN AND NO KINKS WERE NOTICED DURING DC, BUT AIR BUBBLES WERE PRESENT IN THE DONOR LINE. PATIENT IDENTIFIER IS UNKNOWN AT THIS TIME. PER CUSTOMER "DONOR STABLE UPON RELEASE". THE DONOR IS CURRENTLY QUALIFIED WITH NO ACTIVE DEFERRALS, THEY HAVE NOT DONATED SINCE THE EVENT, AND NO ADDITIONAL INFORMATION KNOWN. THE CUSTOMER INDICATED ON FOLLOW-UP THAT AIR WAS OBSERVED IN THE TUBING ON THE DONOR SIDE OF THE SOFT CASSETTE. ALL THE LUER CONNECTIONS WERE TIGHT. IT WAS NOT KNOWN IF THERE WAS CLOTTING IN THE CHANNEL OR IN THE RETURN CHAMBER BECAUSE NOTHING WAS NOTED BY THE OPERATOR DURING THE CASE CREATION. THERE WAS NO MEDICAL INTERVENTION. 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 22938692 ↗
• InjuryAug 29, 2025No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information

  CUSTOMER REPORTED A POST DONATION VASOVAGAL REACTION. PATIENT OUTCOME IS UNKNOWN AT THIS TIME. TERUMO BCT IS AWAITING RETURN OF THE DISPOSABLE SET FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Syncope/Fainting

  MAUDE report 22922631 ↗
• MalfunctionAug 14, 2025No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information

  THE CUSTOMER REPORTED AIR BUBBLES IN THE LINE DURING A PROCEDURE ON A RIKA DEVICE. THE DEVICE DID NOT ALARM. PATIENT 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 22805490 ↗
• MalfunctionAug 12, 2025No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information

  THE CUSTOMER REPORTED THAT THEY OBSERVED AIR BUBBLES IN THE LINE. PATIENT 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: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22782828 ↗
• MalfunctionAug 11, 2025No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information

  CUSTOMER REPORTED POTENTIAL HEMOLYSIS IN THE 3RD DRAW CYCLE DURING A PLASMA COLLECTION PROCEDURE. AFTER 2 MORE DRAW CYCLES AND 3 RETURN CYCLES THE DEVICE ALARMED "4402: POTENTIAL HEMOLYSIS DETECTED " ON THE 6TH DRAW CYCLE. THE SOLUTIONS WERE CORRECTLY ATTACHED AND NO CLOTS WERE OBSERVED IN THE CHANNEL OR CHANNEL LINES. PER THE CUSTOMER "THE SET WAS LOOKED AT, NO HEMOLYSIS OBSERVED" PATIENT OUTCOME UNKNOWN AT THIS TIME. THE COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

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

  MAUDE report 22770825 ↗
• MalfunctionAug 7, 2025No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information

  THE CUSTOMER REPORTED ALARMS FOR "FLUID IS NOT DETECTED IN DONOR LINE DURING A RETURN CYCLE" AND "ACCESS PRESSURE IS TOO HIGH" AND NOTICED AIR BUBBLES THROUGHOUT THE DONOR LINE DURING SALINE RETURN. PATIENT 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 22737866 ↗