RIKA
Report
- Report Number
- 1722028-2025-00089
- Event Type
- Malfunction
- Date Received
- April 14, 2025
- Date of Event
- March 21, 2025
- Report Date
- April 14, 2025
- Manufacturer
- TERUMO BCT
- Product Code
- GKT
- UDI-DI
- 05020583212008
- PMA / PMN Number
- BK241097
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THIS REPORT IS BEING FILED TO PROVIDE ADDITIONAL INFORMATION IN A.2, A.3, A.4, B.5, E.1 H.6, H.11 AND CORRECTIONS IN D.9 AND E.1 INVESTIGATION: A TERUMO BCT SERVICE TECHNICIAN CHECKED OUT THE MACHINE AT A CUSTOMER SITE AND PERFORMED A FLUID TEST PERFORMED THAT PASSED, DEVICE IS WORKING AS INTENDED. INVESTIGATION IS IN PROCESS, A FOLLOW-UP REPORT WILL BE PROVIDED.
THIS REPORT IS BEING FILED TO PROVIDE ADDITIONAL INFORMATION IN A.1, H.6 AND H.11 AND CORRECTIONS IN D.1, D.2A, D.4, AND H.4. INVESTIGATION: A TERUMO BCT SERVICE TECHNICIAN CHECKED OUT THE MACHINE AT A CUSTOMER SITE AND PERFORMED A FLUID TEST PERFORMED THAT PASSED, DEVICE IS WORKING AS INTENDED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THIS UNIT SHOWED NO IRREGULARITIES DURING MANUFACTURING THAT WERE RELEVANT TO THIS ISSUE. INVESTIGATION IS IN PROCESS, A FOLLOW-UP REPORT WILL BE PROVIDED.
THIS REPORT IS BEING FILED TO PROVIDE ADDITIONAL INFORMATION IN H.6 AND H.11. INVESTIGATION: A TERUMO BCT SERVICE TECHNICIAN CHECKED OUT THE MACHINE AT A CUSTOMER SITE AND PERFORMED A FLUID TEST PERFORMED THAT PASSED, DEVICE IS WORKING AS INTENDED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THIS UNIT SHOWED NO IRREGULARITIES DURING MANUFACTURING THAT WERE RELEVANT TO THIS ISSUE. A DISPOSABLE COMPLAINT HISTORY SEARCH WAS PERFORMED FOR THIS LOT AND THERE WERE NO OTHER REPORTS FOR SIMILAR ISSUES ON THIS LOT. THE RUN DATA FILE (RDF) WAS ANALYZED FOR THIS EVENT. REVIEW INDICATED POSSIBLE SOME LOW LEVEL, HEMOLYSIS COULD HAVE BEEN OCCURRING THROUGHOUT THE RUN BASED ON THE REDTRANS HOLDING STEADY THROUGHOUT THE PROCEDURE AND THE BLUETRANS DROPPING EACH DRAW. ADDITIONALLY, THE HEMOLYSIS ALARM DID NOT OCCUR, BECAUSE IT DOESN¿T MEET OUR ALARM AND HEMOLYSIS SAFETY THRESHOLDS. INVESTIGATION IS IN PROCESS, A FOLLOW-UP REPORT WILL BE PROVIDED.
THIS REPORT IS BEING FILED TO PROVIDE ADDITIONAL INFORMATION IN D.4, B.5, B.7, H.6 AND H.11 AND CORRECTION IN A.4, D.1, H.5 AND H.8. INVESTIGATION: A TERUMO BCT SERVICE TECHNICIAN CHECKED OUT THE MACHINE AT A CUSTOMER SITE AND PERFORMED A FLUID TEST PERFORMED THAT PASSED, DEVICE IS WORKING AS INTENDED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THIS UNIT SHOWED NO IRREGULARITIES DURING MANUFACTURING THAT WERE RELEVANT TO THIS ISSUE. A DISPOSABLE COMPLAINT HISTORY SEARCH WAS PERFORMED FOR THIS LOT AND THERE WERE NO OTHER REPORTS FOR SIMILAR ISSUES ON THIS LOT. THE RUN DATA FILE (RDF) WAS ANALYZED FOR THIS EVENT. REVIEW INDICATED POSSIBLE SOME LOW LEVEL, HEMOLYSIS COULD HAVE BEEN OCCURRING THROUGHOUT THE RUN BASED ON THE REDTRANS HOLDING STEADY THROUGHOUT THE PROCEDURE AND THE BLUETRANS DROPPING EACH DRAW. ADDITIONALLY, THE HEMOLYSIS ALARM DID NOT OCCUR, BECAUSE IT DOESN¿T MEET OUR ALARM AND HEMOLYSIS SAFETY THRESHOLDS. ROOT CAUSE: A ROOT CAUSE ASSESSMENT WAS PERFORMED FOR THIS COMPLAINT. BASED ON THE AVAILABLE INFORMATION, A DEFINITIVE ROOT CAUSE FOR HEMOLYSIS COULD NOT BE DETERMINED BUT IT IS LIKELY DUE TO ONE OR A COMBINATION OF THE POSSIBLE CAUSES LISTED BELOW: ¿ DONOR PHYSIOLOGY SUCH AS ICTERIC PLASMA OR LIPEMIC PLASMA. ¿ USER LOADING ERRORS THAT CAUSE OCCLUSIONS ¿ MANUFACTURING ERRORS THAT CAUSE DISPOSABLE OCCLUSIONS CORRECTION: IT WAS DETERMINED THAT THE CUSTOMER WAS NOT AWARE OF THE KNOWLEDGE ARTICLE FOR SUSPECTED HEMOLYSIS FROM TBCT, WHICH INSTRUCTS THEM TO KEEP THE DISPOSABLES SET. THE TECHNICIAN PROVIDED THE KNOWLEDGE ARTICLE TO THE CENTER MANAGER AND HE INDICATED HE WILL PASS THIS ALONG TO THE REST OF THE CENTER AND ENSURE THAT THIS PROCESS IS FOLLOWED MOVING FORWARD.
INVESTIGATION: A TERUMO BCT SERVICE TECHNICIAN CHECKED OUT THE MACHINE AT A CUSTOMER SITE AND PERFORMED A FLUID TEST PERFORMED THAT PASSED, DEVICE IS WORKING AS INTENDED. INVESTIGATION IS IN PROCESS; A FOLLOW-UP REPORT WILL BE PROVIDED.
THIS REPORT IS BEING FILED TO PROVIDE ADDITIONAL INFORMATION IN H.6 AND H.11. INVESTIGATION: A TERUMO BCT SERVICE TECHNICIAN CHECKED OUT THE MACHINE AT A CUSTOMER SITE AND PERFORMED A FLUID TEST PERFORMED THAT PASSED, DEVICE IS WORKING AS INTENDED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THIS UNIT SHOWED NO IRREGULARITIES DURING MANUFACTURING THAT WERE RELEVANT TO THIS ISSUE. INVESTIGATION IS IN PROCESS, A FOLLOW-UP REPORT WILL BE PROVIDED.
CUSTOMER REPORTED SUSPECTED HEMOLYSIS ON A RIKA DEVICE. PATIENT ID IS UNKNOWN AT THIS TIME. PER CUSTOMER "HE WAS FINE" THE COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.
CUSTOMER REPORTED SUSPECTED HEMOLYSIS ON A RIKA DEVICE. PER THE CUSTOMER, "HE WAS FINE" THE COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.
CUSTOMER REPORTED SUSPECTED HEMOLYSIS ON A RIKA DEVICE. PER THE CUSTOMER, "HE WAS FINE" THE COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.
THE CUSTOMER REPORTED SUSPECTED HEMOLYSIS ON A RIKA DEVICE. NO HEMOLYSIS TESTING WAS PERFORMED. PER THE CUSTOMER, THEY GAVE THE DONOR A SODIUM DRINK (ORAL FLUIDS) AND SAT FOR 15 MINUTES. HE WAS REPORTED AS "FINE". FOLLOW-UP WITH THE DONOR YIELDED THAT HE DIDN¿T HAVE ISSUES AND ¿HIS BILATERAL AC WERE CLEAR¿. THE COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.
CUSTOMER REPORTED SUSPECTED HEMOLYSIS ON A RIKA DEVICE. PATIENT INFORMATION AND OUTCOME ARE UNKNOWN AT THIS TIME.
CUSTOMER REPORTED SUSPECTED HEMOLYSIS ON A RIKA DEVICE. PATIENT ID IS UNKNOWN AT THIS TIME. PER CUSTOMER "HE WAS FINE" THE COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 989591 | RIKA | RIKA PLASMA SEPARATION SET | GKT | TERUMO BCT | 42000 | 2412123261 | 05020583212008 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 41 YR | Male | Other |