MAUDE Adverse Event Report: TERUMO BCT RIKA PLASMA DONATION SYSTEM

Model Number	42000
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Hemolysis (1886)
Date of Event	08/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation: a terumo bct service technician checked out the device at the customer site.The service technician loaded the tubing into the raceway and determined that the signal status failed to indicate properly and replaced the return pump assembly per instruction.The technician further evaluated the device post repair, as the device required a functional check due to the transducer being out of calibration.The technician performed cps calibrations, return pump cca auto-test, and a fluid-test with passing results.Investigation is in process, a follow-up report will be provided.
Event or Problem Description
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.
Additional Manufacturer Narrative
Investigation: a terumo bct service technician checked out the device at the customer site.The service technician loaded the tubing into the raceway and determined that the signal status failed to indicate properly and replaced the return pump assembly per instruction.The technician further evaluated the device post repair, as the device required a functional check due to the transducer being out of calibration.The technician performed cps calibrations, return pump cca auto-test, and a fluid-test with passing results.Further evaluation of this event has determined that the device did not cause or contribute to a death or serious injury, nor is there a likely potential for death or serious injury associated with this event based on additional investigational information.The run data file shows that this is an rbc spillover and there is no hemolysis.No further reporting will be provided as this does not represent a reportable event.
Event or Problem Description
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.

• Brand Name: RIKA PLASMA DONATION SYSTEM
• Common Device Name: RIKA PLASMA DONATION SYSTEM
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer (Section G): TERUMO BCT; 10810 w. collins ave; lakewood CO 80215
• Manufacturer Contact: scot hilden ; 10810 w. collins ave; lakewood, CO 80215
• MDR Report Key: 20091984
• Report Number: 1722028-2024-00362
• Device Sequence Number: 18095412
• Product Code: GKT
• UDI-Device Identifier: 05020583420007
• UDI-Public: 05020583420007
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: BK210635
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 42000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2024
• Supplement Date Received by Manufacturer: 09/04/2024
• Initial Report FDA Received Date: 08/28/2024
• Supplement Report FDA Received Date: 09/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/27/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown