MAUDE Adverse Event Report: TERUMO BCT RIKA PLASMA DONATION SYSTEM

Model Number	42000
Medical Device Problem Codes	No Apparent Adverse Event (3189); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Hypervolemia (2664); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation: a terumo bct technician performed a dual-valve replacement with weight station calibration followed by performing a dual-valve auto test and fluid test with passing results.A collection procedure mocked with estimated saline volume of 500 ml at the collection summary was successfully completed.Investigation is in process, a follow-up report will be provided.
Event or Problem Description
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.
Additional Manufacturer Narrative
Invesitgation: a terumo bct technician performed a dual-valve replacement with weight station calibration followed by performing a dual-valve auto test and fluid test with passing results.A collection procedure mocked with estimated saline volume of 500 ml at the collection summary was successfully completed.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.Per terumobct internal risk associated with hypovolemia for the rika plasma donation system, this complaint does not meet the requirements for reportability.No further reporting will be provided as this does not represent a reportable event.
Event or Problem Description
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.

• 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: 19044482
• Report Number: 1722028-2024-00121
• Device Sequence Number: 8472209
• 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): 04/04/2024

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: 03/12/2024
• Supplement Date Received by Manufacturer: 04/17/2024
• Initial Report FDA Received Date: 04/04/2024
• Supplement Report FDA Received Date: 04/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/11/2023
• 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