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	Hypovolemia (2243); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation: a terumo bct service technician checked out the device at the customer site and performed a fluid a test and received passing results.The technician also performed a mock procedure and the device initiated rinseback and returned sodium chloride (nacl) as expected.Device is operating as intended.Per the run data file (rdf) for this procedure, 880 ml of fluid (plasma + ac) was in the plasma bottle at the end of the run, which indicates this donor had a minimum weight of 175 lbs; and 138 ml of saline was returned to the donor.A historical review of customer data indicated the minimum donor height was 4' 3", so a worst-case minimum height is assumed to be 4' for this record.Using nadler's equation for tbv, a worst-case donor for this donation volume would have a starting tbv of approximately 3454 ml.3454 ml - 880 ml = 2574 ml (2574 ml+138 ml-3454 ml) 3454 ml*100 = -21.48% fluid balance investigation is in process.A follow-up report will be provided.
Event or Problem Description
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.
Event or Problem Description
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.
Additional Manufacturer Narrative
This report is being filed to provide investigation: a terumo bct service technician checked out the device at the customer site and performed a fluid a test and received passing results.The technician also performed a mock procedure and the device initiated rinseback and returned sodium chloride (nacl) as expected.Device is operating as intended.Per the run data file (rdf) for this procedure, 880 ml of fluid (plasma + ac) was in the plasma bottle at the end of the run, which indicates this donor had a minimum weight of 175 lbs; and 138 ml of saline was returned to the donor.A historical review of customer data indicated the minimum donor height was 4' 3", so a worst-case minimum height is assumed to be 4' for this record.Using nadler's equation for tbv, a worst-case donor for this donation volume would have a starting tbv of approximately 3454 ml.3454 ml - 880 ml = 2574 ml (2574 ml+138 ml-3454 ml)/3454 ml*100 = -21.48% fluid balance after reaching out to the customer regarding this collection, they provided the following donor information: no medical intervention required on a 53 yo female with an hct of 46, 5' 6" and 216 pounds.Per the dlog, 880 ml of fluid (plasma + ac) was in the plasma bottle at the end of the run and 138 ml of saline was returned to the donor.Using nadler's equation for tbv, a worst-case donor for this donation volume would have a starting tbv of approximately 5102 ml.5102 ml - 880 ml = 4222 ml (4222 ml+138 ml-5102 ml)/5102 ml*100 = -14.54% fluid balance 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.It was confirmed that the final fluid balance was within the +/- 20% threshold.No further reporting will be provided as this does not represent a reportable event.

• 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: 18994954
• Report Number: 1722028-2024-00108
• Device Sequence Number: 11512509
• Product Code: GKT
• UDI-Device Identifier: 05020583420007
• UDI-Public: 05020583420007
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: BK231035
• 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): 03/28/2024

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: 03/05/2024
• Supplement Date Received by Manufacturer: 04/03/2024
• Initial Report FDA Received Date: 03/28/2024
• Supplement Report FDA Received Date: 04/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/29/2022
• 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