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	02/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that during a procedure on a rika device, 771 ml of saline was dispensed to the donor, with an intended 500 ml target.No medical intervention was reported.Patient information and outcome are unknown at this time.
Additional Manufacturer Narrative
Investigation: a terumo bct service technician checked out the device at the customer site and performed a return pump auto test and fluid test with passing results.Per the run data file (rdf), this run was performed using nomogram a and 800 ml of plasma was in the plasma bottle at the end of the run; the donor weight was 204 lbs and 771 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.Since 771 ml of saline cannot be returned to the donor from a 500 ml bag, 0ml of saline returned will be assumed for this collection.Using nadler's equation for tbv, a worst-case donor for this donation volume would have a starting tbv of approximately 3890 ml.3890 ml - 800 ml = 3090 ml (3090 ml-0 ml-3890 ml)/3890 ml*100 = -20.57% fluid balance investigation in in process, a follow-up report will be provided.
Event or Problem Description
The customer reported that during a procedure on a rika device, 771 ml of saline was dispensed to the donor, with an intended 500 ml target.No medical intervention was reported.Patient information and outcome are unknown at this time.
Additional Manufacturer Narrative
This report is being filed to provide additional information in h.6 and h.11.Investigation: a terumo bct service technician checked out the device at the customer site and performed a return pump auto test and fluid test with passing results.After reaching out to the customer regarding this collection, they provided the following donor information: no medical intervention required on a 46 yo male with an hct of 46, 5' 7" and 204 pounds.Per the dlog, this run was performed using nomogram a and 800 ml of plasma was in the plasma bottle at the end of the run and 771 ml of saline was returned to the donor.Since 771 ml of saline cannot be returned to the donor from a 500 ml bag, 0ml of saline returned will be assumed for this collection.Using nadler's equation for tbv, a worst-case donor for this donation volume would have a starting tbv of approximately 5391 ml.5391 ml - 800 ml = 4591 ml (4591 ml-0 ml-5391 ml)/5391 ml*100 = -14.84% 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.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.

• 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: 18995184
• Report Number: 1722028-2024-00110
• Device Sequence Number: 2997112
• Product Code: GKT
• UDI-Device Identifier: 05020583420007
• UDI-Public: 05020583420007
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 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: 03/06/2024
• Supplement Date Received by Manufacturer: 04/10/2024
• Initial Report FDA Received Date: 03/28/2024
• Supplement Report FDA Received Date: 04/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/28/2023
• 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