MAUDE Adverse Event Report: TERUMO BCT RIKA PLASMA DONATION SYSTEM

Model Number 42000

Device Problems No Apparent Adverse Event (3189); Insufficient Information (3190)

Patient Problems Hypervolemia (2664); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/07/2024

Event Type  malfunction  

Manufacturer Narrative

Investigation: a terumo bct service technician checked out the device at the customer site and tested the return pump and dual valve in the hardware tab with passing results.The technician also performed a return pump cca and dual valve cca auto-test with passing results.Per terumo bct evaluation of the device, it was not the device that caused the malfunction.Evaluation included performing a fluid test with passing results.The device was operating normally.Per the run data file (rdf), this run was performed using nomogram a and 750 ml of plasma was in the plasma bottle at the end of the run.The donor weight was 153.99 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 3739 ml.3739 ml - 750 ml = 2389 ml (2389 ml-0 ml-3739 ml)/3739 ml*100 = -23.89% fluid balance investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that during a procedure on a rika device, saline was not administered to the donor after the plasma donation.There were no alarms when the incident occurred, the setup was verified, and no kinks were discovered.No medical intervention was reported.Full donation id: #(b)(6) patient age, gender and outcome are not available at this time.

Event Description

The customer reported that during a procedure on a rika device, saline was not administered to the donor after the plasma donation.There were no alarms when the incident occurred, the setup was verified, and no kinks were discovered.No medical intervention was reported.Full donation id: #(b)(6).

Manufacturer Narrative

Investigation: a terumo bct service technician checked out the device at the customer site and tested the return pump and dual valve in the hardware tab with passing results.The technician also performed a return pump cca and dual valve cca auto-test with passing results.Per terumo bct evaluation of the device, it was not the device that caused the malfunction.Evaluation included performing a fluid test with passing results.The device was operating normally.Per the run data file (rdf), this run was performed using nomogram a and 750 ml of plasma was in the plasma bottle at the end of the run.The donor weight was 153.99 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 3739 ml.3739 ml - 750 ml = 2389 ml (2389 ml-0 ml-3739 ml)/3739 ml*100 = -23.89% fluid balance after reaching out to the customer regarding this collection, they provided the following donor information: no medical intervention required on a 43 yo female with an hct of 32, 5' 3" and 154 pounds.Per the dlog, this run was performed using nomogram a and 750 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 3953 ml.3953 ml - 750 ml = 3203 ml (3203 ml-0 ml-3953 ml)/3953 ml*100 = -18.97% 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
• Type of Device: 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: 18993679
• MDR Text Key: 339037462
• Report Number: 1722028-2024-00109
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583420007
• UDI-Public: 05020583420007
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK210635
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 42000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/03/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/14/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 43 YR
• Patient Sex: Female