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 Hypovolemia (2243); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/05/2024

Event Type  malfunction  

Event Description

The customer reported that during a procedure on a rika device, saline was not infused to the donor after device alarm ¿saline is not detected¿, and the device was removed from service.There was no red blood cell (rbc) loss to the donor.No kinks were reported in the set.No medical intervention was reported, and the donor was stable upon release.Donor information is unknown at this time.

Manufacturer Narrative

Investigation: a terumo bct service technician checked out the device at the customer site and cleaned the device, inspected the electrical connections to and from the line sensor, and used the hardware tab to test the sensor status and determined the signal was operating correctly.The technician also cleaned the rotor pump and used the hardware tab with a tube in the return pump raceway, with the motor on, and determined the raceway moves correctly with occlusion.The technician performed a return pump cca auto test and a fluid test with passing results.Investigation is in process.A follow up report will be provided.

Manufacturer Narrative

This report is being filed to provide corrected information in g.4.Investigation: a terumo bct service technician checked out the device at the customer site and cleaned the device, inspected the electrical connections to and from the line sensor, and used the hardware tab to test the sensor status and determined the signal was operating correctly.The technician also cleaned the rotor pump and used the hardware tab with a tube in the return pump raceway, with the motor on, and determined the raceway moves correctly with occlusion.The technician performed a 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.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.

Event Description

The customer reported that during a procedure on a rika device, saline was not infused to the donor after device alarm ¿saline is not detected¿, and the device was removed from service.There was no red blood cell (rbc) loss to the donor.No kinks were reported in the set.No medical intervention was reported, and the donor was stable upon release.Donor information is unknown at this time.

Event Description

The customer reported that during a procedure on a rika device, saline was not infused to the donor after device alarm ¿saline is not detected¿, and the device was removed from service.There was no red blood cell (rbc) loss to the donor.No kinks were reported in the set.No medical intervention was reported, and the donor was stable upon release.Donor information is unknown at this time.

Manufacturer Narrative

Investigation: a terumo bct service technician checked out the device at the customer site and cleaned the device, inspected the electrical connections to and from the line sensor, and used the hardware tab to test the sensor status and determined the signal was operating correctly.The technician also cleaned the rotor pump and used the hardware tab with a tube in the return pump raceway, with the motor on, and determined the raceway moves correctly with occlusion.The technician performed a 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.It was confirmed that the final fluid balance was within the (b)(4) 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: 18992543
• MDR Text Key: 339035328
• Report Number: 1722028-2024-00106
• 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,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: 04/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2023
• 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