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 02/12/2024

Event Type  malfunction  

Manufacturer Narrative

Investigation: a terumo bct service technician checked out the machine at a customer site.The technician inspected hardware tab to confirm valves functions working properly.An air-filled tube and a fluid-filled tube was inserted onto donor line sensor to observe sensor status.Donor line sensor working properly.Removed return pump assembly and dual-valve assembly as per r&r.Inspected for any loose connections and no electrical connections and valves were loose.Removed return pump rotor as per r&r.Inspected rotor for debris and obstructions and found none.Cleaned rotor and where the rotor sits as per r&r.Performed return pump cca and dual-valve pump cca auto tests with passing results.Performed weigh station calibration with passing results.Performed cps calibration with passing results.Performed fluid tests with passing results.Alarm wasn't able to be duplicated.Device working as intended.Investigation is in process, a follow-up report will be provided.

Event Description

The customer reported that during a collection procedure on rika only 18 mls of saline were administered to the donor after rinseback.The customer reported receiving alarm 4404: saline not detected.Full donor id: 11421470179 patient age, gender, weight and outcome are unknown at this time.The collection set is not available for return because it was discarded by the customer.

Manufacturer Narrative

Investigation: a terumo bct service technician checked out the machine at a customer site.The technician inspected hardware tab to confirm valves functions working properly.An air-filled tube and a fluid-filled tube was inserted onto donor line sensor to observe sensor status.Donor line sensor working properly.Removed return pump assembly and dual-valve assembly as per r&r.Inspected for any loose connections and no electrical connections and valves were loose.Removed return pump rotor as per r&r.Inspected rotor for debris and obstructions and found none.Cleaned rotor and where the rotor sits as per r&r.Performed return pump cca and dual-valve pump cca auto tests with passing results.Performed weigh station calibration with passing results.Performed cps calibration with passing results.Performed fluid tests with passing results.Alarm wasn't able to be duplicated.Device working as intended.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 Description

The customer reported that during a collection procedure on rika only 18 mls of saline were administered to the donor after rinseback.The customer reported receiving alarm 4404: saline not detected.Full donor id: (b)(6).Patient age, gender, weight and outcome are unknown at this time.The collection set is not available for return because it was discarded by the customer.

• 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: 18896527
• MDR Text Key: 337580148
• Report Number: 1722028-2024-00080
• 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: 03/13/2024

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
• Device Operator: Health Professional
• Device Model Number: 42000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/12/2024
• Initial Date FDA Received: 03/13/2024
• Supplement Dates Manufacturer Received: 04/17/2024
• Supplement Dates FDA Received: 04/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/24/2023
• 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