MAUDE Adverse Event Report: TERUMO BCT RIKA; RIKA PLASMA DONATION SYSTEM

Model Number	42000
Medical Device Problem Codes	Electrical Power Problem (2925); Electrical Shorting (2926); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that during rinseback a rika device alarmed for a non-recoverable alarm, software error and an internal voltage switch error.The device then started to smell of burnt plastic and wire and began to smoke from the back.A service technician checked out the machine at the customer site on (b)(6) 2025.After turning device on the technician noted the device instantly started to spark and visualized fire and smoke next to the interface cca board.No additional evaluation was performed at that time.Patient information is not available at this time.No injury or medical intervention occurred.
Additional Manufacturer Narrative
Investigation: a service technician checked out the machine at the customer site on (b)(6) 2025.After turning device on, the technician noted the device instantly started to spark and visualized fire and smoke next to the interface cca board.No additional evaluation was performed at that time.On 05/08/2025 a service technician determined the low-pressure relief valve experienced a failure that caused damage to the interface circuit card assembly (cca), the multifunction cca and the gpio harness.All 4 parts and a new air module were removed and replaced.On 05/09/2025 a service technician replaced the gpio cable, the interface cca and multifunction cca.On 5/14/2025 a service technician completed an electrical safety, high- and low-pressure calibration, multifunction auto test and fluid test.All tests had passing results.Corrective action: based on preliminary investigation performed, the cause of this event is related to a short circuit of a component within the pressure relief valve used in the manufacturing of the finished device.A short circuit of the component may occur when the voltage applied to the pressure valve assembly exceeds the voltage specified.Because this may be observed in all commercialized units of rika plasma donation system a voluntary field action will be initiated.Investigation is in process.A follow-up report will be provided.
Additional Manufacturer Narrative
This report is being filed to provide additional information in h.6 and h.11.Investigation: a service technician checked out the machine at the customer site on (b)(6) 2025.After turning device on the technician noted the device instantly started to spark and visualized fire and smoke next to the interface cca board.No additional evaluation was performed at that time.On (b)(6) 2025 a service technician determined the low-pressure relief valve experienced a failure that caused damage to the interface circuit card assembly (cca), the multifunction cca and the gpio harness.All 4 parts and a new air module were removed and replaced.On (b)(60 2025 a service technician replaced the gpio cable, the interface cca and multifunction cca.On (b)(6) 2025 a service technician completed an electrical safety, high- and low-pressure calibration, multifunction auto test and fluid test.All tests had passing results.Three photographs were submitted in lieu of the disposables set to aid in the investigation.Analysis of the images confirmed burn mark and fire next to the interface cca board.It was also noted that the side panels were removed.Corrective action: based on preliminary investigation performed, the cause of this event is related to a short circuit of a component within the pressure relief valve used in the manufacturing of the finished device.A short circuit of the component may occur when the voltage applied to the pressure valve assembly exceeds the voltage specified.Because this may be observed in all commercialized units of rika plasma donation system a voluntary field action will be initiated.Investigation is in process.A follow-up report will be provided.
Event or Problem Description
The customer reported that during rinseback a rika device alarmed for a non-recoverable alarm, software error and an internal voltage switch error.The device then started to smell of burnt plastic and wire and began to smoke from the back.A service technician checked out the machine at the customer site on (b)(6) 2025.After turning device on the technician noted the device instantly started to spark and visualized fire and smoke next to the interface cca board.No additional evaluation was performed at that time.Patient information is not available at this time.No injury or medical intervention occurred.
Additional Manufacturer Narrative
This report is being filed to provide additional information in h.11.Investigation: a service technician checked out the machine at the customer site on 04/30/2025.After turning device on the technician noted the device instantly started to spark and visualized fire and smoke next to the interface cca board.No additional evaluation was performed at that time.On 05/08/2025 a service technician determined the low-pressure relief valve experienced a failure that caused damage to the interface circuit card assembly (cca), the multifunction cca and the gpio harness.All 4 parts and a new air module were removed and replaced.On 05/09/2025 a service technician replaced the gpio cable, the interface cca and multifunction cca.On 5/14/2025 a service technician completed an electrical safety, high- and low-pressure calibration, multifunction auto test and fluid test.All tests had passing results.Three photographs were submitted in lieu of the disposables set to aid in the investigation.Analysis of the images confirmed burn mark and fire next to the interface cca board.It was also noted that the side panels were removed.Corrective action: based on preliminary investigation performed, the cause of this event is related to a short circuit of a component within the pressure relief valve used in the manufacturing of the finished device.A short circuit of the component may occur when the voltage applied to the pressure valve assembly exceeds the voltage specified.Because this may be observed in all commercialized units of rika plasma donation system a voluntary field action will be initiated.Corrective action update 07/09/2025: terumo blood and cell technologies initiated a voluntary field correction for rika plasma donation systems (catalog number 42000) following identification of a potential issue involving an electrical component within the high-pressure and/or low-pressure control valve.Preliminary findings indicated the issue was related to a short circuit within the pressure relief valve component, which may occur if the voltage applied exceeds the specified range.While the occurrence is limited, the issue could potentially affect all commercialized rika units.As a precautionary measure, a voluntary field action was initiated.Customers were initially notified on 23 may 2025 via a voluntary medical device field correction letter.Following the start of the field correction, additional implementation details required a follow-up communication to customers.This was shared as part of a service message outlining the continuation of the corrective activities.These activities are now being documented under a subsequent field action that supersedes the original, in order to ensure accurate tracking and comprehensive resolution of all related tasks.Investigation is in process.A follow-up report will be provided.
Event or Problem Description
The customer reported that during rinseback a rika device alarmed for a non-recoverable alarm, software error and an internal voltage switch error.The device then started to smell of burnt plastic and wire and began to smoke from the back.A service technician checked out the machine at the customer site on (b)(6) 2025.After turning device on the technician noted the device instantly started to spark and visualized fire and smoke next to the interface cca board.No additional evaluation was performed at that time.Patient information is not available at this time.No injury or medical intervention occurred.
Additional Manufacturer Narrative
This report is being filed to provide additional information in h.6 and h.11.Investigation: a service technician checked out the machine at the customer site on 04/30/2025.After turning device on the technician noted the device instantly started to spark and visualized fire and smoke next to the interface cca board.No additional evaluation was performed at that time.On 05/08/2025 a service technician determined the low-pressure relief valve experienced a failure that caused damage to the interface circuit card assembly (cca), the multifunction cca and the gpio harness.All 4 parts and a new air module were removed and replaced.On 05/09/2025 a service technician replaced the gpio cable, the interface cca and multifunction cca.On 5/14/2025 a service technician completed an electrical safety, high- and low-pressure calibration, multifunction auto test and fluid test.All tests had passing results.Three photographs were submitted in lieu of the disposables set to aid in the investigation.Analysis of the images confirmed burn mark and fire next to the interface cca board.It was also noted that the side panels were removed.Based on the preliminary investigation, the cause of thermal events related to the control valve assembly was a short circuit of a capacitor component within the off-the shelf control valve.A thermal event may occur from a sustained overcurrent condition on the high- and low-pressure relief valve control signals.The capacitor shorts because the voltage applied within the valve is higher than the capacitor manufacturer¿s recommendations for a high reliability design.The device serial number history report indicates no further related issues have been reported for this device.One year of service history was reviewed for this device with no issues related to the reported condition identified.Corrective action: based on preliminary investigation performed, the cause of this event is related to a short circuit of a component within the pressure relief valve used in the manufacturing of the finished device.A short circuit of the component may occur when the voltage applied to the pressure valve assembly exceeds the voltage specified.Because this may be observed in all commercialized units of rika plasma donation system a voluntary field action will be initiated.Terumo bct initiated a corrective action and supplier corrective action for this failure to reduce the potential for recurrence.Correction 07/09/2025: terumo blood and cell technologies initiated a voluntary field correction for rika plasma donation systems (catalog number 42000) following identification of a potential issue involving an electrical component within the high-pressure and/or low-pressure control valve.Preliminary findings indicated the issue was related to a short circuit within the pressure relief valve component, which may occur if the voltage applied exceeds the specified range.While the occurrence is limited, the issue could potentially affect all commercialized rika units.As a precautionary measure, a voluntary field action was initiated.Customers were initially notified on 23 may 2025 via a voluntary medical device field correction letter.Following the start of the field correction, additional implementation details required a follow-up communication to customers.This was shared as part of a service message outlining the continuation of the corrective activities.These activities are now being documented under a subsequent field action that supersedes the original, in order to ensure accurate tracking and comprehensive resolution of all related tasks.Root cause: a root cause assessment was performed for this complaint.The cause of the thermal event is a short circuit of a supplied component being used within its specified range.
Event or Problem Description
The customer reported that during rinseback a rika device alarmed for a non-recoverable alarm, software error and an internal voltage switch error.The device then started to smell of burnt plastic and wire and began to smoke from the back.A service technician checked out the machine at the customer site on 04/30/2025.After turning device on the technician noted the device instantly started to spark and visualized fire and smoke next to the interface cca board.No additional evaluation was performed at that time.Patient information is not available.No injury or medical intervention occurred.
Event or Problem Description
The customer reported that during rinseback a rika device alarmed for a non-recoverable alarm, software error and an internal voltage switch error.The device then started to smell of burnt plastic and wire and began to smoke from the back.A service technician checked out the machine at the customer site on (b)(6) 2025.After turning device on the technician noted the device instantly started to spark and visualized fire and smoke next to the interface cca board.No additional evaluation was performed at that time.Patient information is not available at this time.No injury or medical intervention occurred.
Additional Manufacturer Narrative
This report is being filed to provide additional information in h.6 and h.11.Investigation: a service technician checked out the machine at the customer site on (b)(6) 2025.After turning device on the technician noted the device instantly started to spark and visualized fire and smoke next to the interface cca board.No additional evaluation was performed at that time.On 05/08/2025 a service technician determined the low-pressure relief valve experienced a failure that caused damage to the interface circuit card assembly (cca), the multifunction cca and the gpio harness.All 4 parts and a new air module were removed and replaced.On 05/09/2025 a service technician replaced the gpio cable, the interface cca and multifunction cca.On 5/14/2025 a service technician completed an electrical safety, high- and low-pressure calibration, multifunction auto test and fluid test.All tests had passing results.Three photographs were submitted in lieu of the disposables set to aid in the investigation.Analysis of the images confirmed burn mark and fire next to the interface cca board.It was also noted that the side panels were removed.Based on the preliminary investigation, the cause of thermal events related to the control valve assembly was a short circuit of a capacitor component within the off-the shelf control valve.A thermal event may occur from a sustained overcurrent condition on the high- and low-pressure relief valve control signals.The capacitor shorts because the voltage applied within the valve is higher than the capacitor manufacturer¿s recommendations for a high reliability design.The device serial number history report indicates no further related issues have been reported for this device.Corrective action: based on preliminary investigation performed, the cause of this event is related to a short circuit of a component within the pressure relief valve used in the manufacturing of the finished device.A short circuit of the component may occur when the voltage applied to the pressure valve assembly exceeds the voltage specified.Because this may be observed in all commercialized units of rika plasma donation system a voluntary field action will be initiated.Corrective action update 07/09/2025: terumo blood and cell technologies initiated a voluntary field correction for rika plasma donation systems (catalog number 42000) following identification of a potential issue involving an electrical component within the high-pressure and/or low-pressure control valve.Preliminary findings indicated the issue was related to a short circuit within the pressure relief valve component, which may occur if the voltage applied exceeds the specified range.While the occurrence is limited, the issue could potentially affect all commercialized rika units.As a precautionary measure, a voluntary field action was initiated.Customers were initially notified on 23 may 2025 via a voluntary medical device field correction letter.Following the start of the field correction, additional implementation details required a follow-up communication to customers.This was shared as part of a service message outlining the continuation of the corrective activities.These activities are now being documented under a subsequent field action that supersedes the original, in order to ensure accurate tracking and comprehensive resolution of all related tasks.Investigation is in process.A follow-up report will be provided.

• Brand Name: RIKA
• 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: 22073702
• Report Number: 1722028-2025-00133
• Device Sequence Number: 8702320
• Product Code: GKT
• UDI-Device Identifier: 05020583420007
• UDI-Public: 05020583420007
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: BK241097
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 05/22/2025

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: 04/30/2025
• Supplement Date Received by Manufacturer: 06/05/2025; 07/09/2025; 07/24/2025; 09/02/2025
• Initial Report FDA Received Date: 05/22/2025
• Supplement Report FDA Received Date: 06/16/2025; 07/10/2025; 08/04/2025; 09/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2025
• 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