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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO BCT RIKA PLASMA DONATION SYSTEM
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TERUMO BCT RIKA PLASMA DONATION SYSTEM Back to Search Results
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 01/30/2024
Event Type  malfunction  
Event Description
The customer reported that during a procedure on a rika device 771 ml of saline was administered instead of the standard 500 ml.The set was examined for kinks and occlusions with none found, the saline bag was fully empty.Patient information and outcome are not available at this time.
 
Manufacturer Narrative
Investigation: a terumo bct service technician performed a recalibration and a cps calibration with failing results due to draw and return pump centrifuge pressure sensor values out of expected range.The technician then performed both draw and return pump cca auto tests with passing results.After those tests passed, the technician installed new tubing and hemostat and performed the cps calibration again.The machine failed due to the centrifuge pressure sensor values out of expected range.The technician transferred a second pressure transducer to the center and attempted the cps calibration again with failing results.Per the service manual, the technician replaced the tubing and verified that the connections were correct and attempted calibration again with failing results.The device was powered on and the technician performed a high pressure sensor calibration, cuff pressure sensor, centrifuge pressure sensor, access pressure sensor, weight station calibration successfully and performed all auto tests with passing results.Investigation is in process, a follow up report will be provided.
 
Event Description
The customer reported that during a procedure on a rika device 771 ml of saline was administered instead of the standard 500 ml.The set was examined for kinks and occlusions with none found, the saline bag was fully empty.Patient information and outcome are not available at this time.
 
Manufacturer Narrative
Investigation: a terumo bct service technician performed a recalibration and a cps calibration with failing results due to draw and return pump centrifuge pressure sensor values out of expected range.The technician then performed both draw and return pump cca auto tests with passing results.After those tests passed, the technician installed new tubing and hemostat and performed the cps calibration again.The machine failed due to the centrifuge pressure sensor values out of expected range.The technician transferred a second pressure transducer to the center and attempted the cps calibration again with failing results.Per the service manual, the technician replaced the tubing and verified that the connections were correct and attempted calibration again with failing results.The device was powered on and the technician performed a high pressure sensor calibration, cuff pressure sensor, centrifuge pressure sensor, access pressure sensor, weight station calibration successfully and performed all auto tests 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 calculated fluid balance was 18.94%.No further reporting will be provided as this does not represent a reportable event.
 
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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 Key18789531
MDR Text Key336976575
Report Number1722028-2024-00064
Device Sequence Number1
Product Code GKT
UDI-Device Identifier05020583420007
UDI-Public05020583420007
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
BK210635
Number of Events Reported1
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 02/27/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/27/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number42000
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/13/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/29/2023
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Other;
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