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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 Hypovolemia (2243); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/11/2024
Event Type  malfunction  
Event Description
The customer reported that during a procedure on a rika device, saline was not infused completely.No medical intervention was reported.Patient information and outcome are not available at this time.
 
Manufacturer Narrative
Investigation: a terumo bct service technician checked out the device at the customer site and performed a multifunction cca auto test and fluid test with passing results.The technician evaluated the device, dual valve, return pump, and the draw pump, all were working as expected.Investigation is in process.A follow-up report will be provided.
 
Manufacturer Narrative
Investigation: a terumo bct service technician checked out the device at the customer site and performed a multifunction cca auto test and fluid test with passing results.The technician evaluated the device, dual valve, return pump, and the draw pump, all were working as expected.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 procedure on a rika device, saline was not infused completely.No medical intervention was reported.Patient information and outcome are not available at this time.
 
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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 Key19042027
MDR Text Key340110162
Report Number1722028-2024-00115
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 04/04/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/04/2024
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 Received04/17/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/21/2023
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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