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 Hypervolemia (2664); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/12/2024

Event Type  malfunction  

Manufacturer Narrative

Investigation: a terumo bct technician performed a dual-valve replacement with weight station calibration followed by performing a dual-valve auto test and fluid test with passing results.A collection procedure mocked with estimated saline volume of 500 ml at the collection summary was successfully completed.Investigation is in process, a follow-up report will be provided.

Event Description

The customer reported that at the end of a collection on the run summary it showed estimated saline volume as 771ml and the target volume was 500ml.Patient information and outcome are unknown at this time.

Manufacturer Narrative

Invesitgation: a terumo bct technician performed a dual-valve replacement with weight station calibration followed by performing a dual-valve auto test and fluid test with passing results.A collection procedure mocked with estimated saline volume of 500 ml at the collection summary was successfully completed.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 at the end of a collection on the run summary it showed estimated saline volume as 771ml and the target volume was 500ml.Patient information and outcome are unknown at this time.

• 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: 19044482
• MDR Text Key: 340110081
• Report Number: 1722028-2024-00121
• 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: 04/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2024
• 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: 04/17/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/11/2023
• 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