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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
Catalog Number 6212001
Device Problems No Apparent Adverse Event (3189); Insufficient Information (3190)
Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/25/2023
Event Type  malfunction  
Event Description
The customer reported that during a procedure on a rika plasma donation system they received the alarm "return pump track is not in position" 6 times while the donor was connected.Per the customer, the separation set was loaded by a newly trained operator.The procedure was ended and while trying to give rinseback there were "software supervisor error" and "non-recoverable procedure error" received , which resulted in prematurely ending the run with no rinseback.The donor was disconnected and given snacks and oral fluids.No medical intervention or adverse events were reported.Patient id, age and gender are not available at this time.
 
Manufacturer Narrative
Investigation: upon run data file (rdf) analysis the 234ml of plasma were collected before the run ended with no saline rinsed back to the donor.Donor information from the dlog is as follows: hct=40 weight=216lb.Total blood volume (tbv) calculation was based on assumed height of 4'.Female = 4070 ml tbv.234ml of plasma collected and 200ml of blood left in the channel = 434ml fluid removed from donor.The disposables set was returned to tbct for evaluation.A small dent was found in the return pump line of the separation set.This dent lines up with and is consistent with kinking of the separation set¿s return pump line tubing in the return pump.Through dlog investigation the tbct system engineer found no signs of high pressure or under delivery caused by this kink in the line, in which most likely only plasma passed through at the time of kinking.Photos taken of the pump did not indicate any loading error and the spot where the kink was located is not visible in the photo provided.When watching the same operator load on 31jul2023, it was noticed that she loaded the return pump before loading the collection manifold in a left to right motion, however, tbct is unable to confirm sequence in which the set was loaded on the day of the dd.Operators are taught in class that best practice is to load the collection manifold before loading the return pump and the device operator¿s manual instructs the operator to load the return pump from right to left.Loading in the return pump before the collection manifold is known to cause excess tubing and therefore kinks in the return pump.Therefore, even though it cannot be confirmed a deviation from best practice occurred, for clarification purposes, retraining of set loading is indicated.During investigation, a gap in the software protocol was found where the device can get stuck in a state at the beginning of rinseback if the pump tracks or valves are not working properly.The supervisor alarm stepped in as designed when the protocol did not advance as intended.Before the device was run again, a tbct system engineer went out to the site for a service inspection on 27jul2023.They were able to open and close the pump track without any noticeable interference, hang up, or friction.The device was determined to be working correctly, and paired with the findings on the set; the evidence suggests the issue may have been caused by incorrect operator loading.An email notification was sent by the terumo bct on 28jul2023, to inform the site supervisor and research staff that the device was cleared to use.Investigation is in process, a follow-up report will be provided.
 
Event Description
The customer reported that during a procedure on a rika plasma donation system they received the alarm "return pump track is not in position" 6 times while the donor was connected.Per the customer, the separation set was loaded by a newly trained operator.The procedure was ended and while trying to give rinseback there were "software supervisor error" and "non-recoverable procedure error" received , which resulted in prematurely ending the run with no rinseback.The donor was disconnected and given snacks and oral fluids.No medical intervention or adverse events were reported.Patient id, age and gender are not available at this time.
 
Manufacturer Narrative
Investigation: upon run data file (rdf) analysis the 234ml of plasma were collected before the run ended with no saline rinsed back to the donor.Donor information from the dlog is as follows: hct=40 weight=216lb.Total blood volume (tbv) calculation was based on assumed height of 4'.Female = 4070 ml tbv.234ml of plasma collected and 200ml of blood left in the channel = 434ml fluid removed from donor.The disposables set was returned to tbct for evaluation.A small dent was found in the return pump line of the separation set.This dent lines up with and is consistent with kinking of the separation set's return pump line tubing in the return pump.Through dlog investigation the tbct system engineer found no signs of high pressure or under delivery caused by this kink in the line, in which most likely only plasma passed through at the time of kinking.Photos taken of the pump did not indicate any loading error and the spot where the kink was located is not visible in the photo provided.When watching the same operator load on (b)(6) 2023, it was noticed that she loaded the return pump before loading the collection manifold in a left to right motion, however, tbct is unable to confirm sequence in which the set was loaded on the day of the dd.Operators are taught in class that best practice is to load the collection manifold before loading the return pump and the device operator's manual instructs the operator to load the return pump from right to left.Loading in the return pump before the collection manifold is known to cause excess tubing and therefore kinks in the return pump.Therefore, even though it cannot be confirmed a deviation from best practice occurred, for clarification purposes, retraining of set loading is indicated.During investigation, a gap in the software protocol was found where the device can get stuck in a state at the beginning of rinseback if the pump tracks or valves are not working properly.The supervisor alarm stepped in as designed when the protocol did not advance as intended.Before the device was run again, a tbct system engineer went out to the site for a service inspection on 27jul2023.They were able to open and close the pump track without any noticeable interference, hang up, or friction.The device was determined to be working correctly, and paired with the findings on the set; the evidence suggests the issue may have been caused by incorrect operator loading.An email notification was sent by the terumo bct on 28jul2023, to inform the site supervisor and research staff that the device was cleared to use.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 calculation of the final fluid balance is below the 20% reportable limit.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 Key18669145
MDR Text Key335753695
Report Number1722028-2024-00043
Device Sequence Number1
Product Code GKT
UDI-Device Identifier05020583212008
UDI-Public05020583212008
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 02/08/2024
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 Catalogue Number6212001
Device Lot Number2210151161
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/15/2024
Initial Date FDA Received02/08/2024
Supplement Dates Manufacturer Received02/28/2024
Supplement Dates FDA Received03/04/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/12/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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