MAUDE Adverse Event Report: TERUMO BCT RIKA; RIKA PLASMA SEPARATION SET

Model Number 21200

Device Problems Use of Device Problem (1670); Insufficient Information (3190); Device Handling Problem (3265)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/17/2022

Event Type  malfunction  

Manufacturer Narrative

Investigation: based on analysis of the sample and dlog, it was determined that the alarm could have been falsely triggered.The alarm occurred during the seventh draw cycle and a return cycle.A visual inspection of the sample was performed and hemolysis was not suspected.The unit was collected (over 500 ml plasma collected) and deemed usable.Investigation is in process.A follow up report will be provided.

Event Description

The customer reported receiving an hemolysis alarm during the 7th draw cycle of a donation procedure.The donor was stable at the time of the incident and leaving the center.Donor was given standard care for cell loss - hydration and observation for 15 minutes at the center.The separation set was not saved by staff.The separation set was discarded and is not being returned.A visual inspection of the separation set was not performed.Per the customer, a visual inspection of the sample was performed.The sample was deemed to not have hemolysis.The unit was deemed usable as hemolysis was not suspected.

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h.10.Investigation: based on analysis of the sample and dlog, it was determined that the alarm could have been falsely triggered.The alarm occurred during the seventh draw cycle and a return cycle.A visual inspection of the sample was performed and hemolysis was not suspected.The unit was collected (over 500 ml plasma collected) and deemed usable.A disposable complaint history search was performed for this lot and there were five other reports for similar issues on this lot.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Correction: the device was returned to service after a return pump autotest and a fluid test were performed successfully.Corrective action: a capa has been initiated.Root cause: a root cause assessment was performed for this complaint.The most likely root cause is the donor physiology such as icteric plasma or lipemic plasma.However, based on the available information, additional possible causes could not be ruled out and include: * an operator misload where the draw pump door was closed on a small section of the tubing on the outlet side, partially occluding the tubing.

Event Description

The customer reported receiving an hemolysis alarm during the 7th draw cycle of a donation procedure.The donor was stable at the time of the incident and leaving the center.Donor was given standard care for cell loss - hydration and observation for 15 minutes at the center.The separation set was not saved by staff.The separation set was discarded and is not being returned.A visual inspection of the separation set was not performed.Per the customer, a visual inspection of the sample was performed.The sample was deemed to not have hemolysis.The unit was deemed usable as hemolysis was not suspected.

• Brand Name: RIKA
• Type of Device: RIKA PLASMA SEPARATION SET
• 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: 15607854
• MDR Text Key: 302355670
• Report Number: 1722028-2022-00341
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583212008
• UDI-Public: 05020583212008
• 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: 10/14/2022

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 Expiration Date: 07/20/2023
• Device Model Number: 21200
• Device Catalogue Number: 21200
• Device Lot Number: 2207201160
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/19/2022
• Initial Date FDA Received: 10/14/2022
• Supplement Dates Manufacturer Received: 12/01/2022
• Supplement Dates FDA Received: 12/02/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/20/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 30 YR
• Patient Sex: Male