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

Model Number 21200

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Syncope/Fainting (4411)

Event Date 04/06/2023

Event Type  Injury  

Manufacturer Narrative

Lot number and expiry information are not available at this time.Investigation is in process.A follow-up report will be provided.

Event Description

It was reported that a donor that had completed a donation but re-entered the facility on (b)(6) 2023 around 5:30pm.Center staff said that she collapsed and emt was called.Donor was coherent and communicating with emt and csl staff.She was placed on a stretcher and into an ambulance outside of the facility.Patient information and outcome are unknown at this time.The collection set is not available for return because it was discarded by the customer.

Manufacturer Narrative

Investigation: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.A disposable history search indicated there were no other reported occurrences of adverse reactions on this lot worldwide.The reported adverse events are common side effects of apheresis donations.According to aabb technical manual 16th edition, adverse reactions seen at the time of donation or those reported later average about 3.5% of donations.Reactions that need medical care after the donor has left the donation site are seen in 1 in 34 donors.Vasovagal reaction complex includes dizziness, sweating, nausea, vomiting, weakness, apprehension, pallor, hypotension, and bradycardia.In severe cases, syncope and convulsions may be observed.The pulse rate is often low during vasovagal reactions while the rate is often high during volume depletion.Some donors with severe reactions or those with prolonged recovery times may need short-term observation, intravenous fluid administration in the emergency room, or both.Root cause: a specific root cause for the reported reaction could not be determined.The reported adverse reactions are common side effects of therapeutic apheresis procedures.They are typically caused by fluid shift, blood loss, length of the procedure, donor's sensitivity to the procedure and/or hemodynamic stress of the procedure.

Event Description

It was reported that a donor that had completed a donation but re-entered the facility on (b)(6) 2023 around 5:30pm.Center staff said that she collapsed (loss of consciousness for approximately 60 seconds) and emt was called.The center staff provided first aid according to the center sop including elevating extremities and applied ice packs.Donor was coherent and communicating with emt and csl staff.She was placed on a stretcher and into an ambulance outside of the facility.Full patient id: (b)(6) per follow up from the customer, the donor was treated by emt and released.The donor was not hospitalized and information regarding the treatment provided by ems was not available.A follow up phone call was conducted and the donor reported condition was resolved.The donor has not returned to the center for another donation.Per the customer, donor condition was stable prior to the donation and no medications or treatments administered prior to, during or following the donation.The collection set is not available for return because it was discarded by the customer.

• 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: 16845464
• MDR Text Key: 314305203
• Report Number: 1722028-2023-00160
• 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: 05/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 21200
• Device Catalogue Number: 21200
• Device Lot Number: 2211101261
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/15/2023
• Was Device Evaluated by Manufacturer?: No
• 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: 20 YR
• Patient Sex: Female