MAUDE Adverse Event Report: TERUMO BCT SPECTRA OPTIA; SPECTRA OPTIA EXCHANGE SET

Model Number 12220

Device Problems Unexpected Therapeutic Results (1631); Infusion or Flow Problem (2964); No Apparent Adverse Event (3189)

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

Event Date 02/24/2022

Event Type  malfunction  

Manufacturer Narrative

Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported the alarm cells were detected in plasma line from centrifuge.The plasma in the connector is discolored cherry color during a red blood cell exchange (rbcx) procedure on a sickle cell patient.Terumo bct customer support asked the operator to pause the machine and call the locations dr.The dr.Ordered a transfusion panel reaction test, the lab did not see any hemolysis from the pre cbc.Per follow up from the customer, the dr.Cancelled the transfusion reaction panel and the dr.Sent the patient home, the patient will come back next month for a rbcx procedure.The customer stated that the dr.Was not worried about the hemolysis levels in the disposable set.Per the customer the patient is stable the collection set is not available for return because it was discarded by the customer.Investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information in h6 and h10.Investigation: 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 the customer, they experience some hemolysis every time the patient comes for the rbcx treatment and they believe it is due to poor access from the vortex port and progression of disease.Hemolysis was observed in the connector two hours into the procedure.The device alarmed ¿cells were detected in plasma line from centrifuge¿.A doctor ordered a transfusion reaction panel.The customer informed clinical support that the doctor cancelled the transfusion reaction panel and sent the patient home.The doctor was not worried about the hemolysis levels in the set.The customer reported that they had a lot of problems with the vortex port previously and was told by the rest of the nurses that deal with the same patient every four weeks that they experience some hemolysis every time the patient comes in for rbx treatment.The nurses believe the hemolysis is due to poor access from the vortex port and progression of the disease.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.No further reporting will be provided as this does not represent a reportable event.

Event Description

The customer would like the following run data file investigated to determine a possible cause for the higher-than-expected wbc content in the platelet product.Donor unit #: (b)(6) there was not a transfusion recipient or patient involved at the time of the residual wbc testing, therefore no patient information is reasonably known at the time of the event.The platelet collection set is not available for return because it was discarded by the customer.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE 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: 13841225
• MDR Text Key: 297869245
• Report Number: 1722028-2022-00090
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583122208
• UDI-Public: 35020583122209
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK150251
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/21/2022

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: 02/01/2024
• Device Model Number: 12220
• Device Catalogue Number: 12220
• Device Lot Number: 2202023130
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/24/2022
• Initial Date FDA Received: 03/21/2022
• Supplement Dates Manufacturer Received: 11/30/2022
• Supplement Dates FDA Received: 12/09/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/03/2022
• 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 Sex: Male
• Patient Weight: 107 KG