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

Catalog Number 12220

Device Problems Contamination of Device Ingredient or Reagent (2901); No Apparent Adverse Event (3189)

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

Event Date 05/27/2022

Event Type  Injury  

Event Description

The customer reported hemolysis during a therapeutic plasma exchange (tpe) procedure.A t 13 minutes, the operator received the 'cells detected in plasma line in centrifuge' alarm and noted pink plasma in the wasted bag and connector.The operator confirmed solutions were hanging correctly.Cmp, cbc, clotting factors testing was performed, the results are not currently available.Patient is inpatient and stable.The device is not available for return because it was discarded by the customer.

Manufacturer Narrative

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

Manufacturer Narrative

This report is being filed to provide additional information in h.6.And h.10.Investigation: per the customer, the patient was given an iron infusion of 1000 mg on (b)(6) 2022, before the procedure.The customer does not suspect true hemolysis.Investigation is in process, a follow-up report will be provided.

Event Description

The customer reported hemolysis during a therapeutic plasma exchange (tpe) procedure.A t 13 minutes, the operator received the 'cells detected in plasma line in centrifuge' alarm and noted pink plasma in the wasted bag and connector.The operator confirmed solutions were hanging correctly.Cmp, cbc, clotting factors testing was performed, the results are not currently available.Patient is inpatient and stable.The device is not available for return because it was discarded by the customer.

Manufacturer Narrative

Investigation: per the customer, the patient was given an iron infusion of 1000 mg on (b)(6) 2022, before the procedure.The customer does not suspect true hemolysis.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, the patient had a iron infusion 1,000 mg prior to apheresis.They believe this is what caused the color change and not true hemolysis.No further reporting will be provided as this does not represent a reportable event.

Event Description

The customer reported hemolysis during a therapeutic plasma exchange (tpe) procedure.A t 13 minutes, the operator received the 'cells detected in plasma line in centrifuge' alarm and noted pink plasma in the wasted bag and connector.The operator confirmed solutions were hanging correctly.Cmp, cbc, clotting factors testing was performed, the results are not currently available.Patient is inpatient and stable.The device is not available for return because it was discarded by the customer.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE SET,EA
• 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: 14755859
• MDR Text Key: 295048483
• Report Number: 1722028-2022-00202
• Device Sequence Number: 1
• Product Code: GKT
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/21/2022

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: 04/01/2024
• Device Catalogue Number: 12220
• Device Lot Number: 2204043230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/27/2022
• Initial Date FDA Received: 06/21/2022
• Supplement Dates Manufacturer Received: 08/24/2022; 04/19/2023
• Supplement Dates FDA Received: 09/02/2022; 04/19/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/04/2022
• 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; Required Intervention
• Patient Age: 44 YR
• Patient Sex: Female
• Patient Weight: 65 KG