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

Model Number 12220

Device Problems Unexpected Therapeutic Results (1631); No Apparent Adverse Event (3189)

Patient Problems Hemolysis (1886); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/01/2022

Event Type  malfunction  

Manufacturer Narrative

Investigation: per the customer, the replacement fluid was albumin 5%.Remove 25 ml replace 10 ml, acd-a and saline 0.9% used for priming.Investigation is in process, a follow-up report will be provided.

Event Description

The customer reported that a few minutes into a therapeutic plasma exchange (tpe) procedure on a patient with guillen barre, the nurse noticed hemolysis in the channel, connector and inlet line.She stopped the treatment right away.The patient had a blood transfusion previous to the tpe procedure, and the customer thinks that it was a blood transfusion reaction, nothing to do with the tpe.A transfusion panel was ordered by the doctor at the customer site, but the result are not available at this time.Patient id and age are not available from the customer.Per the customer, the patient is stable.The disposables set is not available for return because it was discarded by the customer.

Event Description

The customer reported that a few minutes into a therapeutic plasma exchange (tpe) procedure on a patient with guillen barre, the nurse noticed hemolysis in the channel, connector and inlet line.She stopped the treatment right away.The patient had a blood transfusion previous to the tpe procedure, and the customer thinks that it was a blood transfusion reaction, nothing to do with the tpe.A transfusion panel was ordered by the doctor at the customer site, but the result are not available at this time.Patient id and age are not available from the customer.Per the customer, the patient is stable.The disposables set is not available for return because it was discarded by the customer.

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h.10.Investigation: per the customer, the replacement fluid was albumin 5%.Remove 25 ml replace 10 ml, acd-a and saline 0.9% used for priming.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.The customer doctor stated that it was a post transfusion reaction and no tpe related issues with the exchange component, machine or disposables.The customer does not claim anything wrong with the machine or disposables and patient was stable the same day of procedure.No further reporting will be provided as this does not represent a reportable event.

• 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: 13932559
• MDR Text Key: 298213505
• Report Number: 1722028-2022-00097
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 03/28/2022

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: 01/01/2024
• Device Model Number: 12220
• Device Catalogue Number: 12220
• Device Lot Number: 2201193230
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/03/2022
• Initial Date FDA Received: 03/28/2022
• Supplement Dates Manufacturer Received: 11/30/2022
• Supplement Dates FDA Received: 12/14/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/21/2022
• 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: Female
• Patient Weight: 105 KG