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

Model Number 12220

Device Problems No Apparent Adverse Event (3189); Insufficient Information (3190)

Patient Problems Tachycardia (2095); Alteration in Body Temperature (4568)

Event Date 06/16/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The customer sent a request to terumo bct customer support requesting a machine check out because there was a patient blood reaction during a red blood cell exchange (rbcx) procedure.The physician stopped the procedure and was going to do a transfusion work up.The patient experienced elevated heart (hr) rate and temperature (t).During the procedure the hr was 170 and the t was 38.6 c and prior to the procedure hr was 140 and t was 36.9 c.The patient was given tylenol 650 mg, aspirin 325 mg, and benadryl 25 mg.The patient is in stable condition.The collection 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 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.It was confirmed that no unplanned prescription medication was given.No further reporting will be provided as this does not represent a reportable event.A disposable complaint history search was performed for this lot and found no reports for similar issues on this lot worldwide.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Per follow up from the customer, the physician ordered the procedure to be stopped and a transfusion work up was ordered, blood and urine cultures were drawn and the results from the lab were negative.No unplanned prescription medication was given.Root cause: a root cause assessment was performed for this complaint.Based on the available information a definitive root cause could not be determined but it is likely due to one or a combination of the possible causes listed below: * patient physiology/disease state * febrile reactions occur more frequently in patients receiving non-leukocyte-reduced components and those previously alloimunized by transfusion or pregnancy.It is likely the reactions were caused by the presence of recipient antibodies (raised as a result of previous transfusions) reacting to donor human leucocyte antigens (hla) or other antigens.It is also widely known that febrile reactions are caused by passively transfused cytokines or recipient antibodies reacting with leukocytes in the blood product.

Event Description

The customer sent a request to terumo bct customer support requesting a machine check out because there was a patient blood reaction during a red blood cell exchange (rbcx) procedure.The physician stopped the procedure and was going to do a transfusion work up.The patient experienced elevated heart (hr) rate and temperature (t).During the procedure the hr was 170 and the t was 38.6 c and prior to the procedure hr was 140 and t was 36.9 c.The patient was given tylenol 650 mg, aspirin 325 mg, and benadryl 25 mg.The patient is in stable condition.The 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: 17342289
• MDR Text Key: 319377696
• Report Number: 1722028-2023-00240
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183081
• 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: 07/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 12220
• Device Catalogue Number: 4122201
• Device Lot Number: 2302223141
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/20/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/22/2023
• 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): Required Intervention
• Patient Age: 33 YR
• Patient Sex: Male
• Patient Weight: 79 KG