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

Model Number 10220

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cough (4457); Wheezing (4463)

Event Date 05/18/2021

Event Type  Injury  

Manufacturer Narrative

Device lot #, manufacture date and expiry are not available at this time.Investigation is in process, a follow-up report will be provided.

Event Description

The customer reported that towards the end of a procedure, the patient developed a cough and wheezing.The procedure was paused and the physician wanted to medicate the patient and see how the patient responded and continue with the procedure.It was unknown how long the procedure was paused.Per the customer, a blood transfusion reaction workup, blood cultures, complete blood count (cbc), chest xray, benadryl 12.5 mg and solumedrol 60 mg iv were administered and the patient is in stable condition.The set is not available for return because it was discarded by the customer.

Event Description

The customer reported that towards the end of a procedure, the patient developed a cough and wheezing.The procedure was paused and the physician wanted to medicate the patient and see how the patient responded and continue with the procedure.It was unknown how long the procedure was paused.Per the customer, a blood tx reaction workup, blood cultures, cbc, chest xray, benadryl 12.5 mg and solumedrol 60 mg iv were administered and the patient is in stable condition.The 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 d.4, h.6 and h.10.Investigation: the patient presented with diagnosis of thrombotic thrombocytopenic purpura (ttp)/atypical hemolytic-uremic syndrome (hus) underwent tpe.Prior to the procedure the patient was described as visually stable.Tylenol 650 mg and benadryl 25 mg were administered as part of the planned protocol.The patient developed a cough and wheezing close to the end of the run.The physician wanted to medicate the patient and see how the patient responded and continue with the procedure.The physician ordered blood transfusion reaction workup, blood cultures, cbc, chest x-ray.The medical intervention also included unplanned prescription medication, specifically benadryl 12.5 mg and solumedrol 60 mg iv were prescribed by the physician due to the patient's cough and wheezing.The patient was described as stable following the treatment.The customer wanted to know if they could take the patient off and start over with another kit for the remainder of the fluid.Terumo bct clinical support advised the customer they didn't have enough remaining fluid and that they could set up another disposable set for the remainder of the fluid and confirmed we didn't have a protocol to resume the procedure after the centrifuge had been stopped for 10 minutes.At this point it was unknown how long the procedure would be paused.The nurse would have to defer to the physician for further instructions.The procedure was paused and they were going to get in touch with the physician the lot number was not provided, therefore, a dhr search could not be conducted for this specific incident.All lots must meet acceptance criteria for release according to therapeutic apheresis: a physician's handbook, adverse events occur during therapeutic procedures with a frequency of 4.8%.Symptoms of these allergic reactions may include hives, dyspnea, wheezing, burning eyes, tachycardia, hypotension, and or facial swelling and flushing.Mild reactions can be treated with diphenhydramine administered through an iv.Root cause: a definitive root cause for the patient's reaction could not be determined.Possible causes for the patient's reaction include but are not limited to an allergy to replacement solution and/or patient sensitivity to eto.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE SET
• Manufacturer (Section D): TERUMO BCT; 10810 w. collins ave; 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 ; 3032314970
• MDR Report Key: 11967013
• MDR Text Key: 255340728
• Report Number: 1722028-2021-00200
• Device Sequence Number: 1
• Product Code: LKN
• UDI-Device Identifier: 05020583102200
• UDI-Public: 05020583102200
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10220
• Device Catalogue Number: 10220
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/20/2021
• Initial Date FDA Received: 06/09/2021
• Supplement Dates Manufacturer Received: 04/01/2022
• Supplement Dates FDA Received: 04/07/2022
• 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): Required Intervention; Other
• Patient Age: 22 YR
• Patient Sex: Female
• Patient Weight: 54 KG