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

Model Number 10310

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

Patient Problems Chest Pain (1776); Chills (2191); Abdominal Cramps (2543)

Event Date 01/20/2022

Event Type  Injury  

Event Description

The customer reported that approximately 103 min into a platelet depletion procedure (pltd) on optia for a previously admitted patient, they reported that the patient had abdominal cramps, chills and a feeling of heaviness in the chest.They had a pulse of 120 times/minute, lungs were clear and spo2 96 % and limbs were cold.This time the patient was admitted to the hospital because of an elevated platelet count (3026 g/l), with an indication for treatment of platelets depletion.They treated according to the anaphylactic emergency protocol and sent a request to consult to intensive care, allergy - clinical immunology.The patient was stable and they continued to maintain the adrenaline dose of 0.05 mcg/kg/min.Pulse was 90 beats/min, blood pressure: 110/70 mmhg, chills were gone, no chest pain, no shortness of breath.The following day, the patient was stable and still maintaining adrenaline 0.05 mcg/kg/min.The platelet depletion set is not available for return because it was discarded by the customer.

Manufacturer Narrative

Investigation: per the customer, the system, the depletion set and the acda bag showed no abnormal signs.The doctor performed the depletion procedure according to the correct procedure.Acda, batch number 20bc6039, expiry date 9/2022.The customer provided photographs of the tyvek optia idl set for investigation.The photos confirmed the batch details as reported.The customer also provided the patients' pre and post lab data including cbc, comprehensive metabolic panel, coagulation panel, procalcitonin and troponin tests.The values that are outside of normal ranges are listed below: pre/post lab data ((b)(6) 2022 18:55/21:42): pre hct 0.34 pre mcv 106.5 pre rdw-cv 18.0 pre plt 3026 posture 8.4 post calcitoanphan 2.12 post albumin 32.9 post lactic acid 3.75 post procalcitonin 0.041 a disposable complaint history search was performed for this lot and found no reports for similar issues on this lot worldwide.The batch documentation was review for acd-a batch 20bc6039, no issues were noted.The correct chemicals and formula were used for the bulk fluid solution and no issues were identified at sterilisation.All qc finished goods testing were within specification.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.The run data file (rdf) was analyzed for this event.Based on a review of the signals in the rdf for this procedure, there is no evidence or suspicion of device malfunction for the reported patient reaction.Per the complaint description, the procedure ran for approximately 100 minutes before the onset of the patient¿s symptoms and was ended shortly after by the operator.Throughout the duration of the procedure, changes were made to inlet flow rate and collection preference, but all other signals indicated the procedure ran as designed.Of note is that the option for replacement fluid was selected as none during procedure setup.Depletion procedures use the entered platelet count to calculate the default collect pump flow rate.The higher the platelet count, the faster the default collect pump flow rate will be.Higher collect pump flow rates result in removal of larger volumes of fluid, which can in turn cause fluid balance shifts in a patient.In this specific case, the fluid balance of the patient at the time of the reported reaction was approximately 92%.Rinseback was performed, leaving the final patient fluid balance at 95%.While a definitive root cause cannot be determined from the dlog, individual patient tolerance to fluid balance shifts during a procedure should be considered as a possible cause.The spectra optia operator¿s manual provides a warning statement regarding the presence of residual ethylene oxide (eo) in tubing sets and the potential to cause an allergic reaction.If a patient has a known allergy or a suspected allergy to eo, consider performing a saline rinse prior to connecting the patient.Refer to ¿selecting and performing a saline rinse¿ in the operator¿s manual for additional details and instructions.Individual patient tolerance to fluid balance shifts during depletion procedures varies from patient to patient.The platelet depletion procedure on spectra optia does provide an option to deliver replacement fluid throughout the course of a procedure to minimize these effects if necessary (note: the use of replacement fluid is required if the patient¿s fluid balance is calculated to drop below 70%).The decision to deliver replacement fluid should be left to the treating physician and based on individual patient needs.For more information on use of replacement fluid during platelet depletion procedures, please refer to the section on ¿white blood cell depletion (wbcd) and platelet depletion (pltd) procedures¿ in the spectra optia operator¿s manual.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.This product has been processed with eto to achieve a 10-6 sterility assurance level in accordance with en iso 11135.This product has been validated to achieve less than 6mg eto, meeting the requirements of iso 10993-7 prior to release and less then 1ppm in the collect bag at time of use.All sterilization requirements passed.Root cause: based on a review of the signals in the dlog for this procedure, there is no evidence or suspicion of device malfunction for the reported patient reaction.Per the complaint description, the procedure ran for approximately 100 minutes before the onset of the patient¿s symptoms and was ended shortly after by the operator.Throughout the duration of the procedure, changes were made to inlet flow rate and collection preference, but all other signals indicated the procedure ran as designed.Of note is that the option for replacement fluid was selected as none during procedure setup.Depletion procedures use the entered platelet count to calculate the default collect pump flow rate.The higher the platelet count, the faster the default collect pump flow rate will be.Higher collect pump flow rates result in removal of larger volumes of fluid, which can in turn cause fluid balance shifts in a patient.In this specific case, the fluid balance of the patient at the time of the reported reaction was approximately 92%.Rinseback was performed, leaving the final patient fluid balance at 95%.While a definitive root cause cannot be determined from the dlog, individual patient tolerance to fluid balance shifts during a procedure should be considered as a possible cause.The patient's elevated procalcitonin and troponin levels may implicate the patient¿s physiology and/or underlying disease state.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA IDL 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: 13538392
• MDR Text Key: 286864372
• Report Number: 1722028-2022-00046
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583103108
• UDI-Public: 05020583103108
• Combination Product (y/n): N
• Reporter Country Code: VM
• PMA/PMN Number: BK150251
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2023
• Device Model Number: 10310
• Device Catalogue Number: 10310
• Device Lot Number: 2104083130
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/21/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/09/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 45 KG