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); Incontinence (1928); Nausea (1970); Vomiting (2144); Chills (2191)

Event Date 01/19/2022

Event Type  Injury  

Event Description

The customer reported that approximately 12 min into a platelet depletion procedure (pltd) on optia for a previously admitted patient, they reported that the patient appeared nervous and experienced chest tightness, nausea, vomiting of yellow fluid, bowel incontinence and chills.They had a temperature of 36.5 degrees and bradycardia 57 times / min.Per the customer the pulmonary was clear and the patient's oxygen level was spo2 96%.The reported diagnosis was critical anaphylaxis on platelets/monitoring primary thrombocythemia ¿ rheumatoid arthritis rf positive ¿ type 2 diabetes ¿ hypertension.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 adrenalin.The chest pain and chills stopped.0.15 mcg/kg/min, pulse 110 times/min, bp: 100/60 mmhg, spo2 95%.Currently, the patient is stable and has stopped adrenaline.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 19:42 / (b)(6) 2022 12:30): hct 0.31/0.248 rdw-cv 16.4/16.7 plt 1160/735 wbc 12.12/17.0 ast 115/88 alt 98/69 pre crp 0.644 lactic acid 4.91/5.5 post glucose 10.6 post calcitoanphan 2.0 post albumin 27.9 troponin 23.66 procalcitonin 0.158 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 the procedure there is no evidence or suspicion of device malfunction for the reported patient reaction.Per the complaint description, the patient reaction began 12 minutes into the run.The procedure only ran for 31 minutes before the pause button was pressed and then ended by the operator shortly thereafter.Changes were made to inlet flow rate and collection preference, and the option for replacement fluid was selected as none.All other signals indicated the procedure ran as designed.Definitive root cause cannot be determined from rdf analysis and lab data; however, the reaction early in the run may be indicative of an allergy to the ethylene oxide that is used to sterilize spectra optia tubing sets and/or the patient¿s underlying disease state.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.Investigation is in process.A follow-up report will be provided.

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 (18/01/22 19:42/19/01/22 12:30): hct 0.31/0.248 rdw-cv 16.4/16.7 plt 1160/735 wbc 12.12/17.0 ast 115/88 alt 98/69 pre crp 0.644 lactic acid 4.91/5.5 post glucose 10.6 post calcitoanphan 2.0 post albumin 27.9 troponin 23.66 procalcitonin 0.158 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 the procedure there is no evidence or suspicion of device malfunction for the reported patient reaction.Per the complaint description, the patient reaction began 12 minutes into the run.The procedure only ran for 31 minutes before the pause button was pressed and then ended by the operator shortly thereafter.Changes were made to inlet flow rate and collection preference, and the option for replacement fluid was selected as none.All other signals indicated the procedure ran as designed.Definitive root cause cannot be determined from rdf analysis and lab data; however, the reaction early in the run may be indicative of an allergy to the ethylene oxide that is used to sterilize spectra optia tubing sets and/or the patient¿s underlying disease state.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 patient reaction began 12 minutes into the run.The procedure only ran for 31 minutes before the pause button was pressed and then ended by the operator shortly thereafter.Changes were made to inlet flow rate and collection preference, and the option for replacement fluid was selected as none.All other signals indicated the procedure ran as designed.Definitive root cause cannot be determined from dlog analysis and lab data; however, the reaction early in the run may be indicative of an allergy to the ethylene oxide that is used to sterilize spectra optia tubing sets and/or the patient¿s underlying disease state.

Event Description

The customer reported that approximately 12 min into a platelet depletion procedure (pltd) on optia for a previously admitted patient, they reported that the patient appeared nervous and experienced chest tightness, nausea, vomiting of yellow fluid, bowel incontinence and chills.They had a temperature of 36.5 degrees and bradycardia 57 times / min.Per the customer the pulmonary was clear and the patient's oxygen level was spo2 96%.The reported diagnosis was critical anaphylaxis on platelets/monitoring primary thrombocythemia ¿ rheumatoid arthritis rf positive ¿ type 2 diabetes ¿ hypertension.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 adrenalin.The chest pain and chills stopped.0.15 mcg/kg/min, pulse 110 times/min, bp: 100/60 mmhg, spo2 95%.Currently, the patient is stable and has stopped adrenaline.The platelet depletion set is not available for return because it was discarded by the customer.

• 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: 13536026
• MDR Text Key: 287926484
• Report Number: 1722028-2022-00045
• 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,Followup
• 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: 02/15/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/09/2021
• 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: 63 YR
• Patient Sex: Female
• Patient Weight: 50 KG