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

Model Number 10220

Device Problems Insufficient Flow or Under Infusion (2182); Adverse Event Without Identified Device or Use Problem (2993); Protective Measures Problem (3015)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/11/2021

Event Type  Injury  

Event Description

The customer reported that a red blood cell depletion/exchange (rbcx/d) procedure on a sickle cell patient did not meet the target end hematocrit of 32%, resulting in a post hematocrit of 26%.The customer reported that they experience cells detected in plasma line from centrifuge alarms.The physician required a full rinseback.The patient required a blood transfusion post procedure as a result.Per the customer, the patient was in good condition prior to the procedure.The patient was on benadryl (50 mg iv) prior to the procedure and received 2 additional units of blood.The disposables set is not available for return because it was discarded by the customer.

Manufacturer Narrative

Lot number, manufacture date and expiration date not available at this time.Investigation: per follow-up with the customer, the replacement product used were washed rbc's and they entered a hct of 80%.Investigation is in process, a follow-up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information in b6 and h6.Corrected information is provided in b3.Lot number, manufacture date and expiry date not available at this time.Investigation: per follow-up with the customer, the replacement product used were washed rbc's and they entered a hct of 80%.The run data file (rdf) was analyzed for this event.The pumps operated within the normal limits and there were no abnormalities in the pressure or level (reservoir) sensor readings.Review of the rdf and images for the customer complaint did not indicate an issue with the procedure.The procedure operated as intended.The estimated patient hct at the end of the procedure was 26%.Typical reasons for error between the final patient hct that the optia system reports and what is measured may be due to errors in replacement fluid hct, measured patient hct, errors in measurement, blood counter discrepancies¿etc.For optimal results it is best to obtain the hct and volume of each unit of replacement rbc and then average the hct of the units and enter the averaged value during data entry.If the patients hct is entered falsely low, or the replace fluid hct is entered falsely low, this can lead to a higher than expected patient end hct.Entry of incorrect values will result in incorrect end targets.The outcome of the procedure depends on the accuracy of the data entered.Review of the files and associated images for this procedure also showed the presence of minor clumping in the connector during the run, worsening as the run proceeded.The inlet:ac ratio was set to 13:1 at the beginning of the procedure.The inlet:ac ratio was never decreased during the procedure.In general, the likelihood for platelet clumping to occur during a run is difficult to predict since it is not dependent on a specific platelet count and varies by patient.For that reason, every procedure should be observed for clumping in the connector and the collect port.If a clump is observed or suspected, it is best to eliminate it and stop the clotting cascade as quickly as possible by reducing the inlet:ac ratio to 8:1.Once a clump has been resolved, a ratio that maintains adequate separation should be used which may be lower than initially set to ensure adequate anticoagulation.The inlet:ac ratio was set at a value of 13:1 and not properly adjusted during this run.If clumping persists or worsens, especially after a lower inlet:ac ratio has been entered, it is recommended to verify that ac fluid is flowing into the drip chamber to ensure proper anticoagulation of the set.For more information on managing ac, refer to the section of called ¿managing anticoagulation of the extracorporeal circuit¿ in the ¿troubleshooting¿ section in the spectra optia apheresis system operator¿s manual.Investigation is in process, a follow-up report will be provided.

Event Description

The customer reported that a red blood cell depletion/exchange (rbcx/d) procedure on a sickle cell patient did not meet the target end hematocrit of 32%, resulting in a post hematocrit of 26%.The customer reported that they experience cells detected in plasma line from centrifuge" alarms.The physician required a full rinseback.The patient required a blood transfusion post procedure as a result.Per the customer, the patient was in good condition prior to the procedure.The patient was on benadryl (50 mg iv) prior to the procedure and received 2 additional units of blood.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 follow-up with the customer, the replacement product used were washed rbc's and they entered a hct of 80%.The run data file (rdf) was analyzed for this event.The pumps operated within the normal limits and there were no abnormalities in the pressure or level (reservoir) sensor readings.Review of the rdf and images for the customer complaint did not indicate an issue with the procedure.The procedure operated as intended.The estimated patient hct at the end of the procedure was 26%.Typical reasons for error between the final patient hct that the optia system reports and what is measured may be due to errors in replacement fluid hct, measured patient hct, errors in measurement, blood counter discrepancies¿etc.For optimal results it is best to obtain the hct and volume of each unit of replacement rbc and then average the hct of the units and enter the averaged value during data entry.If the patients hct is entered falsely low, or the replace fluid hct is entered falsely low, this can lead to a higher than expected patient end hct.Entry of incorrect values will result in incorrect end targets.The outcome of the procedure depends on the accuracy of the data entered.Review of the files and associated images for this procedure also showed the presence of minor clumping in the connector during the run, worsening as the run proceeded.The inlet:ac ratio was set to 13:1 at the beginning of the procedure.The inlet:ac ratio was never decreased during the procedure.In general, the likelihood for platelet clumping to occur during a run is difficult to predict since it is not dependent on a specific platelet count and varies by patient.For that reason, every procedure should be observed for clumping in the connector and the collect port.If a clump is observed or suspected, it is best to eliminate it and stop the clotting cascade as quickly as possible by reducing the inlet:ac ratio to 8:1.Once a clump has been resolved, a ratio that maintains adequate separation should be used which may be lower than initially set to ensure adequate anticoagulation.The inlet:ac ratio was set at a value of 13:1 and not properly adjusted during this run.If clumping persists or worsens, especially after a lower inlet:ac ratio has been entered, it is recommended to verify that ac fluid is flowing into the drip chamber to ensure proper anticoagulation of the set.For more information on managing ac, refer to the section of called ¿managing anticoagulation of the extracorporeal circuit¿ in the ¿troubleshooting¿ section in the spectra optia apheresis system operator¿s manual.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.Root cause: a root cause assessment was performed for this complaint.Based on the available information a definitive root cause for the lower than expected patient post hct was undetermined but may be related to operator incorrect data entry and/or blood counter discrepancy.

Event Description

The customer reported that a red blood cell depletion/exchange (rbcx/d) procedure on a sickle cell patient did not meet the target end hematocrit of 32%, resulting in a post hematocrit of 26%.The customer reported that they experience cells detected in plasma line from centrifuge" alarms.The physician required a full rinseback.The patient required a blood transfusion post procedure as a result.Per the customer, the patient was in good condition prior to the procedure.The patient was on benadryl (50 mg iv) prior to the procedure and received 2 additional units of blood.The disposables 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: 12975933
• MDR Text Key: 284892210
• Report Number: 1722028-2021-00384
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date: 12/10/2021

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
• Device Lot Number: 2109023230
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/15/2021
• Initial Date FDA Received: 12/10/2021
• Supplement Dates Manufacturer Received: 12/13/2021; 01/05/2023
• Supplement Dates FDA Received: 01/04/2022; 01/05/2023
• 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): Other; Required Intervention
• Patient Age: 14 YR
• Patient Sex: Female
• Patient Weight: 66 KG