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

Model Number 12320

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Output Problem (3005)

Patient Problem Fever (1858)

Event Date 10/27/2021

Event Type  Injury  

Manufacturer Narrative

Lot number, manufacturer date and expiry information are not available at this time.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that during a continuous mononuclear cell (cmnc) collection on a pediatric patient the color in the collect line was too light.The operator did a blood prime but noticed the saline was left open.This was a 1 liter bag and there was approximately 600 mls left in the bag.The operator reported that about 55 minutes into the run and it was still establishing initial interface.Per the customer, the cp was lowered from 50 to 28 and the color in the collect port was still pink.The alarms that were reported during the run were interface took too long to establish and there was no troubleshooting done.Terumo bct support had the operator lower the original patient hct from 21 down to 18.Support had the customer wait about 5 min.During this time the customer had the alarm again.After 5 min there was no change in the interface and the color.Terumo bct support had the operator lower the patient hct down to 15.Per follow up from the customer they ended the procedure early because the patient spiked a temperature of 100.4.They processed 2.8 liters out of the original order of 3 liters.The patient tbv is 1200 mls.There was no rinse back and the final fb was 112%.Prior to the procedure the patient had radiation therapy with some type of anesthesia.The customer reported that the patient received an unknown antibiotic, blood cultures of rij shiley apheresis catheter & portacath.The blood cultures from the portacath and rij cath were negative.The patient was reported as stable, afreible.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.Investigation: per follow up with the customer the patient received a planned transfusion approx.8 to 10 hrs post collection (in preparation for a surgical procedure).The transfusion was not a direct result of the diluted custom prime.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that during a continuous mononuclear cell (cmnc) collection on a pediatric patient the color in the collect line was too light.The operator did a blood prime but noticed the saline was left open.This was a 1 liter bag and there was approximately 600 mls left in the bag.The operator reported that about 55 minutes into the run and it was still establishing initial interface.Per the customer, the cp was lowered from 50 to 28 and the color in the collect port was still pink.The alarms that were reported during the run were interface took too long to establish and there was no troubleshooting done.Terumo bct support had the operator lower the original patient hct from 21 down to 18.Support had the customer wait about 5 min.During this time the customer had the alarm again.After 5 min there was no change in the interface and the color.Terumo bct support had the operator lower the patient hct down to 15.Per follow up from the customer they ended the procedure early because the patient spiked a temperature of 100.4.They processed 2.8 liters out of the original order of 3 liters.The patient tbv is 1200 mls.There was no rinse back and the final fb was 112%.Prior to the procedure the patient had radiation therapy with some type of anesthesia.The customer reported that the patient received an unknown antibiotic, blood cultures of rij shiley apheresis catheter & portacath.The blood cultures from the portacath and rij cath were negative.Hct was performed about 6hrs post procedure in anticipation of pre procedure planned transfusion the patient was reported as stable, afreible.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 h.6 and h.10.Corrected information is provided in b.3.Investigation: per follow up with the customer the patient received a planned transfusion approx.8 to 10 hrs post collection (in preparation for a surgical procedure).The transfusion was not a direct result of the diluted custom prime.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that during a continuous mononuclear cell (cmnc) collection on a pediatric patient the color in the collect line was too light.The operator did a blood prime but noticed the saline was left open.This was a 1 liter bag and there was approximately 600 mls left in the bag.The operator reported that about 55 minutes into the run and it was still establishing initial interface.Per the customer, the cp was lowered from 50 to 28 and the color in the collect port was still pink.The alarms that were reported during the run were interface took too long to establish and there was no troubleshooting done.Terumo bct support had the operator lower the original patient hct from 21 down to 18.Support had the customer wait about 5 min.During this time the customer had the alarm again.After 5 min there was no change in the interface and the color.Terumo bct support had the operator lower the patient hct down to 15.Per follow up from the customer they ended the procedure early because the patient spiked a temperature of 100.4.They processed 2.8 liters out of the original order of 3 liters.The patient tbv is 1200 mls.There was no rinse back and the final fb was 112%.Prior to the procedure the patient had radiation therapy with some type of anesthesia.The customer reported that the patient received an unknown antibiotic, blood cultures of rij shiley apheresis catheter & portacath.The blood cultures from the portacath and rij cath were negative.Hct was performed about 6hrs post procedure in anticipation of pre procedure planned transfusion the patient was reported as stable, afreible.The collection set is not available for return because it was discarded by the customer.

Manufacturer Narrative

Investigation: per follow up with the customer the patient received a planned transfusion approx.8 to 10 hrs post collection (in preparation for a surgical procedure).The transfusion was not a direct result of the diluted custom prime.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.The run data file (rdf) was analyzed for this event.Review of the dlog and aim images confirmed the interface was not able to be established at the beginning of the collection likely due to the inlet saline roller clamp remaining open as reported by the customer.The operator received the ¿interface took too long to establish¿ alarm about 47 minutes into the procedure, and again at 60 minutes.This alarm can occur for several reasons which include leaving the inlet saline roller clamp open as this dilutes the incoming blood into the centrifuge.The operator reported closing the inlet saline roller clamp roughly 55 minutes into the procedure.At 60 minutes into the run, shortly after the second interface alarm, the operator correctly lowered the patient hct a second time.Signals confirmed the interface was able to be established and the run proceeded.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that during a continuous mononuclear cell (cmnc) collection on a pediatric patient the color in the collect line was too light.The operator did a blood prime but noticed the saline was left open.This was a 1 liter bag and there was approximately 600 mls left in the bag.The operator reported that about 55 minutes into the run and it was still establishing initial interface.Per the customer, the cp was lowered from 50 to 28 and the color in the collect port was still pink.The alarms that were reported during the run were interface took too long to establish and there was no troubleshooting done.Terumo bct support had the operator lower the original patient hct from 21 down to 18.Support had the customer wait about 5 min.During this time the customer had the alarm again.After 5 min there was no change in the interface and the color.Terumo bct support had the operator lower the patient hct down to 15.Per follow up from the customer they ended the procedure early because the patient spiked a temperature of 100.4.They processed 2.8 liters out of the original order of 3 liters.The patient tbv is 1200 mls.There was no rinse back and the final fb was 112%.Prior to the procedure the patient had radiation therapy with some type of anesthesia.The customer reported that the patient received an unknown antibiotic, blood cultures of rij shiley apheresis catheter & portacath.The blood cultures from the portacath and rij cath were negative.Hct was performed about 6hrs post procedure in anticipation of pre procedure planned transfusion the patient was reported as stable, afreible.The collection set is not available for return because it was discarded by the customer.

Manufacturer Narrative

Investigation: per follow up with the customer the patient received a planned transfusion approx.8 to 10 hrs post collection (in preparation for a surgical procedure).The transfusion was not a direct result of the diluted custom prime.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.The run data file (rdf) was analyzed for this event.Review of the dlog and aim images confirmed the interface was not able to be established at the beginning of the collection likely due to the inlet saline roller clamp remaining open as reported by the customer.The operator received the ¿interface took too long to establish¿ alarm about 47 minutes into the procedure, and again at 60 minutes.This alarm can occur for several reasons which include leaving the inlet saline roller clamp open as this dilutes the incoming blood into the centrifuge.The operator reported closing the inlet saline roller clamp roughly 55 minutes into the procedure.At 60 minutes into the run, shortly after the second interface alarm, the operator correctly lowered the patient hct a second time.Signals confirmed the interface was able to be established and the run proceeded.A disposable complaint history search was performed for this lot and found no reports for similar issues on this lot.According to the aabb circular of information for the use of human blood components (revised 2017).Febrile nonhemolytic reactions are typically manifested by a temperature elevation of >1c or 2f occurring during or within 4 hours after a transfusion and in the absence of any other pyrexic stimulus or active warming.Febrile reactions may occur in less than 1% of transfusion of leukocyte-reduced red cell components and about 5% of leukocyte-reduced apheresis platelet components.Febrile reactions occur more frequently in patients receiving non-leukocyte-reduced components and those previously alloimunized by transfusion or pregnancy.Antipyretics usually provide effective symptomatic relief.Patients who experience repeated, severe febrile reactions may benefit from receiving leukocyte-reduced components.If these reactions are caused by cytokines in the component, prestorage leukocyte reduction may be beneficial.Correction: the customer performed an internal review of the procedure with the staff.She accepted a refresher training and new operator training for new staff for cmnc with an emphasis on low tbv patients.Root cause: a root cause assessment was performed for the decrease in the patient's hematocrit.The root cause was determined to be an operator error where the inlet saline roller clamp was inadvertently left open during custom blood prime resulting insufficient blood in the circuit, which required additional volume of rbcs to be removed from the patient after patient connect.A root cause assessment was performed for the patient's adverse reaction.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's catheter was contaminated.* the custom prime rbc was contaminated.* patient's underlying disease state.* patient's reactions to the custom prime rbc unit.

Event Description

The customer reported that during a continuous mononuclear cell (cmnc) collection on a pediatric patient the color in the collect line was too light.The operator did a blood prime but noticed the saline was left open.This was a 1 liter bag and there was approximately 600 mls left in the bag.The operator reported that about 55 minutes into the run and it was still establishing initial interface.Per the customer, the cp was lowered from 50 to 28 and the color in the collect port was still pink.The alarms that were reported during the run were interface took too long to establish and there was no troubleshooting done.Terumo bct support had the operator lower the original patient hct from 21 down to 18.Support had the customer wait about 5 min.During this time the customer had the alarm again.After 5 min there was no change in the interface and the color.Terumo bct support had the operator lower the patient hct down to 15.Per follow up from the customer they ended the procedure early because the patient spiked a temperature of 100.4.They processed 2.8 liters out of the original order of 3 liters.The patient tbv is 1200 mls.There was no rinse back and the final fb was 112%.Prior to the procedure the patient had radiation therapy with some type of anesthesia.The customer reported that the patient received an unknown antibiotic, blood cultures of rij shiley apheresis catheter & portacath.The blood cultures from the portacath and rij cath were negative.Hct was performed about 6hrs post procedure in anticipation of pre procedure planned transfusion the patient was reported as stable, afreible.The collection 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: 12855891
• MDR Text Key: 285919593
• Report Number: 1722028-2021-00360
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583123205
• UDI-Public: 05020583123205
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK150251
• 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,Followup,Followup,Followup
• Report Date: 11/19/2021

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 Expiration Date: 08/01/2023
• Device Model Number: 12320
• Device Catalogue Number: 12320
• Device Lot Number: 2108043230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/27/2021
• Initial Date FDA Received: 11/22/2021
• Supplement Dates Manufacturer Received: 01/05/2022; 01/13/2022; 06/22/2022; 07/01/2022
• Supplement Dates FDA Received: 01/07/2022; 02/01/2022; 06/27/2022; 07/12/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/09/2021
• 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
• Patient Age: 3 YR
• Patient Sex: Female
• Patient Weight: 16 KG