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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO BCT SPECTRA OPTIA; SPECTRA OPTIA IDL SET
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TERUMO BCT SPECTRA OPTIA; SPECTRA OPTIA IDL SET Back to Search Results
Catalog Number 10313
Device Problems Gas/Air Leak (2946); Adverse Event Without Identified Device or Use Problem (2993); Therapeutic or Diagnostic Output Failure (3023)
Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/11/2022
Event Type  malfunction  
Manufacturer Narrative
Investigation: the customer returned a used optia set for investigation.The presence of blood was noted throughout the set.The set appeared to be assembled correctly with no kinks, occlusions, missing parts or misassemblies.The inlet and return saline line roller clamps were both open upon receipt of the set.The return and inlet lines were found to be heat sealed.The ac and saline lines were flow tested and fluid was able to flow through the kit.Clotting was noted in the inlet and upper pressure sensor, reservoir and return pump header tubing.The channel was found to be full of blood indicating that rinseback had not been performed.Some clotting was also noted in the channel.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 after more than 3 hours of csp collection procedure, they had an alarm concerning the centrifuge.When they restarted, the return line was full of air.They did not complete the return to the patient and there was no reported injury or medical intervention.Patient information is not available at this time.This product is not available within the us, but this report is being filed due to an alleged failure that could occur on a similarly marketed device platform cleared for use by the fda.
 
Event Description
The customer reported that after more than 3 hours of csp collection procedure, they had an alarm concerning the centrifuge.When they restarted, the return line was full of air.They did not complete the return to the patient and there was no reported injury or medical intervention.The patient was examined by the doctor.Due to eu personal data protection laws, the patient information is not available from the customer.This product is not available within the us, but this report is being filed due to an alleged failure that could occur on a similarly marketed device platform cleared for use by the fda.
 
Manufacturer Narrative
Investigation: the customer returned a used optia set for investigation.The presence of blood was noted throughout the set.The set appeared to be assembled correctly with no kinks, occlusions, missing parts or misassemblies.The inlet and return saline line roller clamps were both open upon receipt of the set.The return and inlet lines were found to be heat sealed.The ac and saline lines were flow tested and fluid was able to flow through the kit.Clotting was noted in the inlet and upper pressure sensor, reservoir and return pump header tubing.The channel was found to be full of blood indicating that rinseback had not been performed.Some clotting was also noted in the channel.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.A disposable complaint history search was performed for this lot and found no reports for similar issues on this lot worldwide.The run data file (rdf) was analyzed for this event.Review of the run data files, and aim images suggest that air was introduced through the inlet line into the disposable kit which led to the centrifuge pressure alarms and the issues experienced during this procedure.Analysis confirmed there were several inlet access alarms generated during the procedure prior to the ¿centrifuge pressure exceeded limit¿ alarm generated at 156 minutes into the run.There were two subsequent centrifuge pressure alarms then the operator reset the device at 186 minutes while the system was in centrifuge recovery.Upon boot up, the procedure resumed and continued successfully.At 271 minutes into the run, multiple inlet access alarms occurred (6x) followed by a subsequent centrifuge pressure alarm.At 292 minutes, the operator ended the run and attempted to perform rinseback however another inlet pressure alarm occurred, and the operator unloaded the kit.The ¿centrifuge pressure exceeded limit¿ alarm occurs if the centrifuge pressure is detected at greater than 1350mmhg.This alarm stops the centrifuge when this pressure is reached to prevent damage and/or potential leaks in the centrifuge.This alarm most commonly occurs if the channel was not loaded correctly or if air enters the centrifuge which can happen if the inlet access connection was not secure or loses patency during the procedure.Based on the later timing of the centrifuge pressure alarms, and the corresponding access alarms it is likely that patient access issues contributed to air being pulled into the inlet line which entered the centrifuge generating the centrifuge pressure alarms.Analysis of the dlog and aim images did not detect air in the return line during this procedure as reported in the complaint.The return line air detector (rlad) signals were reviewed and confirmed to be functioning as intended.Investigation is in process.A follow up report will be provided.
 
Manufacturer Narrative
This report is being filed to provide additional information in h.6 and h.10.Investigation: the customer returned a used optia set for investigation.The presence of blood was noted throughout the set.The set appeared to be assembled correctly with no kinks, occlusions, missing parts or misassemblies.The inlet and return saline line roller clamps were both open upon receipt of the set.The return and inlet lines were found to be heat sealed.The ac and saline lines were flow tested and fluid was able to flow through the kit.Clotting was noted in the inlet and upper pressure sensor, reservoir and return pump header tubing.The channel was found to be full of blood indicating that rinseback had not been performed.Some clotting was also noted in the channel.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.A disposable complaint history search was performed for this lot and found no reports for similar issues on this lot worldwide.The run data file (rdf) was analyzed for this event.Review of the run data files, and aim images suggest that air was introduced through the inlet line into the disposable kit which led to the centrifuge pressure alarms and the issues experienced during this procedure.Analysis confirmed there were several inlet access alarms generated during the procedure prior to the ¿centrifuge pressure exceeded limit¿ alarm generated at 156 minutes into the run.There were two subsequent centrifuge pressure alarms then the operator reset the device at 186 minutes while the system was in centrifuge recovery.Upon boot up, the procedure resumed and continued successfully.At 271 minutes into the run, multiple inlet access alarms occurred (6x) followed by a subsequent centrifuge pressure alarm.At 292 minutes, the operator ended the run and attempted to perform rinseback however another inlet pressure alarm occurred, and the operator unloaded the kit.The ¿centrifuge pressure exceeded limit¿ alarm occurs if the centrifuge pressure is detected at greater than 1350mmhg.This alarm stops the centrifuge when this pressure is reached to prevent damage and/or potential leaks in the centrifuge.This alarm most commonly occurs if the channel was not loaded correctly or if air enters the centrifuge which can happen if the inlet access connection was not secure or loses patency during the procedure.Based on the later timing of the centrifuge pressure alarms, and the corresponding access alarms it is likely that patient access issues contributed to air being pulled into the inlet line which entered the centrifuge generating the centrifuge pressure alarms.Analysis of the dlog and aim images did not detect air in the return line during this procedure as reported in the complaint.The return line air detector (rlad) signals were reviewed and confirmed to be functioning as intended.Root cause: 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: * operator failure to tighten luer on return line blood warmer connect and hangs the loose connection high allowing air to be drawn into the line.* disposables defect causes low level sensor to report fluid instead of air resulting in air pumping towards patient.* set defect, clot, or debris occludes return filter resulting in a vacuum between the filter and the return pump header, resulting in degassing the blood.* poor connection to blood warmer due to excess solvent at the luer causes air to enter return line for large patients.* a defective lower level sensor.* obstructed low level sensor due to blood clots resulting in false detection of fluid rather than air leading to air to donor.
 
Event Description
The customer reported that after more than 3 hours of csp collection procedure, they had an alarm concerning the centrifuge.When they restarted, the return line was full of air.They did not complete the return to the patient and there was no reported injury or medical intervention.The patient was examined by the doctor.Due to eu personal data protection laws, the patient information is not available from the customer.This product is not available within the us, but this report is being filed due to an alleged failure that could occur on a similarly marketed device platform cleared for use by the fda.
 
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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 Key14577371
MDR Text Key301634175
Report Number1722028-2022-00177
Device Sequence Number1
Product Code GKT
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 06/02/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/01/2022
Device Catalogue Number10313
Device Lot Number2011193230
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/19/2022
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/11/2022
Initial Date FDA Received06/02/2022
Supplement Dates Manufacturer Received06/03/2022
06/03/2022
Supplement Dates FDA Received06/27/2022
07/18/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/19/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age63 YR
Patient SexFemale
Patient Weight57 KG
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