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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO BCT SPECTRA OPTIA; SPECTRA OPTIA EXCHANGE SET
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TERUMO BCT SPECTRA OPTIA; SPECTRA OPTIA EXCHANGE SET Back to Search Results
Catalog Number 10220
Device Problems Excess Flow or Over-Infusion (1311); Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/24/2019
Event Type  malfunction  
Manufacturer Narrative
Investigation is in process.A follow-up report will be provided.
 
Event Description
The customer reported while performing priming on spectra optia , they received 'high-level reservoir sensor failed fluid check' alarm and 'high level reservoir sensor detected excess fluid 'alarm.The customer contacted terumo bct for troubleshooting.The customer stated that at the beginning of the run, an 'adjusting volume in reservoir' message occurred and the machine was turned off with the saline roller clamp open.Per the customer, the patient was attached and they noticed that the saline roller clamp was left open inadvertently and observed that saline was gone into the waste bag.The volume in the reservoir was elevated and started to come down as it went into exchanging the replacement.The clinical support specialist explained to the operator that the plasma valve would have been in the open state at the end of prime and if the saline roller clamps were also left open, the saline would have been moved into the waste bag.The customer further clarified that they did not turn the machine off.The machine was left on and the roller clamps were left open while they waited for the patient to arrive.As per the last reported status from the customer, the procedure on patient was continued and going 'well' without any issues.The information for the investigation such as procedural details, patient information and outcome is not available at this time.The exchange 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: saline entered the set and 40 ml was subsequently prime diverted up into the waste bag.Upon patient connect as the blood is coming in, the plasma valve would move to the close position to prevent blood from spilling into the plasma line.As more blood is coming in, the saline in the set will be returned to the patient until enough blood enters the channel to establish the interface.Investigation is in process.A follow-up report will be provided.
 
Manufacturer Narrative
Investigation: per the customer, the normal saline bags used were 500mls.The procedural cautions section of the spectra optia apheresis system essentials guide states that if the roller clamp on the saline line is left completely open when the patient is connected, the patient will be quickly infused with a large volume of saline.The run data file (rdf) was analyzed for this event.The signals do show there was more fluid in the reservoir than expected right when the procedure started.The operator hit start run and then immediately received the high level alarm from the reservoir sensors.This could be due to the saline clamps being misaligned during prime which would also have caused the "high-level reservoir sensor failed fluid check" alarm.The signal was stable and level was steady once the procedure was started and they already confirmed that the saline roller clamp was open when it should not have been.The reservoir signals do show the procedure started with more fluid than the device expected.The pumps operated properly as did the valves.This machine operated as intended.Patient tbv: 3901 ac to the patient: 35ml saline to patient: 154ml rinseback was completed customer uses a 500ml saline bag tbv = 3901 ml fb = 100% ecv = 197 ml fb = (500-197 ml) + 3901 x 100 = 4204 = 107.8% final fb (estimated) correction: the customer was aware of the error and clinical support had discussed the error with the customer at the time of the call.Multiple attempts to contact the customer resulted in no response, no further training could be conducted specific to this incident.Root cause: based on the clinical findings and the run data file analysis, the root cause was determined to be due to the operator's failure to follow the screen prompt to close the inlet saline roller clamp at the end of prime divert.
 
Event Description
After multiple attempts the patient's id, age and outcome were not available from the customer.The procedure was continued after troubleshooting and there was no injury reported regarding this incident.Patient¿s gender and weight were obtained from the run data file (rdf).
 
Manufacturer Narrative
This report is being filed to provide in investigation:a review of the device history record (dhr) for this unit showed no irregularitiesduring manufacturing that were relevant to this issue.Investigation is in process.A follow-up report will be provided.
 
Manufacturer Narrative
This report is being filed to provide updated information in g.1 and g.2.Investigation is in process, a follow-up report will be provided.
 
Manufacturer Narrative
This report is being filed to provide investigation: for alarm 'high level reservoir sensor failed fluid check', the sensor did notdetect fluid when expected for this event.It instructs to confirm that both saline lines are openand to remove any obstructions.The optia machine does not detect fluid at the upper reservoirlevel sensor after 74ml of fluid has been pumped by the inlet pump.It will empty the reservoirand retry.Investigation is in process.A follow-up report will be provided.
 
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Brand Name
SPECTRA OPTIA
Type of Device
SPECTRA OPTIA EXCHANGE SET
Manufacturer (Section D)
TERUMO BCT
lakewood CO 80215
MDR Report Key8807278
MDR Text Key165012944
Report Number1722028-2019-00189
Device Sequence Number1
Product Code LKN
Combination Product (y/n)N
PMA/PMN Number
K183081
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 07/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/01/2021
Device Catalogue Number10220
Device Lot Number1905143330
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Initial Date Manufacturer Received 06/24/2019
Initial Date FDA Received07/19/2019
Supplement Dates Manufacturer Received08/02/2019
09/25/2019
11/05/2019
12/04/2019
12/13/2019
Supplement Dates FDA Received08/13/2019
09/26/2019
11/12/2019
12/06/2019
12/26/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Weight64
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