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

Model Number 12320

Device Problems Fluid/Blood Leak (1250); Use of Device Problem (1670)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/14/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation: the customer returned one used optia idl set for investigation.Visual inspection confirmed the set was assembled correctly with no kinks, leaks, occlusions or missing parts.Both saline and ac drip chambers were observed to contain fluid.Flow of prime fluid was observed throughout the inlet coil, channel lines and reservoir.No disposable defects were identified.The collect bag did not contain fluid and there was no fluid in the line to collect bag post y connector.There was fluid in the collect line between cassette and y.The collect line slide clamp between the collect bag and y connector was closed.The slide clamp on the accessory line was closed.The slide clamp on the collect line between the cassette and y connector was open.The presence of fluid was identified in the plasma bag at a volume of approximately 100ml and vent bag at approximately 20ml.The fluid was tested in the qc chemistry lab, using the oxidizable substances limit test to confirm the presence of dextrose (indicating the fluid contained acd-a).The test confirmed the presence of acd-a in the plasma and vent bags.Samples of solution from each bag were tested using a chloride meter.The plasma and vent bags both gave a reading of 109mmol/l cl- (note: 154mmol/l cl- is equivalent to 0.9% saline).Therefore, the fluid in the bags was determined to be a mixture of approximately 70% saline and 30% acd-a.Terumo bct clinical support performed a mock prime using a new disposable set and added fluid to the collect bag in the cs equipment lab.The collect valve closes during pressure testing and stays closed for the entire priming sequence.If this valve were to be open the machine would give a valve position error alarm preventing prime from continuing.This shows that it would not be possible for fluid added to the collect bag to flow through the set and back to the patient.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that during and after priming of the disposable set on an optia device they attempted to add anticoagulant (ac) to the collect bag, but the ac kept draining out of the bag into the disposable set.Per the customer, they attempted to add 40 mls of anticoagulant (20mls two times) to the collect bag via the additive line on the collect bag during prime but the fluid came out of the bag and into the set.The customer tried to repeat this after prime was complete and the same thing happened.Per the customer this set was not used as they did not want to lose a product once the collection started.Upon follow up with the customer, it was reported that a new set was used where the anticoagulant was able to be added to the bag with no further issues.Patient information is unknown at this time.

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h.10.Investigation: the run data file (rdf) was analyzed for this event.Signals in the rdf indicate that the set passed the pressure tests during the loading sequence and all valves were operating as designed.Prime was performed and the device operated as intended.The collect valve and the rbc valve were both in the correct positions during prime, they were both closed.If the fluid was added to the collect bag, the closed valves would have prevented it from entering the set.The device operated as intended.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

There was not a patient connected at the time of the event, therefore no patient information is reasonably known.

Manufacturer Narrative

Investigation is in process.A follow up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information in h.10.Investigation: during the priming sequence, the three (3) valves, rbc, plasma and collect, should all be in the closed position occluding the colle ct-crossover line, plasma line, and collect lines, respectively.If any of these three valves were open during prime, the spectra optia would give a valve position error alarm preventing prime from continuing.Simulation runs were conducted in lakewood and the failure modes were successfully replicated.This event can only happen if the collect bag tubing was not loaded in the collect valve or the collect crossover tubing was not loaded in the rbc valve.Either of these events could allow acda to drain from the collect line into the reservoir without generating a valve position error alarm.Analysis of the software confirmed that if the first 20 ml of the acda bolus was added during the prime sequence and was able to drain into the reservoir, the return pump would pump it out of the reservoir towards the saline bag via the return line until the system saw air at the lower level sensor (lls2).This first 20 ml bolus would be mixed with 10 ml of saline already in the reservoir plus whatever saline is continuing to come from the centrifuge and pumped into the return line.The 27 ml of saline in the return line between the lls2 and the 2-way return manifold would have 20 ml of acda mixed in.If after prime completed, another 20 ml bolus of acda was added to the reservoir this would basically result in a 2:1 ratio of acda:saline in the return reservoir.This is where the suspect procedure was stopped by the operator.This also explains why the system did not generate level sensor alarms during this stage of the procedure.Per interal risk assessment for this event, it was determined that if the additional acda added to the collect bag as part of a cmnc collection procedure and in the unlikely event were to leak into the set and end up in the saline bag, and the contents administered to the patient as a return line saline bolus, the worst-case health risk, would be "moderate".Investigation is in process.A follow up report will be provided.

Manufacturer Narrative

Root cause: based on the dlog analysis, the results from qc chemistry tests and the simulation runs, this failure can only happen if the collect bag tubing was not loaded in the collect valve or the collect crossover tubing was not loaded in the rbc valve.

Manufacturer Narrative

This report is being filed to provide additional information in h.10.Correction: the customer declined to respond to the retraining request offered by terumo bct clinical support.Investigation is in process.A follow up report will be provided.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA IDL SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 9427239
• MDR Text Key: 187627061
• Report Number: 1722028-2019-00400
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583123205
• UDI-Public: 05020583123205
• Combination Product (y/n): N
• PMA/PMN Number: K183081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2021
• Device Model Number: 12320
• Device Catalogue Number: 12320
• Device Lot Number: 1909203230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2019
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 02/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other