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

Catalog Number	12120
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/25/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation: per the customer, other alarms that were noted during the run were 'return saline line not closed' alarm and 'interface took too long to establish' alarm.Total amount of fluids machine gave and displayed: acda 1241 mlacda to patient 1211 ml total amount of fluids machine delivered: iv calcium infusion 180 mliv nacl 0.9% 250 mliv nacl 0.9% 500mltotal fluids removed/collected (displayed): 260 mltotal fluids removed/collected (measured): 257 mlan optia collect disposable set containing blood product was received by terumo bct for evaluation.The acor saline bags were not received.Initial observations noted that the sample bag, ac and saline drip chambers and collect bag had all been rf sealed and removed prior to return.Visual examination of the disposable confirmed that the inlet and return saline roller clamps were assembled on the correct lines and in the closed position.The inlet (red) and return (blue) pinch clamps had also been placed in the closed position.The presence of air bubbles could be observed within the aps and inlet trap.There were no manufacturing defects observed on the centrifuge loop and all witness marks indicated that the loop had been correctly loaded.The disposable was visually examined for any kinks, missing parts or other mis assembly and none were found.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.According to the spectra optia apheresis system essentials guide procedural cautions, if the roller clamp on the saline line is left completely open when the subject is connected, the subject will be quickly infused with a large volume of saline.Root cause: based on the customer's description and the analysis of the run data file, the root cause was attributed to the operator's failure to follow the screen prompt to close the inlet saline roller clamp at the end of prime divert.Review of the dlog does not show a conclusive root cause for the emptying of the saline line bag as described by the customer.Although, the beginning of the procedure, the operator does receive the, ¿return saline line was not closed¿ alarm, but only receives it once and presumably was able to continue after.However, the operator received the ¿interface took too long to establish alarm¿ shortly after and also receives the ¿centrifuge pressure sensor exceeded limit¿ alarm.The ¿interface took too long to establish alarm¿ can occur for several reasons.In this case, it is possible that leaving the inlet saline roller clamp open may explain this alarm.If the saline bag was completely emptied it may also explain why it was noted that there was "air/vacuum" as explained by the customer in the access line.The alarm, ¿centrifuge pressure exceeded limit¿, likely occurred because the inlet saline clamp was open or partially open, leading to the saline bag being empty and possibly drawing air into the channel and leading to the alarm.It is possible that the operator left the inlet saline roller clamp opened and therefore diluted what was entering the machine leading to the interface alarm.It is important for the operator to ensure they follow all the screen prompts for closing and opening pinch clamps and roller clamps when instructed by the system.There are alarms during the disposables tests that alert the operator to possible clamping errors, loading errors, and/or disposable defects as the system is trying to achieve certain pressures in the inlet and return lines.That is why not receiving any of those alarms during the disposables test may indicate a clamping error after the procedure started.Correction: terumo bct has provided feedback to the customer regarding the incident and the customer acknowledged they understood what occured during the procedure.Feed back was provided to the customer regarding the potential of user error in this incident.
Event or Problem Description
The customer reported that approximately 24 minutes into a mono nuclear cell (mnc)collection procedure on an allogenic donor, they received a 'centrifuge pressure exceeded limit' alarm.Upon inspection, the operator noticed air bubbles in the access line.Per customer, the operator paused the procedure and checked the loading of the set.No issues were found and the procedure was continued.The operator stated that bubbles in the access line cleared and they clamped the access line.The red roller clamp was found closed and the access line was found to be working well.The access line was detached and flushed with saline and not clotting was found.While checking the return line operator noticed that the inlet saline roller clamp was not closed and the saline bag was empty.The operator closed the saline roller clamp and replaced the saline bag and continued with the procedure.After collecting the 1st chamber, the operator paused the procedure and disconnected the patient.The inlet access and return lines were then flushed with saline to ensure that there was no air in the saline line.The customer continued the procedure without any further issues.Due to eu personal data protection laws, the donor's identifier and age information are not available from the customer.Donor's gender and weight information were obtained from the run data file (rdf).

• Brand Name: SPECTRA OPTIA
• Common Device Name: SPECTRA OPTIA COLLECT SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 8085724
• Report Number: 1722028-2018-00308
• Device Sequence Number: 13717689
• Product Code: GKT
• UDI-Device Identifier: 05020583121201
• UDI-Public: 05020583121201
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K172590
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/19/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/01/2020
• Device Catalogue Number: 12120
• Device Lot Number: 1806213230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2018
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2018
• Initial Report FDA Received Date: 11/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Weight: 82