MAUDE Adverse Event Report: THERAKOS CELLEX PHOTOPHERESIS SYSTEM

Model Number NOT APPLICABLE

Device Problem Use of Device Problem (1670)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 05/13/2019

Event Type  Injury  

Manufacturer Narrative

The system was used for treatment.This case is reportable as a mdr due to the medical intervention of the blood transfusion that was provided to the patient.Since this event is associated with the treatment, this mdr will be against the instrument.No service was requested by the customer for this adverse event.A device service history review was performed.The instrument has been located at the customer's site since 09-nov-2016.As part of the review, it was determined that the instrument's last service prior to the event was on 12-dec-2018.During this service the system checkout procedure was successfully completed indicating that the instrument had passed all tests, met all specifications, and was operational.The investigation for this complaint was performed based on the customer's complaint description and the returned cellex kit with smart card.The returned kit was visually examined and no obvious manufacturing issues were identified.There were no visible kinked or misrouted tubing within the kit.Testing of the kit did not find any issue with the kit that would could have interfered with the return of blood from the return bag.A batch record review for kit lot h204 was performed.There were no non-conformances associated with this lot.This lot met all release requirements.The smart card data was reviewed and prime was completed without incident.The blood prime procedure had been successfully completed, and the system was configured to double needle mode.The instrument's fluid balance reading was set to zero.Three alarm #17: return pressure alarms occurred due to pressure above the upper limit.The customer made a pump rate change in response to these alarms and proceeded with the treatment.Shortly after, three alarm #16 collect pressure alarms occurred and the customer was able to resolve these alarms.The treatment continued for an additional twenty (20) minutes until an alarm #19: fluid balance limit alarm occurred due to a negative patient fluid balance (i.E., -501ml) beyond the instrument's preset limits of +/- 500ml.The customer then aborted the treatment.An attempt to recreate the incident was performed in order to recreate the data observed in the customer's smart card.The alarm #17: return pressure alarms that were captured on the customer's smart card were reproduced by leaving the return line clamp closed after changing from single needle mode to double needle mode and continuing to perform the treatment.A pump rate change was initiated at the time of the alarm #17: return pressure alarms, as experienced by the customer, and the return pump rate was set to 0ml/min.The return pressure alarms were resolved once the return clamp was opened.The alarm #16: collect pressure alarms occurred, as recorded in the customer's smart card data, when the clamp on the collect line was left closed upon restarting the treatment.Once the collect clamp was opened, the collect alarms were resolved and the treatment continued.With the return pump rate set at 0ml/min, all of the fluid volume data recorded on the test smart card matched the data in the customer's smart card.In addition, the test instrument also generated a fluid balance alarm with approximately the same amount of fluid volume remaining in the return bag.The investigation determined that the most likely root cause for this incident was use error.The user likely reduced the return pump rate to zero during the pump rate change in response to the alarm #17: return pressure alarms and never increased the return pump rate above zero during the treatment procedure.As a result, the cellex instrument collected blood from the patient at a rate of 25 ml/minute for 20 minutes (i.E., 25 ml/minute x 20 minutes = 500ml blood collected from patient) without returning any processed blood to the patient.This conclusion was supported by the fact that the instrument initiated a return of kvo (keep vein open) at 10ml/hour.A kvo can only occur if the instrument's return rate is set at 0ml/min.The fact that the instrument could perform the kvo also further indicates there was no issue with the instrument's return pump.In addition, there were no manufacturing issues identified with the returned kit, and there were no pump error alarms captured by the smart card.Furthermore, the instrument was used the following day on an adult patient without any issue.The cellex instrument's pump rates, return/collect pressure, and fluid balance limits are constantly monitored on the instrument's main display.The user can continually monitor these values throughout a patient's ecp treatment.In addition, the return and treatment bags are attached to the exterior of the instrument and the fluid volume in each bag is visible to the user throughout the patient's treatment.Therefore, the accumulation of over 500ml of patient blood would have been visible to the cellex user.A company clinical specialist has subsequently observed two additional ecp treatments at the customer's site in order to ensure the proper execution of the blood prime procedure and no further issues have occurred.No further actions are required at this time.This investigation is now considered complete.Trends were reviewed for complaint categories, alarm #19: fluid balance limit and hypotension.No trends were detected for these complaint categories.The assessment is based on information available at the time of the investigation.Complaints are monitored through tracking and trending.If a trend is detected, further investigation will be conducted.Adverse event terms: hypotension.(b)(4).

Event Description

The customer reported that an extracorporeal photopheresis (ecp) patient experienced hypotension during a treatment procedure.The customer stated that an alarm #19: fluid balance limit alarm occurred during a blood prime ecp treatment procedure as the patient's fluid balance limit had reached -500ml.The customer reported that they had already stopped the treatment.The customer stated that the patient had experienced hypotension but apart from that, the patient was stable.The customer reported that the patient's treating physician had decided to end the treatment and to very slowly return the blood back to the patient by the instrument in order to replace the patient's extracorporeal volume but to also avoid overfilling.The customer was instructed to increase the instrument's fluid balance limit setting by 50ml in order to reset the alarm, so that the instrument would start to return the blood back to the patient.However, the customer reported that another doctor in their department had decided not to return the blood to the patient by the instrument, but instead ordered a transfusion of packed red blood cells for the patient.The customer stated that the patient's next ecp treatment procedure was planned within the next two days.The customer reported that both she and the patient's treating physician (who was present till they started collecting from the patient), believed that all of the steps for the patient's ecp blood prime treatment procedure had been correctly performed.The patient's treating physician stated that the patient's blood pressure had been both automatically and constantly measured throughout the patient's ecp treatment procedure.The physician reported that the patient's blood pressure was 160/100mmhg prior to the event and then went rapidly down to 60/40mmhg during the incident.The physician stated that the patient's blood pressure then went up again to 110/70mmhg shortly after stopping the patient's ecp treatment procedure and providing the patient with volume.The physician reported that the patient's blood pressure has remained stable from that point on and that the patient continues to do well.The physician stated that the patient had been intubated since(b)(6) 2019 a week before their ecp treatment procedure due to severe pain and lack of sufficient reflexes as a result of their underlying condition.The physician reported that the patient could be extubated on (b)(6) 2019 as his vital signs have been good and both his hemoglobin and hematocrit levels have been stable at all times.The physician stated that they would review the case in the coming days.The physician reported that the instrument had been used the following day on an adult patient without any issues.The physician stated that they planned on treating the patient with another ecp treatment procedure on (b)(6) 2019.The physician reported that the patient's condition has improved since starting their ecp treatment procedures in regards mostly to his skin.The physician stated that the patient's pre-ecp skin lesions and defects now seem to have almost completely healed.The customer reported that the patient's next ecp blood prime treatment procedure was postponed until (b)(6) 2019 due to trained operators not being available.The customer stated that this treatment went well.A company clinical specialist was on site for the patient's following ecp blood prime treatment procedure on (b)(6) 2019.The clinical specialist reported that this treatment was successfully completed and the patient remained isovolemic during the treatment.The clinical specialist stated that the patient was in stable condition at the end of the treatment.The customer reported that the instrument that was used for the patient's last two successfully completed ecp blood prime treatments was not the instrument that the patient was on at the time of the event.The customer stated that this instrument was in a different building and the customer did not want to change instruments again without urgent need.The kit and smart card will be returned for investigation.

Manufacturer Narrative

A follow-up with the customer concerning this case was performed on (b)(6) 2019 which provided additional information regarding this complaint.The following field within this medwatch contains additional information: b5.(b)(4).(b)(6) 2019.

Event Description

A follow-up with the customer concerning this case was performed on (b)(6) 2019, and the customer stated that the patient was doing very well and had been discharged from the hospital at the end of the week of (b)(6) 2019.The customer reported that in the two weeks after the last visit by the company clinical specialist, the patient had two additional ecp treatments procedures per week and all went fine.The customer stated that from now on, the patient would receive two ecp treatment procedures bi-weekly.The customer reported that the patient would be admitted to the hospital the day before his ecp treatment procedure, in order to ensure timely ordering of cross-matched packed red blood cells and to also check the patient's broviac catheter.The customer stated that if necessary, overnight thrombolytic therapy (alteplase) would be performed in order to optimize the patient's access.The customer reported that they will perform the patient's bi-weekly ecp treatment schedule for another five to six weeks and then they will switch to a monthly schedule.The customer stated that both trained nurses, together with the physician supervising, would perform all of the patient's ecp treatment procedures.The customer reported that both the adverse event and future ecp treatment procedures were discussed with the operator concerned.

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS; bedminster NJ
• MDR Report Key: 8694200
• MDR Text Key: 147862378
• Report Number: 2523595-2019-00067
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 10705030100009
• UDI-Public: (01)10705030100009(11)160630
• Combination Product (y/n): N
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 07/11/2019

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 Model Number: NOT APPLICABLE
• Device Catalogue Number: CELLEX
• Device Lot Number: NOT APPLICABLE
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/13/2019
• Initial Date FDA Received: 06/12/2019
• Supplement Dates Manufacturer Received: 06/12/2019
• Supplement Dates FDA Received: 07/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Congenital Anomaly; Required Intervention
• Patient Age: 6 YR
• Patient Weight: 22