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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: THERAKOS CELLEX PHOTOPHERESIS SYSTEM
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THERAKOS CELLEX PHOTOPHERESIS SYSTEM Back to Search Results
Model Number CELLEXUSA
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problems Bradycardia (1751); Low Blood Pressure/ Hypotension (1914); Hypovolemic Shock (1917); Low Oxygen Saturation (2477); Syncope/Fainting (4411)
Event Date 11/15/2020
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 oxygen that was provided to the patient.Since this event is associated with the treatment, this mdr will be against the instrument.The instrument has been located at the customer's site since (b)(6) 2019.The customer has their own biomed who performs all of the service on this instrument.No product was returned for investigation.The root cause for this case is use error as the customer acknowledged that the instrument's collect rate (50 ml/min) was higher than the return rate (40 ml/min) during the patient's ecp treatment.In section 10-20 entitled collect: (drawing/returning from/to patient in dn mode) in the cellex operator's manual it states, "to keep the patient isovolemic, set the collect flow rate equal to the return flow rate.Periodically it may be necessary to adjust rate independently." in response to the incident, the customer increased the instrument's return rate from 40 ml/min to 60 ml/min.The patient fully recovered once their blood was returned by the instrument and after receiving oxygen.The distributor will be providing the customer with refresher training.Trends were reviewed for complaint categories hypovolemic shock, oxygen desaturation, hypotension, bradycardia, and fainted.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: hypovolemic shock, low oxygen saturation, low blood pressure/ hypotension, bradycardia, and syncope/fainting.(b)(4).
 
Event Description
The distributor reported that an extracorporeal photopheresis (ecp) patient experienced hypovolemic shock, oxygen desaturation, hypotension, bradycardia, and fainted during an ecp treatment procedure on (b)(6) 2020.The distributor stated that the patient was being treated for lung graft versus host disease and always has breathing problems.The distributor reported that the patient used to be tired before her ecp treatment procedures.The distributor stated that the patient's ecp treatment procedure was in double needle mode (dnm) with a collect rate of 50ml/min, and a return rate of 40ml/min.The distributor reported that the patient had normal blood pressure and oxygen saturation levels prior to their ecp treatment procedure and up until the buffy coat extraction phase of their ecp treatment procedure.The distributor reported that during the buffy coat extraction phase, the patient experienced hypovolemic shock.The distributor stated that the patient's oxygen saturation dropped to 80%, and the patient fainted.The distributor reported that the patient also experienced hypotension, and bradycardia with a heart rate of 45.The distributor stated that the patient's fluid balance was more negative than could be expected and the volume in the return bag was very high.The distributor reported that oxygen was administered to the patient and the patient's oxygen saturation increased to 90%.The distributor stated that the instrument's return rate was also increased from 40ml/min to 60ml/min.The distributor reported that after the oxygen was administered to the patient and the blood within the instrument was returned back to the patient, the patient fully recovered.The distributor stated that all of the patient's vitals taken post incident were back to normal.The distributor reported that the patient was not hospitalized longer than planned.The distributor reported that he attended the patient's next ecp treatment procedure the following day on (b)(6) 2020.The distributor stated that the patient's ecp treatment procedure on (b)(6) 2020 went smoothly and this ecp treatment procedure was successfully completed with the patient's vitals remaining stable throughout the treatment procedure.The distributor reported that all the of the patient's previous ecp treatments procedures were also successfully completed.The distributor stated that the patient was currently in stable condition.The distributor stated that there was a direct cause between the patient's ecp treatment procedure and the reported incident.A therakos clinical specialist spoke with the distributor and referred the distributor to the cellex operator's manual.The therakos clinical specialist explained to the distributor that when an ecp treatment procedure is in dnm, the return rate should never be lower than the collect rate in order to avoid the blood remaining in the return bag and to avoid the patient's fluid balance from going progressively negative.The distributor reported that they would be providing this customer with refresher training.No product was returned for investigation.
 
Manufacturer Narrative
The smart card was returned for investigation.The smart card data was reviewed.Prime was successfully completed and the instrument's fluid balance limits were set to +/- 549 ml.Collection began in double needle mode.The collect and return rate limits were changed to 50 ml/min for the collect flow rate and 35 ml/min for the return flow rate eleven minutes after the treatment started.Four alarm #16: collect pressure alarms then occurred and were resolved by the customer.The operator reduced the instrument's bowl optic sensor threshold to 140, then to 130, and finally to 100 after 950ml of whole blood processed.The buffy coat collection phase began after 1425ml of whole blood processed.The customer pressed the stop button after 78ml of buffy volume had been collected.An alarm #17: return pressure alarm for pressure above the upper limit then occurred and the operator pressed the start button to resume the treatment.Two alarm #17: return pressure alarms for pressure above the upper limit occurred and were resolved by the customer.The buffy coat collection phase began again after 1622ml of whole blood processed.Four alarm #16: collect pressure alarms occurred and were resolved by the customer.An alarm #10: buffy volume exceeded alarm occurred after 181ml of buffy volume had been collected.The customer raised the instrument's upper fluid balance limit to +675ml.A second alarm #10: buffy volume exceeded alarm occurred after 206ml of buffy volume had been collected and the operator pressed the end buffy button.Photoactivaton took place and the treatment ended automatically, as expected.The end treatment record is the last recorded event on the smart card.The smart card data confirmed the root cause of use error for this case as the collect rate was greater than the return rate during the majority of the buffy coat collection.The patient's fluid balance fell steadily reaching a value of -396 ml when the buffy coat collection phase first began.The return flow rate was then increased to 60 ml/min after the occurrence of the alarm #17: return pressure alarms and the patient's fluid balance rose in value to -109 ml when the buffy coat collection was finished.The patient's fluid balance was +407 ml when the treatment was completed.Correction: the smart card confirmed that the return flow rate was 35 ml/min and not 40 ml/min as previously mentioned by the customer.(b)(4) 01/14/2020.
 
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Brand Name
CELLEX PHOTOPHERESIS SYSTEM
Type of Device
CELLEX PHOTOPHERESIS SYSTEM
Manufacturer (Section D)
THERAKOS
bedminster NJ
MDR Report Key11052697
MDR Text Key223724300
Report Number2523595-2020-00135
Device Sequence Number1
Product Code LNR
UDI-Device Identifier10705030100009
UDI-Public(01)10705030100009(11)180416
Combination Product (y/n)N
PMA/PMN Number
P860003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Type of Report Initial,Followup
Report Date 01/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberCELLEXUSA
Device Catalogue NumberCELLEX
Was Device Available for Evaluation? No
Date Manufacturer Received12/31/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age59 YR
Patient Weight66
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