MAUDE Adverse Event Report: THERAKOS, INC CELLEX PHOTOPHERESIS SYSTEM

Model Number NOT APPLICABLE

Device Problem Device Displays Incorrect Message (2591)

Patient Problems Cyanosis (1798); Dyspnea (1816); High Blood Pressure/ Hypertension (1908); Low Blood Pressure/ Hypotension (1914); Malaise (2359); Low Oxygen Saturation (2477); No Information (3190)

Event Date 09/21/2017

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 given to the patient.Since this event is associated with the treatment, this mdr will be against the instrument.Service was requested by the customer.A service technician arrived at the customer's site on (b)(4) 2017 in order to evaluate the instrument.The instrument has been located at the customer's site since 05-june-2009.Service order report, (b)(4), feedback: the service technician successfully completed the system checkout procedure indicating that the instrument had passed all tests, met all specifications, and was fully operational.No issues were found with the instrument during the evaluation.Trends were reviewed for complaint categories, alarm #53: return line air detected, clots observed, malaise, hypotension, other adverse event: cyanosis, other adverse event: desaturation, cough, shortness of breath, and hypertension.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: malaise, hypotension, cyanosis, oxygen saturation-low, other: cough, dyspnea, and hypertension.

Event Description

The customer called in regards to a patient who experienced hypotension, cyanosis, and desaturation during the buffy coat return phase of the treatment.The customer stated that this patient experienced these same adverse events during two separate treatments on (b)(6) 2017.The customer reported that these adverse events occurred during the same phase of the treatment, the buffy coat return phase, for both of these treatments.The customer reported that they do not use uvadex at their facility and instead use salf 8mop.The customer stated that they were not sure if the patient's adverse events were due to the salf 8mop or the treatment itself.This case is for the treatment that occurred on (b)(6) 2017.The treatment that occurred on (b)(6) 2017 was reported under 2523595-2017-00190.The customer reported that on (b)(6) 2017, a patient underwent an extracorporeal photopheresis (ecp) treatment using a blood prime procedure.The customer stated that towards the very end of the buffy coat return phase of the treatment, the patient began not to feel well.The customer reported that the patient developed a cough and shortness of breath.The customer also stated that the patient became cyanotic and experienced both hypotension and rapid desaturation.The customer reported that the treatment was then aborted and the patient was given oxygen.A therakos clinical services specialist arrived at the site on (b)(6) 2017, and obtained additional information regarding this treatment.The customer reported that this was the patient's third ecp treatment.The customer stated that an alarm #53: return line air detected alarm occurred at the same time that the patient began to feel unwell.The customer reported that no air was returned to the patient.The customer stated that the patient's plasma was lipidemic though an alarm #46: red blood cell pump alarm did not occur during the treatment.The customer reported that during the treatment, the patient's treated buffy coat was only partially returned to the patient due to the onset of the patient's symptoms.The customer stated that the patient's buffy coat looked "strange with the consistency of jelly".The customer also reported that aggregates were visible in both the patient's buffy coat and in the kit's filter.The customer stated that they were not able to follow this treatment as closely as they usually do, as on this day there were other types of departmental emergencies that required their immediate attention.The patient's outcome at the end of the treatment was requested but not provided by the customer, though the patient did undergo another ecp treatment on (b)(6) 2017.The patient's blood pressure and o2 values were also requested but not provided by the customer.The customer stated that they were also looking into other anticoagulant solutions, such as acda or acda+heparin, in order to reduce the likelihood of aggregrates during treatment.The customer reported that during the heparin administration the patient's prothrombin time remained unchanged during the procedure so they suspected something might be very peculiar for this patient in relation to his coagulation abilities.The customer stated that the patient underwent another ecp treatment on (b)(6) 2017 using acda+heprin as the anticoagulant and this treatment was successfully completed with no issues.On (b)(6) 2017, the customer reported that the patient experienced transient hypertension when the patient started to feel unwell during the treatment on (b)(6) 2017.The customer stated that the patient's blood pressure peaked at 155/99mmhg during this time.The customer reported that the patient was also scared at this time due to their breathing difficulties.Service was requested.No product was returned for investigation.

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS, INC; bedminster NJ
• Manufacturer (Section G): THERAKOS, INC.; 10 north high street; suite 300; west chester PA 19380
• Manufacturer Contact: megan vernak ; 1425 us route 206; bedminster, NJ 07921
• MDR Report Key: 6957230
• MDR Text Key: 89572228
• Report Number: 2523595-2017-00189
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/17/2017

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: Nurse
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CELLEX
• Device Lot Number: NOT APPLICABLE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/24/2017
• Initial Date FDA Received: 10/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 5 YR