MAUDE Adverse Event Report: THERAKOS, INC CELLEX PHOTOPHERESIS SYSTEM

Model Number NOT APPLICABLE

Device Problems Air Leak (1008); Device Displays Incorrect Message (2591)

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

Event Date 09/23/2017

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 and also due to the patient being hospitalized.Since this event is associated with the treatment, this mdr will be against the instrument.Service was requested by the customer.A service technician was at the customer's site on 04-oct-2017 in order to evaluate the instrument.The instrument has been located at the customer's site since 04-jun-2012.Service order report, (b)(4), feedback: the service technician performed a check of the instrument as well as the instrument's periodic maintenance.The service technician replaced the centrifuge spider and the door seal extrusion as part of the instrument's preventive maintenance.The service technician then successfully performed both a water treatment and the system checkout procedure indicating that the instrument had passed all tests, met all specifications, and was fully operational.Trends were reviewed for complaint categories, alarm #53: return line air detected, malaise, cough, shortness of breath, hypotension, other adverse event: cyanosis, and other adverse event: desaturation.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, and dyspnea.(b)(4).

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 21(b)(6) 2017 was reported under 2523595-2017-00189.The customer reported that on (b)(6) 2017, a patient underwent an extracorporeal photopheresis (ecp) treatment using the blood prime procedure.The customer stated that towards the very end of the buffy coat reinfusion phase of the treatment, several alarm #53: return line air detected alarms occurred.The customer reported that the treatment was then paused and they noticed that there was air in both the pump tubing organizer (pto) and the return line.The customer stated that the air was observed in the return line between the kit's filter and the return line air detector.The customer reported that no air was present in the return line after the return line air detector and they confirmed that no air was returned to the patient.The customer stated that the patient began to not 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 desaturation.The customer reported that the treatment was then aborted and the patient was given oxygen.The customer stated that the patient was also hospitalized.The customer reported that as of (b)(6) 2017, the patient's condition was "good" but the patient was still under observation.The patient's blood pressure and o2 values were requested but not provided by the customer.A therakos clinical services specialist arrived at the site on (b)(6) 2017, and obtained additional information regarding this treatment.The customer stated that while the patient was in the hospital, a chest xray and an echocardiography were performed.The customer reported that hemocultures were also performed in order to check for possible infections and all results were negative.The customer stated that no other medical intervention was performed for this patient.The customer reported that the patient was discharged in the end and has already undergone two successful ecp treatments this past week.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 aggregates 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+heparin as the anticoagulant and this treatment was successfully completed with no issues.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: 6957237
• MDR Text Key: 89581553
• Report Number: 2523595-2017-00190
• 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: 01/13/2012
• 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): Hospitalization; Required Intervention
• Patient Age: 5 YR