MAUDE Adverse Event Report: THERAKOS, INC CELLEX PHOTOPHERESIS SYSTEM

Model Number NOT APPLICABLE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Dyspnea (1816); Hypersensitivity/Allergic reaction (1907); Malaise (2359)

Event Date 06/16/2017

Event Type  Injury  

Manufacturer Narrative

The system was used for treatment.This case is reportable as a mdr due to the patient's hospitalization and medical intervention that was given to the patient.Since this event is associated with the treatment, this mdr will be against the instrument.From the device perspective, there was no known device malfunction and no instrument issue was alleged by the customer.No service was requested by the customer for this adverse event.No product was returned therefore, a device service history review was performed.The instrument has been located at the customer's site since 04/30/2013.As part of the review, it was determined that the instrument's last service was on 07/28/2016.During this service the system checkout procedure was successfully completed indicating that the instrument had passed all tests, met all specifications, and was operational.Trends were reviewed for complaint categories, malaise, allergic reaction, shortness of breath.No trends were detected for these complaint categories.The assessment is based on information available at the time of the investigation.No product was returned for investigation; therefore, it could not be determined if the product met specification based solely on the information provided by the customer.Complaints are monitored through tracking and trending.If a trend is detected, further investigation will be conducted.Adverse event terms: malaise, hypersensitivity, and dyspnea.(b)(4).Device not returned to manufacturer.

Event Description

The customer called to report a patient who exhibited the signs of an allergic reaction during a treatment procedure.The customer stated that the patient was being treated for severe mucous membrane pemphigoid.The customer reported that the patient's treatment was successfully completed without any issues.The customer stated that as the patient left the ward and went to his car, the patient started feeling unwell and returned to the ward.The customer reported that patient then developed a severe anaphylactic reaction which included breathing problems.The customer stated that the reaction occurred about 30 to 60 minutes after the completed treatment.The customer reported that the patient was admitted to the icu and was intubated.The customer stated that blood samples were taken in order to determine the patient's tryptase levels, however the results were not provided.The customer reported that the patient's condition had improved but the patient was still hospitalized in the cardiology ward.The customer stated that no further treatments were scheduled due to the patient's reaction.The customer reported that this was the patient's 12th treatment in a schedule of two consecutive treatment days occurring every other week.The customer stated that there had been no patient reaction until the patient's 11th treatment, when the patient experienced a mild reaction of swollen lips and an itching throat during the photoactivation phase of the treatment, prior to the reinfusion of any treated cells (reported under 2523595-2017-00129).The customer reported that then the patient's mild reaction was successfully treated with taligyl and the treatment had been completed.The customer reported that the referring dermatologist informed them that a new medication, valaciclovir, was administered to the patient four days prior to this treatment cycle.The customer stated that this medication was administered to the patient in order to protect the patient from a chickenpox outbreak within the patient's family.The customer reported that they used their own solution of methoxsalen (20 mg/ml) for all their treatment procedures.No product was returned for investigation.

Manufacturer Narrative

In a follow-up with the customer, the customer reported that the patient was administered the medication, t.Tavegyl, prior to his treatment as a preventive measure.In an additional follow-up with the customer on (b)(6) 2017, the customer stated that the patient was no longer hospitalized.The customer did not know the patient's date of discharge as the patient was treated in another ward of the hospital.The customer did not know the patient's current condition or the cause for the patient's allergic reaction.Correction: the name of the medication that was administered to the patient when the patient's symptoms first occurred was miss- spelled in the initial medwatch for this case.The name of the medication is t.Tavegyl and not taligyl as initially reported.(b)(4).

Manufacturer Narrative

In a follow-up with the customer, the customer reported that the patient was initially treated with adrenaline while in the icu.The customer stated that an x-ray of the patient's lungs was performed and it was discovered that the patient had pneumonia with bilateral infiltrates.The customer reported that the patient was discharged from the hospital after a couple of days in approximately the same condition as prior to his adverse event.The customer stated that "our primary belief is not that the patient's reaction was due to a psoralen allergy since this seems to be very rare." please note this facility did not use uvadex, the mallinckrodt/ therakos drug used with the cellex photopheresis system, but instead used their own solution of methoxsalen (20mg/ml) for this patient's treatment.The customer reported that in their opinion "the patient experienced an allergic reaction, and it is difficult to determine exactly against what." the customer stated that the patient had received up to ten ecp treatments prior to this event and never had a reaction before.The customer reported that at the moment of the event, the patient had just been given a new medication (valaciclovir) and they also later discovered that the patient had pneumonia.The patient's lab values before last treatment are as follow: (b)(6).Correction: manufacturer, correction: contact office-name/address.(b)(4).(b)(6).(b)(6) 2017.

• 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; 53 frontage road; bedminster, NJ 07921
• MDR Report Key: 6683563
• MDR Text Key: 78902630
• Report Number: 2523595-2017-00130
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: SW
• 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,Followup,Followup
• Report Date: 07/01/2017

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: 06/22/2017
• Initial Date FDA Received: 07/01/2017
• Supplement Dates Manufacturer Received: 07/07/2017; 08/18/2017
• Supplement Dates FDA Received: 08/04/2017; 08/31/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/21/2013
• 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; Life Threatening; Required Intervention
• Patient Age: 46 YR