MAUDE Adverse Event Report: THERAKOS CELLEX PHOTOPHERESIS SYSTEM

Model Number NOT APPLICABLE

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

Patient Problems Dyspnea (1816); Erythema (1840); Low Blood Pressure/ Hypotension (1914); Swelling (2091); Tachycardia (2095)

Event Date 04/24/2018

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 benadryl, hydrocortisone and chlorpheniramine that were provided to the patient.Since this event is associated with the treatment, this mdr will be against the instrument.From the instrument perspective, there was no known instrument 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 (b)(6) 2017.As part of the review, it was determined that the instrument's last service was on (b)(6) 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.Trends were reviewed for complaint categories, other adverse event: dyspnea, heart rate increased, hypotension, swelling, and face/neck flushing.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: dyspnea, tachycardia, hypotension, swelling, and erythema.(b)(4).

Event Description

The customer called to report that a patient experienced dyspnea, heart rate increase, hypotension, swelling, and face/neck flushing during a blood prime extracorporeal photopheresis (ecp) treatment procedure.The customer stated that the patient had difficulty breathing, became tachycardic, and their blood pressure dropped during the blood prime treatment procedure.The customer reported that the patient started to show some swelling in their face and became red.The customer stated that the patient was apyrexial during the event.The customer reported that they administered benadryl to the patient, however the patient's symptoms did not resolve.The customer stated that the medics were called in and the patient's treatment procedure was stopped.The customer reported that they did not return any blood/products to the patient and they wanted to know if there was anyway to know how much of the packed red blood cell unit may have already gone back to the patient.The customer stated that they are treating this event as a blood transfusion reaction and a sample of the patient's blood was sent for testing in order to confirm this.The customer reported that the treatment procedure was stopped at 916ml of whole blood processed.The customer stated that the patient was given hydrocortisone and chlorpheniramine, iv, in order to treat their transfusion reaction and the patient is now in stable condition.The customer reported that this was the patient's twenty third-treatment procedure.The customer stated that the patient was stable at the start of the treatment procedure; however, the patient did experience a hypertensive episode the night before.The customer reported that the patient has an underlying condition of hypertension and nefedipine was administered to the patient just prior to their ecp treatment procedure due to their high blood pressure.The customer stated that they are no longer continuing with this patient's ecp treatments due to their reluctance to give the patient another blood prime.The customer reported that they are now trying to come up with a strategy in order to allow this patient to continue with their ecp treatments.The customer stated that the patient's condition is unchanged and the patient continues to be treated as an inpatient.No product was returned for investigation.

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS; bedminster NJ
• Manufacturer (Section G): MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED; college business & tech park; cruiserath road; blanchardstown, dublin D15 T X2V; EI D15 TX2V
• Manufacturer Contact: megan vernak ; 1425 us route 206; bedminster, NJ 07921
• MDR Report Key: 7488970
• MDR Text Key: 107442193
• Report Number: 2523595-2018-00089
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 10705030100009
• UDI-Public: (01)10705030100009(11)170105
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/04/2018

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: 04/24/2018
• Initial Date FDA Received: 05/04/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2017
• 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: 9 YR
• Patient Weight: 18