MAUDE Adverse Event Report: THERAKOS CELLEX PHOTOPHERESIS SYSTEM

Model Number NOT APPLICABLE

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems High Blood Pressure/ Hypertension (1908); No Information (3190)

Event Date 02/09/2018

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 calcium that was given to the patient.Since this event is associated with the treatment, this mdr will be against the instrument.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) 2016.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, increased blood pressure and hypocalcemia.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: hypertension and other: hypocalcemia.

Event Description

The customer called to report that the patient experienced hypertension and hypocalcemia during a treatment procedure.The customer stated that there were no alarms either during prime or the treatment procedure.The customer reported that the patient experienced hypertension during the buffy coat collection phase of the treatment.The customer stated that the patient felt better as soon as the patient was able to urinate.The customer also reported that the patient exhibited symptoms of hypocalcemia after the buffy coat collection phase of the treatment, and calcium was administered to the patient.The customer stated that the patient exhibited no other symptoms after receiving the calcium.The customer reported that the treatment was then successfully completed with the treated cells re-infused back to the patient.The customer stated that the patient was in good/safe condition at the end of the treatment.In a follow-up with the customer on (b)(6) 2018, the customer reported that the patient had an underlying condition of hypertension and the patient also did not take his hypertension medication on that day.The customer reported that the patient does not follow the clinician's advice related to a healthy diet, and that the patient eats and drinks more than advised.The customer stated that they also believed that the patient's hypocalcemia symptoms were due to the anticoagulant, acda (10:1 ratio), that they chose to use for this treatment.The customer reported that they administered 10ml/100ml saline/10 min, iv of calcium to the patient when they first noticed the patient's hypocalcemia symptoms.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: 7326259
• MDR Text Key: 101962001
• Report Number: 2523595-2018-00040
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• 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
• Date Manufacturer Received: 02/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2015
• 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