MAUDE Adverse Event Report: THERAKOS CELLEX PHOTOPHERESIS SYSTEM

Model Number NOT APPLICABLE

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

Patient Problem Anemia (1706)

Event Date 06/15/2018

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 ferric carboxymaltose that was 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 22-may-2017.As part of the review, it was determined that the instrument's last service was on 21-may-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 category, anemia.No trends were detected for this complaint category.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: anemia.(b)(4).

Event Description

The customer called to report that a patient developed anemia while undergoing extracorporeal photopheresis (ecp) treatment procedures.The customer stated that the patient started their ecp treatment procedures on (b)(6) 2018.The customer reported that the patient received two ecp treatment procedures every week.The customer stated that the patient was diagnosed with anemia on (b)(6) 2018.The customer reported that after the patient's anemia diagnosis, the patient's ecp treatment frequency was changed from twice weekly to twice every other week.The customer stated that the patient also received two doses of 750mg ferric carboxymaltose, which helped the patient.The customer reported that the patient only received one treatment with their new treatment frequency of twice every other week; so it was difficult to say whether this new treatment frequency helped the patient.The customer stated that the patient's ecp treatments were stopped due to the patient's severe anemia and also due to the fact that the patient's skin improvements had reached a plateau.The customer reported that the patient's last ecp treatment procedure was on (b)(6) 2018.The customer stated that both the patient's iron and hemoglobin levels are now within normal limits.The customer reported that the patient was in stable condition.The customer stated that she believed that the patient's ecp treatments and its twice weekly regimen contributed to the patient's anemia.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: 7896608
• MDR Text Key: 120969348
• Report Number: 2523595-2018-00148
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 08/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2014
• 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: 56 YR