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 Low Blood Pressure/ Hypotension (1914); Dizziness (2194); Malaise (2359)

Event Date 07/18/2018

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 ringer's lactate solution 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 20-oct-2012.The customer has their own biomed who performs all the service for this instrument.Therakos did perform a system checkout procedure on this instrument on 6-nov-2017 during a software upgrade for this instrument.During this upgrade 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, dizziness, malaise, and hypotension.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: dizziness, malaise, and hypotension.(b)(4).

Event Description

The customer called to report that a patient experienced dizziness, malaise, and hypotension during an extracorporeal photopheresis (ecp) treatment procedure.The customer stated that after 430 ml of whole blood processed, the patient complained of being dizzy and of not feeling well.The customer reported that the patient also developed hypotension with a blood pressure of 86/60.The customer stated that the patient was put in the trendelenburg position and 750 ml of ringer's lactate solution was administered to the patient.The customer reported that the patient then recovered and was in stable condition again.The customer stated that the patient's electrocardiogram was normal and that the patient's blood count showed no major changes.The customer reported that no further investigations were planned and that the patient was not admitted to the hospital.The customer stated that the patient then reported that she had not eaten that morning nor had she had anything to drink prior to the procedure.The patient's physician reported that the patient's lack of nutrition and their dehydration, directly caused the patient's symptoms.The customer stated that they were able to continue with the patient's treatment and that the treatment was successfully completed without any further problems.The customer reported that the treated cells were reinfused back to the patient.The patient's physician stated that the patient's ecp treatment contributed to the event; as the event was a concurrence of circumstances, one would not have happened without the other.The customer reported that the patient had tolerated their previous ecp treatments well.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: 7770899
• MDR Text Key: 116702375
• Report Number: 2523595-2018-00134
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: 08/09/2018

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: 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
• Initial Date Manufacturer Received: 07/18/2018
• Initial Date FDA Received: 08/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/05/2012
• 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): Required Intervention
• Patient Age: 30 YR
• Patient Weight: 42