MAUDE Adverse Event Report: THERAKOS CELLEX PHOTOPHERESIS SYSTEM

Model Number NOT APPLICABLE

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Information (3190)

Event Date 03/01/2018

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 saline that were given to the patient.Since this event is associated with the treatment, this mdr will be against the instrument.No product was returned therefore, a device service history review was performed.The instrument has been located at the customer's site since 04-mar-2014.As part of the review, it was determined that the instrument's last service was on 26-feb-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.No service was requested by the customer for this adverse event.Trends were reviewed for complaint categories, alarm #19: fluid balance limit and other adverse event: felt hypovolemic.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: other: felt hypovolemic.(b)(4).

Event Description

The customer called to report that a patient "felt hypovolemic" during a treatment procedure.The customer stated that the patient "felt hypovolemic" (the patient's specific symptoms were requested but not provided) during the treatment procedure and several (unspecified number) of saline boluses were administered to the patient.The customer reported that an alarm 19: fluid balance limit alarm then occurred.The customer stated that the patient's fluid balance limit was at +1000 ml after reinfusion of the treated cells.The customer reported that there was still 400 mls in the return bag, which could not be given back to the patient by the instrument since the alarm could not be reset.The customer was informed that they had reached the upper fluid balance limit for the instrument and the instrument would not return any additional fluids to the patient.The customer was recommended to speak with their physician regarding the return of the additional 400 mls to the patient.The customer reported that they had already spoken with their physician who had approved of the infusion of the return bag to the patient.The customer was then informed that they would have to perform a manual return in order to return the reminder of the return bag to the patient.The customer stated that they understood.The customer reported that they considered this incident as non-serious and that the patient was in stable condition.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: 7384227
• MDR Text Key: 103917179
• Report Number: 2523595-2018-00050
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 03/29/2018

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 APPLICALBLE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/01/2018
• Initial Date FDA Received: 03/29/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2013
• 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): Required Intervention