MAUDE Adverse Event Report: THERAKOS, INC CELLEX PHOTOPHERESIS SYSTEM

Model Number NOT APPLICABLE

Device Problem Insufficient Information (3190)

Patient Problem Fainting (1847)

Event Date 04/12/2017

Event Type  Injury  

Manufacturer Narrative

The system was used for treatment.Out of an abundance of caution, 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.From the device perspective, there was no known device 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 03/29/2017.As part of the review, it was determined that the instrument's last service was on 03/30/2017.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, clot observed and fainting.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: fainting.(b)(4).

Event Description

The customer emailed to report that a patient felt faint during a treatment procedure.The customer stated that this was the second time that they had treated this patient.The customer reported that they used the anticoagulant, acda, due to the patient's very high platelet levels.The customer stated that the patient's line clotted off after the purging air phase of the treatment.The customer reported that the patient felt a little faint.The customer stated that they administered extra calcium (iv) and saline to the patient and that the patient was fine after these administrations.The customer reported that due to the repeated clotting problems in the patient's central line, the treatment was aborted with no blood/products returned to the patient.The customer stated that the patient's blood pressure was fine and the patient was discharged home.The instrument was not returned for investigation.

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS, INC; hampton NJ
• Manufacturer (Section G): THERAKOS, INC.; 10 north high street; suite 300; west chester PA 19380
• Manufacturer Contact: megan vernak ; po box 9001; 53 frontage road; hampton, NJ 08827
• MDR Report Key: 6549660
• MDR Text Key: 74586194
• Report Number: 2523595-2017-00087
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 10705030100009
• UDI-Public: (01)10705030100009(11)170109
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/05/2017

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
• Initial Date Manufacturer Received: 04/12/2017
• Initial Date FDA Received: 05/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/09/2017
• 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