MAUDE Adverse Event Report: THERAKOS CELLEX PHOTOPHERESIS SYSTEM

Model Number NOT APPLICABLE

Device Problems Partial Blockage (1065); Device Displays Incorrect Message (2591)

Patient Problems Low Blood Pressure/ Hypotension (1914); Nausea (1970); Blood Loss (2597)

Event Date 11/22/2017

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.This case is reportable as a mdr due to the reportable malfunction of the clot in the return line.Since this reportable malfunction is only associated with the kit, this mdr will only be against the kit.A batch record review of kit lot f238 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot f238 for the reported complaint issue shows no trends.Trends were reviewed for complaint categories, alarm #17: return pressure, clot observed, nausea, and hypotension.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.(b)(4).

Event Description

The customer called to report alarm #17: return pressure alarms and clot observed during a single needle mode extracorporeal photopheresis (ecp) treatment procedure.The customer stated that multiple alarm 17: return pressure alarms occurred after 405 ml of whole blood processed.The customer reported that they had to pause the treatment for more than ten minutes without any movement of the fluid within the kit due to losing the patient's access.The customer stated that when they disconnected the patient's access, they observed clotting in the return line.The customer reported that the treatment was then aborted with no return of blood/products to the patient.The customer stated that the patient's extracellular volume was -109 ml at this moment.The customer reported that the patient complained about nausea after the event.The customer also stated that the patient experienced hypotension and as a result the patient received a 500 ml saline infusion.The customer reported that the patient stabilized with the provided 500 ml saline infusion and underwent another ecp treatment procedure the following day without any issues.The customer stated that the patient was in stable condition.The customer reported that the patient was also being treated with a 25gr infusion of kiovig along with the patient's ecp treatment procedure.The customer stated that kiovig is an immunglobulin, and it is part of the patient's over all treatment.The customer reported that the kiovig infusion was given along with the patient's ecp treatment but over another venous access.The customer stated that the patient's physician has now decided to no longer perform the patient's kiovig infusions in parallel with the patient's ecp treatments.The customer reported that heparin was used as the anticoagulant for this treatment at a ratio of 8.1 (10000 iu in 500 ml saline).The customer stated that they did not want to return the kit for investigation.The kit was not returned for investigation.This medwatch is for the reportable malfunction of the clot in the return line.The adverse events, nausea and hypotension, were submitted under medwatch 2523595-2017-00236.

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS; bedminster NJ
• Manufacturer (Section G): THERAKOS, INC.; 10 north high street; suite 300; west chester PA 19380
• Manufacturer Contact: megan vernak ; 1425 us route 206; bedminster, NJ 07921
• MDR Report Key: 7128040
• MDR Text Key: 96052793
• Report Number: 2523595-2017-00235
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 12/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 07/01/2019
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXECP
• Device Lot Number: F238
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/22/2017
• Initial Date FDA Received: 12/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Weight: 91