MAUDE Adverse Event Report: THERAKOS CELLEX PHOTOPHERESIS SYSTEM

Model Number NOT APPLICABLE

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/27/2017

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.This case is reportable as a mdr due to the reportable malfunction centrifuge bowl leak/break.Since this reportable malfunction is only associated with the kit, this mdr will only be against the kit.A batch record review for kit lot f230 was conducted.There were no non-conformances.This lot met all release requirements.A review of f230 for the reported issue shows no trends.Trends were reviewed for complaint categories centrifuge bowl leak/break, alarm #16: collect pressure.No trends were detected for each complaint category.A photograph analysis was conducted for this complaint.A review of the photographs confirmed the reported centrifuge bowl break occurred during treatment.However, the provided photographs do not provide enough information to determine a root cause for the reported incident.A device history record review did not result in any related non-conformance's for this kit lot.In addition, a material trace of the centrifuge bowl component used to build kit lot f230 did not identify any non-conformances.Centrifuge bowls are leak tested at the assembly level and again during finished product testing.Kit lot f230 passed all testing requirements prior to product release.No further actions are required at this time.Investigation complete.

Event Description

Customer called to report a centrifuge bowl leak/ break that occurred during the purging air phase of the procedure.The customer mentioned that an alarm #16: collect pressure occurred during the treatment and that this was "normal regarding the patient veins".There was no blood returned to the patient.The patient was not impacted by the incident and was said to be in stable condition.The customer provided photographs of the reported incident to be investigated.

• 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: 6973788
• MDR Text Key: 90879878
• Report Number: 2523595-2017-00191
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 10/24/2017

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: 06/01/2019
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXECP
• Device Lot Number: F230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/27/2017
• Initial Date FDA Received: 10/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2017
• 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