MAUDE Adverse Event Report: THERAKOS, INC. CELLEX PHOTOPHERESIS SYSTEM

Model Number NOT APPLICABLE

Device Problems Break (1069); Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/03/2017

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 f108 was conducted.There were no non-conformances related to the complaint.This lot met all release requirements.A review of kit lot f108 for the reported issue shows no trends.Trends were reviewed for complaint category, centrifuge bowl leak/break.No trends were detected for this complaint category.This assessment is based on the information available at the time of the investigation.At the time of this report, the analysis of the customer provided photographs is still in progress.A supplemental report will be filed when the analysis is complete.(b)(4).

Event Description

Customer called to report a centrifuge bowl leak/break during the treatment procedure.The customer stated the bowl break occurred during the purging air phase of the procedure.The customer immediately stopped the treatment and disconnected the patient.The customer stated the patient was stable and not affected by the incident.The customer will not be returning the kit; however, has returned photographs for investigation.

Manufacturer Narrative

A photo analysis was conducted for this complaint.A review of the customer provided photographs verified that the centrifuge bowl broke during the treatment.Additionally the photograph shows that the bowl cover is still locked into the centrifuge bowl holder on the instrument, with sections of the outer centrifuge bowl still attached.A material trace of the bowl assembly and its components used to build lot f108 found no related nonconformances.The device history record review did not result in any related non-conformances and this kit lot had passed all lot release testing.The root cause of the centrifuge bowl break could not be determined based on the information provided.This investigation is now complete.(b)(4).(b)(6) 2017.

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS, INC.; bedminster NJ 07921
• 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: 6985195
• MDR Text Key: 91528590
• Report Number: 2523595-2017-00193
• 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,u
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 02/01/2019
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXECP
• Device Lot Number: F108
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/14/2017
• 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