MAUDE Adverse Event Report: THERAKOS, INC CELLEX PHOTOPHERESIS SYSTEM

Model Number NOT APPLICABLE

Device Problems Bent (1059); Break (1069); Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/24/2017

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 f311 was conducted.There were no non-conformances related to the complaint.This lot met all release requirements.A review of kit lot f311 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 photos is still in progress.A supplemental report will be filed when the analysis is complete.(b)(4).Not returned to manufacturer.

Event Description

The customer has called to report a bowl break during a treatment procedure.The prime was successful without any issues or alarms.The customer states it appears that the bowl broke off at the connection point with the drive tube.The drive tube latches were found to be bent and will need to be replaced.The patient was in stable condition throughout this whole event.The doctor was present when the break occurred and cleared the patient for a second try on another cellex instrument.The second attempt was successful with no issues or alarms.There was no medication intervention or transfusions needed.The patient was stable throughout the whole incident and was released.

Manufacturer Narrative

The customer photographs were returned for investigation.Review of the photographs verified that the centrifuge bowl is broken.The bowl cover and parts of the bowl were still locked into the instrument platen.Review of the components used to build the kit lot found no related non-conformances.The complaint kit lot met all release requirements.A root cause of the centrifuge bowl break could not be determined based on the available information.No further action is required.Investigation complete.Investigation complete.(b)(4),.

• 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 ; 53 frontage road po box 9001; hampton, NJ 08827
• MDR Report Key: 6652993
• MDR Text Key: 78145592
• Report Number: 2523595-2017-00098
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 20705030200003
• UDI-Public: (01)20705030200003(10)F311(17)190301
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/20/2017

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: 03/01/2019
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXUSA
• Device Lot Number: F311
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/24/2017
• Initial Date FDA Received: 06/20/2017
• Supplement Dates Manufacturer Received: 07/14/2017
• Supplement Dates FDA Received: 07/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2017
• 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