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

Model Number NOT APPLICABLE

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/08/2017

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.This case is reportable as a mdr due to the reportable malfunctions of the drive tube leak/break and 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 of kit lot e344 was conducted.There were no non-conformances related to the complaint.This lot met all release requirements.A review of kit lot e344 for the reported complaint issue shows no trends.Trends were reviewed for complaint categories, drive tube leak/break and centrifuge bowl leak/break.No trends were detected for each complaint category.A photo analysis was conducted for this complaint.A review of the photos verified the drive tube leak/break and centrifuge bowl leak/break; however, the cause of the break could not be determined based on the information provided.No further action required.This investigation is now complete.(b)(4).Device not returned.

Event Description

Customer called to report the drive tube, and centrifuge bowl broke during the procedure.At the time of break approximately 200 ml whole blood had been processed.The customer aborted the procedure and did not return blood/fluids to the patient.Customer stated the patient is in stable condition.The customer has returned photographs 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 ; 53 frontage road; p.o. box 9001; hampton, NJ 08827
• MDR Report Key: 6610701
• MDR Text Key: 76952801
• Report Number: 2523595-2017-00099
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 20705030200003
• UDI-Public: (01)20705030200003(10)E344(17)180801
• 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
• Report Date: 06/05/2017

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: 08/01/2018
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXUSA
• Device Lot Number: E344
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/08/2017
• Initial Date FDA Received: 06/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2016
• 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: 32 YR
• Patient Weight: 145