MAUDE Adverse Event Report: THERAKOS, INC CELLEX PHOTOPHERESIS SYSTEM

Model Number NOT APPLICABLE

Device Problems Fluid/Blood Leak (1250); Material Fragmentation (1261); Leak/Splash (1354); Device Operates Differently Than Expected (2913); Physical Property Issue (3008)

Patient Problem Blood Loss (2597)

Event Date 11/29/2016

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.A batch record review of kit lot e345 was conducted.There were no nonconformances associated with this lot.The lot met release requirements.Trends were reviewed for complaint categories, alarm #7: blood leak (centrifuge chamber) and centrifuge bowl leak/break.No trends were detected for these complaint categories.An issue review was initiated for complaint category, centrifuge bowl leak/break.This assessment is based on information available at the time of the investigation.At the time of this report, the analysis of the returned kit photo is still in progress.A supplemental report will be filed when the analysis of the kit photo is complete.(b)(4).Device not returned to manufacturer.

Event Description

The customer called to report a centrifuge bowl leak/break and an alarm #7: blood leak (centrifuge chamber) alarm.The customer stated that the centrifuge bowl shattered after 150ml of whole blood processed.The customer reported that the treatment was aborted with no blood/products returned to the patient.The customer stated that the patient was in stable condition.The customer reported that the drive tube bearings were still in tact but the leak detector strip was damaged.A photo was submitted for investigation.

Manufacturer Narrative

A photo analysis was conducted for this complaint.A review of the photo confirmed the centrifuge bowl break.However, the root cause for the centrifuge bowl break could not be determined based on the information provided.A review of the device history record for this kit lot did not identify any related nonconformances.A material trace of the bowl assembly and its components used to build this kit lot also found no related nonconformances.A capa was initiated at the manufacturing site in order to further investigate the root cause and associated corrective actions for centrifuge bowl leak/breaks.This investigation is now complete.(b)(4).Device not returned to manufacturer.

• 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 ; po box 9001; 53 frontage road; hampton, NJ 08827
• MDR Report Key: 6207815
• MDR Text Key: 63704680
• Report Number: 2523595-2016-00284
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 20705030200003
• UDI-Public: (01)20705030200003(10)E345(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,Followup
• Report Date: 12/27/2016

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: E345
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/29/2016
• Initial Date FDA Received: 12/27/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2016
• 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: 29 YR
• Patient Weight: 70