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

Model Number NOT APPLICABLE

Device Problems Crack (1135); Fluid/Blood Leak (1250)

Patient Problem Blood Loss (2597)

Event Date 12/20/2017

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 f353 was conducted.There were no non-conformances.This lot met all release requirements.A review of kit lot f353 for the reported issue shows no trends.Trends were reviewed for complaint categories, centrifuge bowl leak/break, alarm #7: blood leak (centrifuge chamber).No trends were detected for each 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 kit and photographs is still in progress.A supplemental report will be filed when the analysis is complete.

Event Description

The customer called to report a centrifuge bowl leak during the treatment procedure.The customer stated approximately 214 ml of whole blood was processed before the alarm #7: blood leak (centrifuge chamber) and centrifuge bowl leak occurred.The customer stated they observed a crack in the centrifuge bowl.The customer aborted the treatment and did not return blood to the patient.The customer stated the patient was stable and had started treatment on a different instrument.The customer has returned the kit and photographs for investigation.

Manufacturer Narrative

The complaint kit, smart card and photographs were returned for investigation.A review of the data recorded on the smart card identified an alarm #7: blood leak (centrifuge chamber) was received.The data on the smart card also identified that the kit prime and purging air phase were completed without incident.The returned kit components were examined and confirm the outer part of the centrifuge bowl was cracked between the base and the cover.The crack in the centrifuge bowl was approximately 3/4 the way around the circumference of the bowl and was not a separation in the weld between the two components, indicating a weld failure was not likely to be the cause of the centrifuge bowl break.The drive tube was examined and was intact and had no signs of wear or contact against another item.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).

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS, INC.; bedminster NJ 07921
• MDR Report Key: 7198293
• MDR Text Key: 98050976
• Report Number: 2523595-2018-00015
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 20705030200003
• UDI-Public: (01)20705030200003(10)F353(17)190901
• Combination Product (y/n): N
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 02/09/2018

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: 09/01/2019
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXUSA
• Device Lot Number: F353
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/20/2017
• Initial Date FDA Received: 01/16/2018
• Supplement Dates Manufacturer Received: 01/17/2018
• Supplement Dates FDA Received: 02/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 55 YR