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

Model Number NOT APPLICABLE

Device Problems Break (1069); Unintended Ejection (1234)

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

Event Date 08/13/2018

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 g326 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot g326 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 returned kit is still in progress.A supplemental report will be filed when the analysis is complete.(b)(4).

Event Description

The customer called to report a centrifuge bowl leak/break during the treatment procedure.The customer stated approximately 200 ml of whole blood was processed when the break occurred.The customer aborted the treatment and did not return blood to the patient.The customer stated the patient was stable.The customer has returned the kit for investigation.

Manufacturer Narrative

The complaint kit was returned for investigation.The returned kit components were examined and the centrifuge bowl break was confirmed.The centrifuge bowl had a crack running around the circumference of the outer bowl.The crack was above the welded area between the outer bowl cover and the outer bowl.The drive tube component was examined and found to be intact with both drive tube bearings still attached to the drive tube.Examination of the returned kit components indicated the break occurred in the parent material of the bowl and not a separation at the weld that joins the components.A material trace of the bowl assembly and its components used to build lot g326 found no related non-conformances.A device history record review did not identify any related non-conformances, and this kit lot had passed all lot release testing.The investigation determined the root cause of the centrifuge bowl break was due to a material failure in the parent material of the outer bowl.However, the cause of the material failure could not be determined based on the available information.No manufacturing related defects were identified through this investigation.No further action is required at this time.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: 7870817
• MDR Text Key: 120264180
• Report Number: 2523595-2018-00136
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 20705030200003
• UDI-Public: (01)20705030200003(10)G326(17)200401
• 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
• Type of Report: Initial,Followup
• Report Date: 10/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2020
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXUSA
• Device Lot Number: G326
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2018
• Date Manufacturer Received: 09/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1